<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03775512</url>
  </required_header>
  <id_info>
    <org_study_id>BWI_2017_07</org_study_id>
    <nct_id>NCT03775512</nct_id>
  </id_info>
  <brief_title>Evaluation of QDOT MICRO™ Catheter for Pulmonary Vein Isolation in Subjects With Paroxysmal Atrial Fibrillation</brief_title>
  <acronym>Q-FFICIENCY</acronym>
  <official_title>Evaluation of QDOT MICRO™ Catheter for Pulmonary Vein Isolation (PVI) in Subjects With PAF</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Biosense Webster, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Biosense Webster, Inc.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective, non-randomized, pre-market clinical evaluation of the QDOT MICRO™ Catheter to&#xD;
      demonstrate the safety and effectiveness when compared to an historical control performance&#xD;
      goal.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective, non-randomized, pre-market clinical evaluation of the QDOT MICRO™ Catheter to&#xD;
      demonstrate the safety and effectiveness when compared to an historical control performance&#xD;
      goal.&#xD;
&#xD;
      the trial has two arms: main arm and second arm (variable flow). The main arm will enroll 185&#xD;
      subjects and second arm will enroll 92 subjects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 30, 2019</start_date>
  <completion_date type="Actual">February 17, 2022</completion_date>
  <primary_completion_date type="Actual">February 17, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Early Onset Primary Adverse Events (PAEs): Atrio-esophageal Fistula and Pulmonary Vein (PV) Stenosis</measure>
    <time_frame>Up to 90 days (post initial and repeated ablation procedure)</time_frame>
    <description>An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. A Primary AEs is an event which occurred within 90 days following initial and repeated ablation procedure using the QDOT MICRO. Primary AEs included: atrio-esophageal fistula and pulmonary vein stenosis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Early Onset PAEs: Death, Myocardial Infraction, Cardiac Tamponade/Perforation, Thromboembolism, Stroke/Cardiovascular Accident , TIA, PNP, Heart Block, Pulmonary Edema, Vagal Nerve Injury, Pericarditis, and MVAC/Bleeding</measure>
    <time_frame>Up to 7 days (post initial and repeated ablation procedure)</time_frame>
    <description>A Primary AEs is an event which occurred within the first week (7 days of the initial and repeated ablation procedure) which included death, myocardial infraction (MI), cardiac tamponade (CT)/perforation, thromboembolism, stroke/cardiovascular accident (CVA), transient ischemic attack (TIA), phrenic nerve paralysis (PNP), heart block, pulmonary edema, vagal nerve injury, pericarditis, and major vascular access complication/bleeding (MVAC).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Freedom From Documented Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes or Other Failure Modes</measure>
    <time_frame>Day 91 to Day 365</time_frame>
    <description>Percentage of participants with freedom from documented AF, AT, or AFL episodes or following failure modes: a) Acute procedural: Failure to confirm entrance block in all pulmonary veins post-procedure and use of a non-study catheter to treat left atrial ablation targets and Cavo-tricuspid isthmus; b) Repeat ablation: &gt;2 repeat ablation procedures with the study catheter during the 3-Month blanking period (Day 0-90) after the index ablation procedure, use of a non-study catheter to treat study arrhythmia ablation targets during the blanking period, and any repeat ablation procedure during the Evaluation Period; c) Antiarrhythmic drug: taking a new AAD for AF or a previously failed AAD at a greater than the highest ineffective historical dose for AF during the evaluation period, were reported.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Unanticipated Adverse Device Effects (UADEs)</measure>
    <time_frame>Up to 20 months</time_frame>
    <description>Number of participants with UADEs were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Serious Non-Primary Adverse Events (SAEs) Within 7 Days (Early Onset), 8-30 Days (Peri-procedural) and Greater Than or Equal to (&gt;=) 31 Days (Late Onset) of Initial Ablation Procedure</measure>
    <time_frame>Within 7 days (early onset), 8-30 days (peri-procedural) and &gt;=31 days (late onset) of initial ablation procedure (up to 20 months)</time_frame>
    <description>Number of participants with serious non-primary AEs within 7 days (early onset), 8-30 days (peri-procedural) and &gt;=31 days (late onset) of initial ablation were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset</measure>
    <time_frame>Within 7 days (early onset), 8-30 days (peri-procedural) and &gt;=31 days (late onset) of initial ablation procedure (up to 20 months)</time_frame>
    <description>Number of participants with bleeding complication (ISTH definitions): a) major, b) clinically relevant non-major and c) minor bleeding were reported. The ISTH classification of major bleeding event is a hemoglobin drop of greater than or equal to (&gt;=) 2 grams per deciliter (g/dL), transfusion of &gt;= 2 units (U) packed red blood cells, symptomatic bleed in a critical area, or fatal bleed. Clinically relevant non-major (CRNM) events require prolong hospitalization or result in laboratory testing, imaging, compression, procedure, interruption of the study medication or a change in concomitant therapy. Minor bleeding events are overt bleeding events that do not meet the criteria for CRNM or major bleeding events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Electrical Isolation of Pulmonary Veins (PVs) (Entrance Block) at the End of the Procedure</measure>
    <time_frame>End of the Procedure (up to 20 months)</time_frame>
    <description>Percentage of participants with electrical isolation of PVs (entrance block) at the end of the procedure were reported</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Electrical Isolation of PV After First Encirclement With Acute Reconnection</measure>
    <time_frame>Up to 20 months</time_frame>
    <description>Percentage of participants with electrical isolation of PV after first encirclement with acute reconnection were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Electrical Isolation of PV After First Encirclement Without Acute Reconnection</measure>
    <time_frame>Up to 20 months</time_frame>
    <description>Percentage of participants with electrical isolation of PV after first encirclement without acute reconnection were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Pulmonary Veins (PV) Touch-up</measure>
    <time_frame>Up to 20 months</time_frame>
    <description>Percentage of participants with PV touch-up were reported. PV touch-up was defined as additional ablations being performed after first encirclement for targeted veins with acute reconnection.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Targeted Veins With Touch-up (Ablation of Acute Reconnection) Among All Targeted Veins</measure>
    <time_frame>Up to 20 months</time_frame>
    <description>Percentage of targeted veins with touch-up (ablation of acute reconnection) among all targeted veins were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement</measure>
    <time_frame>Up to 20 months</time_frame>
    <description>Percentage of participants with touch-up at anatomical location of acute PV reconnection after first encirclement was reported. The location included anterior, superior, ridge, posterior, and inferior region of the left pulmonary veins (LPV) and right pulmonary veins (RPV). The review of all ablation targets for the 1 participant with RPV ridge entered by site resulted in reclassification to RPV superior. This outcome measure was planned to be analyzed for specified arm (main arm) only.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Underwent Repeat Ablation Procedures</measure>
    <time_frame>Up to 20 months</time_frame>
    <description>Percentage of participants who underwent repeat ablation procedures were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With PVs Re-isolation Among All of the Targeted PVs at Repeat Procedure</measure>
    <time_frame>Up to 20 months</time_frame>
    <description>Percentage of participants with PVs re-isolation among all of the targeted PVs at repeat procedure were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Requiring New Linear Lesion and/or New Foci Identified During the Repeat Ablation Procedure</measure>
    <time_frame>Up to 20 months</time_frame>
    <description>Percentage of participants requiring new linear lesion and/or new foci identified during the repeat ablation procedure were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With 12-Month Single Procedure Success</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Percentage of participants with 12-month single procedure success were reported. The 12-month single procedure success is defined as freedom from documented AF/AFL/AT recurrence (episodes &gt; 30 seconds) during the evaluation period after a single ablation procedure.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">283</enrollment>
  <condition>Paroxysmal Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Main Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will be ablated with the QDOT Micro Catheter for Pulmonary Vein Isolation with nMARQ RF Generator</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Second Arm (variable flow)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>subjects will be treated with QDOT Micro catheter with variable flow nMARQ RF generator</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>RF Ablation with QDOT Micro</intervention_name>
    <description>Subjects will be ablated using QDOT Micro catheter</description>
    <arm_group_label>Main Arm</arm_group_label>
    <arm_group_label>Second Arm (variable flow)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Symptomatic paroxysmal AF with one electrocardiographically documented AF episode&#xD;
             within 6 months prior to enrollment and a a physician's note indicating recurrent&#xD;
             self-terminating AF within 7 days . Documentation may include electrocardiogram (ECG);&#xD;
             Transtelephonic monitoring (TTM), Holter monitor or telemetry strip.&#xD;
&#xD;
          -  Failed at least one Class I or Class III antiarrhythmic drug as evidenced by recurrent&#xD;
             symptomatic AF, contraindicated, or intolerable to the AAD.&#xD;
&#xD;
          -  Age 18 years or older.&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Previous surgical or catheter ablation for atrial fibrillation.&#xD;
&#xD;
          -  AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac&#xD;
             cause.&#xD;
&#xD;
          -  Previously diagnosed with persistent or long-standing persistent AF and/or Continuous&#xD;
             AF &gt; 7 days.&#xD;
&#xD;
          -  Valve repair or replacement or presence of a prosthetic valve.&#xD;
&#xD;
          -  CABG surgery within the past 6 months (180 days).&#xD;
&#xD;
          -  Any carotid stenting or endarterectomy within the past 6 months.&#xD;
&#xD;
          -  Coronary artery bypass grafting, cardiac surgery, or valvular cardiac surgical&#xD;
             procedure within the past 6 months.&#xD;
&#xD;
          -  Documented left atrium (LA) thrombus within 1 day prior to the index procedure.&#xD;
&#xD;
          -  Documented LA size &gt; 50 mm.&#xD;
&#xD;
          -  Documented LVEF &lt; 40%.&#xD;
&#xD;
          -  Contraindication to anticoagulation (e.g., heparin).&#xD;
&#xD;
          -  MI/PCI within the past 2 months.&#xD;
&#xD;
          -  Documented thromboembolic event (including transient ischemic attack) within the past&#xD;
             12 months.&#xD;
&#xD;
          -  Uncontrolled heart failure or New York Heart Association (NYHA) function class III or&#xD;
             IV.&#xD;
&#xD;
          -  Awaiting cardiac transplantation or other cardiac surgery within the next 12 months.&#xD;
&#xD;
          -  Presence of implanted pacemaker or implantable cardioverter defibrillator (ICD).&#xD;
&#xD;
          -  Women who are pregnant, lactating, or who are of child bearing age and plan on&#xD;
             becoming pregnant during the course of the clinical investigation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Emile Daoud</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ohio State University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jose Osorio</last_name>
    <role>Principal Investigator</role>
    <affiliation>Grandview Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Francis Marchlinksi</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pennsylvania Health System</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michael Cutler</last_name>
    <role>Principal Investigator</role>
    <affiliation>Intermountain Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Andrea Natale</last_name>
    <role>Principal Investigator</role>
    <affiliation>Texas Cardiac Arrhythmia Research Foundation</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Daniel Melby</last_name>
    <role>Principal Investigator</role>
    <affiliation>Abbott Northwestern</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Miguel Valderabanno</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Methodist Hospital Research Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>George Monir</last_name>
    <role>Principal Investigator</role>
    <affiliation>AdventHealth</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Craig Delaughter</last_name>
    <role>Principal Investigator</role>
    <affiliation>Texas Heart Health and Vascular</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Christopher Liu</last_name>
    <role>Principal Investigator</role>
    <affiliation>New York Presbyterian Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Saumil Oza</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ascension St. Vincent's</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ayman Hussein</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Cleveland Clinic</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Robert Fishel</last_name>
    <role>Principal Investigator</role>
    <affiliation>JFK Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kenneth Ellenbogen</last_name>
    <role>Principal Investigator</role>
    <affiliation>VCU</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gery Tomassoni</last_name>
    <role>Principal Investigator</role>
    <affiliation>Baptist Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tristram Bahnson</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Chris Ellis</last_name>
    <role>Principal Investigator</role>
    <affiliation>VUMC</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Emerson Liu</last_name>
    <role>Principal Investigator</role>
    <affiliation>Allegheny College</affiliation>
  </overall_official>
  <overall_official>
    <last_name>David Wilber</last_name>
    <role>Principal Investigator</role>
    <affiliation>Loyola University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Moussa Mansour</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mass. General Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Srinivas Dukkipati</last_name>
    <role>Principal Investigator</role>
    <affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hugh McElderry</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alabama at Birmingham</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ashish Patel</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wakemed Heart and Vascular</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Larry Chinitz</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU Langone Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Luigi DiBiase</last_name>
    <role>Principal Investigator</role>
    <affiliation>Montefiore</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Grandview Medical Center</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35243</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Alabama</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>JFK Medical Center</name>
      <address>
        <city>Atlantis</city>
        <state>Florida</state>
        <zip>33462</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ascension St. Vincent's</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Hospital</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baptist Health</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Abbott Northwestern Hospital Clinic</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center - Albert Einstein</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NYU Langone</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mt. Sinai School of Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York Presbyterian Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>WakeMed Heart &amp; Vascular</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio State University</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Penn Health System</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Heart Health and Vascular</name>
      <address>
        <city>Arlington</city>
        <state>Texas</state>
        <zip>76012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. David's - TCAR</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78758</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Houston Methodist Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Intermountain Medical Center</name>
      <address>
        <city>Murray</city>
        <state>Utah</state>
        <zip>84107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Commonwealth University</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>November 23, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 14, 2018</study_first_posted>
  <results_first_submitted>February 17, 2023</results_first_submitted>
  <results_first_submitted_qc>February 17, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">March 16, 2023</results_first_posted>
  <last_update_submitted>February 17, 2023</last_update_submitted>
  <last_update_submitted_qc>February 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 3, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/12/NCT03775512/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 22, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/12/NCT03775512/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Main Arm: QDOT Micro Catheter</title>
          <description>Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and radiofrequency (RF) ablation using QDOT Micro Catheter for pulmonary vein isolation with nMARQ radiofrequency (RF) generator.</description>
        </group>
        <group group_id="P2">
          <title>Variable Flow Arm: QDOT Micro Catheter</title>
          <description>Participants with symptomatic PAF who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and RF ablation using QDOT Micro Catheter for variable flow with nMARQ RF generator.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="191"/>
                <participants group_id="P2" count="92"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="177"/>
                <participants group_id="P2" count="87"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="162"/>
                <participants group_id="P2" count="75"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Excluded before Catheter insertion</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Discontinued before RF energy applied on inserted catheter</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Due to a late entrance criteria deviation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Main Arm: QDOT Micro Catheter</title>
          <description>Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and radiofrequency (RF) ablation using QDOT Micro Catheter for pulmonary vein isolation with nMARQ radiofrequency (RF) generator.</description>
        </group>
        <group group_id="B2">
          <title>Variable Flow Arm: QDOT Micro Catheter</title>
          <description>Participants with symptomatic PAF who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and RF ablation using QDOT Micro Catheter for variable flow with nMARQ RF generator.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="191"/>
            <count group_id="B2" value="92"/>
            <count group_id="B3" value="283"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63.5" spread="10.69"/>
                    <measurement group_id="B2" value="64.5" spread="9.75"/>
                    <measurement group_id="B3" value="64.0" spread="10.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="75"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="113"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="116"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="170"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="166"/>
                    <measurement group_id="B2" value="71"/>
                    <measurement group_id="B3" value="237"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Early Onset Primary Adverse Events (PAEs): Atrio-esophageal Fistula and Pulmonary Vein (PV) Stenosis</title>
        <description>An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. A Primary AEs is an event which occurred within 90 days following initial and repeated ablation procedure using the QDOT MICRO. Primary AEs included: atrio-esophageal fistula and pulmonary vein stenosis.</description>
        <time_frame>Up to 90 days (post initial and repeated ablation procedure)</time_frame>
        <population>The modified Intent-to-treat (mITT) analysis set included all enrolled participants who met all eligibility criteria and have the investigational device inserted.</population>
        <group_list>
          <group group_id="O1">
            <title>Main Arm: QDOT Micro Catheter</title>
            <description>Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and radiofrequency (RF) ablation using QDOT Micro Catheter for pulmonary vein isolation with nMARQ radiofrequency (RF) generator.</description>
          </group>
          <group group_id="O2">
            <title>Variable Flow Arm: QDOT Micro Catheter</title>
            <description>Participants with symptomatic PAF who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and RF ablation using QDOT Micro Catheter for variable flow with nMARQ RF generator.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Early Onset Primary Adverse Events (PAEs): Atrio-esophageal Fistula and Pulmonary Vein (PV) Stenosis</title>
          <description>An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. A Primary AEs is an event which occurred within 90 days following initial and repeated ablation procedure using the QDOT MICRO. Primary AEs included: atrio-esophageal fistula and pulmonary vein stenosis.</description>
          <population>The modified Intent-to-treat (mITT) analysis set included all enrolled participants who met all eligibility criteria and have the investigational device inserted.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="167"/>
                <count group_id="O2" value="85"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Early Onset PAEs: Death, Myocardial Infraction, Cardiac Tamponade/Perforation, Thromboembolism, Stroke/Cardiovascular Accident , TIA, PNP, Heart Block, Pulmonary Edema, Vagal Nerve Injury, Pericarditis, and MVAC/Bleeding</title>
        <description>A Primary AEs is an event which occurred within the first week (7 days of the initial and repeated ablation procedure) which included death, myocardial infraction (MI), cardiac tamponade (CT)/perforation, thromboembolism, stroke/cardiovascular accident (CVA), transient ischemic attack (TIA), phrenic nerve paralysis (PNP), heart block, pulmonary edema, vagal nerve injury, pericarditis, and major vascular access complication/bleeding (MVAC).</description>
        <time_frame>Up to 7 days (post initial and repeated ablation procedure)</time_frame>
        <population>The mITT analysis set included all enrolled participants who met all eligibility criteria and have the investigational device inserted.</population>
        <group_list>
          <group group_id="O1">
            <title>Main Arm: QDOT Micro Catheter</title>
            <description>Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and radiofrequency (RF) ablation using QDOT Micro Catheter for pulmonary vein isolation with nMARQ radiofrequency (RF) generator.</description>
          </group>
          <group group_id="O2">
            <title>Variable Flow Arm: QDOT Micro Catheter</title>
            <description>Participants with symptomatic PAF who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and RF ablation using QDOT Micro Catheter for variable flow with nMARQ RF generator.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Early Onset PAEs: Death, Myocardial Infraction, Cardiac Tamponade/Perforation, Thromboembolism, Stroke/Cardiovascular Accident , TIA, PNP, Heart Block, Pulmonary Edema, Vagal Nerve Injury, Pericarditis, and MVAC/Bleeding</title>
          <description>A Primary AEs is an event which occurred within the first week (7 days of the initial and repeated ablation procedure) which included death, myocardial infraction (MI), cardiac tamponade (CT)/perforation, thromboembolism, stroke/cardiovascular accident (CVA), transient ischemic attack (TIA), phrenic nerve paralysis (PNP), heart block, pulmonary edema, vagal nerve injury, pericarditis, and major vascular access complication/bleeding (MVAC).</description>
          <population>The mITT analysis set included all enrolled participants who met all eligibility criteria and have the investigational device inserted.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="167"/>
                <count group_id="O2" value="85"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6"/>
                    <measurement group_id="O2" value="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Freedom From Documented Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes or Other Failure Modes</title>
        <description>Percentage of participants with freedom from documented AF, AT, or AFL episodes or following failure modes: a) Acute procedural: Failure to confirm entrance block in all pulmonary veins post-procedure and use of a non-study catheter to treat left atrial ablation targets and Cavo-tricuspid isthmus; b) Repeat ablation: &gt;2 repeat ablation procedures with the study catheter during the 3-Month blanking period (Day 0-90) after the index ablation procedure, use of a non-study catheter to treat study arrhythmia ablation targets during the blanking period, and any repeat ablation procedure during the Evaluation Period; c) Antiarrhythmic drug: taking a new AAD for AF or a previously failed AAD at a greater than the highest ineffective historical dose for AF during the evaluation period, were reported.</description>
        <time_frame>Day 91 to Day 365</time_frame>
        <population>The per-protocol (PP) analysis set included participants who satisfied the following criteria: a) enrolled and meet eligibility criteria, b) had undergone RF ablation, c) were treated with the study catheters, and d) were treated for the study related arrhythmia, without major protocol deviations that deemed to affect the scientific integrity of the study. Here 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Main Arm: QDOT Micro Catheter</title>
            <description>Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and radiofrequency (RF) ablation using QDOT Micro Catheter for pulmonary vein isolation with nMARQ radiofrequency (RF) generator.</description>
          </group>
          <group group_id="O2">
            <title>Variable Flow Arm: QDOT Micro Catheter</title>
            <description>Participants with symptomatic PAF who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and RF ablation using QDOT Micro Catheter for variable flow with nMARQ RF generator.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Freedom From Documented Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes or Other Failure Modes</title>
          <description>Percentage of participants with freedom from documented AF, AT, or AFL episodes or following failure modes: a) Acute procedural: Failure to confirm entrance block in all pulmonary veins post-procedure and use of a non-study catheter to treat left atrial ablation targets and Cavo-tricuspid isthmus; b) Repeat ablation: &gt;2 repeat ablation procedures with the study catheter during the 3-Month blanking period (Day 0-90) after the index ablation procedure, use of a non-study catheter to treat study arrhythmia ablation targets during the blanking period, and any repeat ablation procedure during the Evaluation Period; c) Antiarrhythmic drug: taking a new AAD for AF or a previously failed AAD at a greater than the highest ineffective historical dose for AF during the evaluation period, were reported.</description>
          <population>The per-protocol (PP) analysis set included participants who satisfied the following criteria: a) enrolled and meet eligibility criteria, b) had undergone RF ablation, c) were treated with the study catheters, and d) were treated for the study related arrhythmia, without major protocol deviations that deemed to affect the scientific integrity of the study. Here 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="156"/>
                <count group_id="O2" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.3"/>
                    <measurement group_id="O2" value="67.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Unanticipated Adverse Device Effects (UADEs)</title>
        <description>Number of participants with UADEs were reported.</description>
        <time_frame>Up to 20 months</time_frame>
        <population>The safety analysis set included all enrolled participants of the study who had the investigational device inserted, regardless if RF energy was delivered.</population>
        <group_list>
          <group group_id="O1">
            <title>Main Arm: QDOT Micro Catheter</title>
            <description>Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and radiofrequency (RF) ablation using QDOT Micro Catheter for pulmonary vein isolation with nMARQ radiofrequency (RF) generator.</description>
          </group>
          <group group_id="O2">
            <title>Variable Flow Arm: QDOT Micro Catheter</title>
            <description>Participants with symptomatic PAF who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and RF ablation using QDOT Micro Catheter for variable flow with nMARQ RF generator.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Unanticipated Adverse Device Effects (UADEs)</title>
          <description>Number of participants with UADEs were reported.</description>
          <population>The safety analysis set included all enrolled participants of the study who had the investigational device inserted, regardless if RF energy was delivered.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="177"/>
                <count group_id="O2" value="87"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Serious Non-Primary Adverse Events (SAEs) Within 7 Days (Early Onset), 8-30 Days (Peri-procedural) and Greater Than or Equal to (&gt;=) 31 Days (Late Onset) of Initial Ablation Procedure</title>
        <description>Number of participants with serious non-primary AEs within 7 days (early onset), 8-30 days (peri-procedural) and &gt;=31 days (late onset) of initial ablation were reported.</description>
        <time_frame>Within 7 days (early onset), 8-30 days (peri-procedural) and &gt;=31 days (late onset) of initial ablation procedure (up to 20 months)</time_frame>
        <population>The safety analysis set included all enrolled participants of the study who had the investigational device inserted, regardless if RF energy was delivered.</population>
        <group_list>
          <group group_id="O1">
            <title>Main Arm: QDOT Micro Catheter</title>
            <description>Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and radiofrequency (RF) ablation using QDOT Micro Catheter for pulmonary vein isolation with nMARQ radiofrequency (RF) generator.</description>
          </group>
          <group group_id="O2">
            <title>Variable Flow Arm: QDOT Micro Catheter</title>
            <description>Participants with symptomatic PAF who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and RF ablation using QDOT Micro Catheter for variable flow with nMARQ RF generator.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Serious Non-Primary Adverse Events (SAEs) Within 7 Days (Early Onset), 8-30 Days (Peri-procedural) and Greater Than or Equal to (&gt;=) 31 Days (Late Onset) of Initial Ablation Procedure</title>
          <description>Number of participants with serious non-primary AEs within 7 days (early onset), 8-30 days (peri-procedural) and &gt;=31 days (late onset) of initial ablation were reported.</description>
          <population>The safety analysis set included all enrolled participants of the study who had the investigational device inserted, regardless if RF energy was delivered.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="177"/>
                <count group_id="O2" value="87"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>0 - 7 Days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 - 30 Days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;= 31 Days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset</title>
        <description>Number of participants with bleeding complication (ISTH definitions): a) major, b) clinically relevant non-major and c) minor bleeding were reported. The ISTH classification of major bleeding event is a hemoglobin drop of greater than or equal to (&gt;=) 2 grams per deciliter (g/dL), transfusion of &gt;= 2 units (U) packed red blood cells, symptomatic bleed in a critical area, or fatal bleed. Clinically relevant non-major (CRNM) events require prolong hospitalization or result in laboratory testing, imaging, compression, procedure, interruption of the study medication or a change in concomitant therapy. Minor bleeding events are overt bleeding events that do not meet the criteria for CRNM or major bleeding events.</description>
        <time_frame>Within 7 days (early onset), 8-30 days (peri-procedural) and &gt;=31 days (late onset) of initial ablation procedure (up to 20 months)</time_frame>
        <population>The safety analysis set included all enrolled participants of the study who had the investigational device inserted, regardless if RF energy was delivered.</population>
        <group_list>
          <group group_id="O1">
            <title>Main Arm: QDOT Micro Catheter</title>
            <description>Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and radiofrequency (RF) ablation using QDOT Micro Catheter for pulmonary vein isolation with nMARQ radiofrequency (RF) generator.</description>
          </group>
          <group group_id="O2">
            <title>Variable Flow Arm: QDOT Micro Catheter</title>
            <description>Participants with symptomatic PAF who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and RF ablation using QDOT Micro Catheter for variable flow with nMARQ RF generator.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset</title>
          <description>Number of participants with bleeding complication (ISTH definitions): a) major, b) clinically relevant non-major and c) minor bleeding were reported. The ISTH classification of major bleeding event is a hemoglobin drop of greater than or equal to (&gt;=) 2 grams per deciliter (g/dL), transfusion of &gt;= 2 units (U) packed red blood cells, symptomatic bleed in a critical area, or fatal bleed. Clinically relevant non-major (CRNM) events require prolong hospitalization or result in laboratory testing, imaging, compression, procedure, interruption of the study medication or a change in concomitant therapy. Minor bleeding events are overt bleeding events that do not meet the criteria for CRNM or major bleeding events.</description>
          <population>The safety analysis set included all enrolled participants of the study who had the investigational device inserted, regardless if RF energy was delivered.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="177"/>
                <count group_id="O2" value="87"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Major: 0 - 7 Days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Major: 8 - 30 Days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Major: &gt;= 31 Days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CRNM: 0-7 Days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CRNM: 8-30 Days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CRNM: &gt;= 31 Days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Minor: 0-7 Days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Minor: 8-30 Days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Minor: &gt;= 31 Days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Electrical Isolation of Pulmonary Veins (PVs) (Entrance Block) at the End of the Procedure</title>
        <description>Percentage of participants with electrical isolation of PVs (entrance block) at the end of the procedure were reported</description>
        <time_frame>End of the Procedure (up to 20 months)</time_frame>
        <population>The PP analysis set included participants who satisfied the following criteria: a) enrolled and meet eligibility criteria, b) had undergone RF ablation, c) were treated with the study catheters, and d) were treated for the study related arrhythmia, without major protocol deviations that deemed to affect the scientific integrity of the study. Here 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Main Arm: QDOT Micro Catheter</title>
            <description>Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and radiofrequency (RF) ablation using QDOT Micro Catheter for pulmonary vein isolation with nMARQ radiofrequency (RF) generator.</description>
          </group>
          <group group_id="O2">
            <title>Variable Flow Arm: QDOT Micro Catheter</title>
            <description>Participants with symptomatic PAF who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and RF ablation using QDOT Micro Catheter for variable flow with nMARQ RF generator.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Electrical Isolation of Pulmonary Veins (PVs) (Entrance Block) at the End of the Procedure</title>
          <description>Percentage of participants with electrical isolation of PVs (entrance block) at the end of the procedure were reported</description>
          <population>The PP analysis set included participants who satisfied the following criteria: a) enrolled and meet eligibility criteria, b) had undergone RF ablation, c) were treated with the study catheters, and d) were treated for the study related arrhythmia, without major protocol deviations that deemed to affect the scientific integrity of the study. Here 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="164"/>
                <count group_id="O2" value="82"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Electrical Isolation of PV After First Encirclement With Acute Reconnection</title>
        <description>Percentage of participants with electrical isolation of PV after first encirclement with acute reconnection were reported.</description>
        <time_frame>Up to 20 months</time_frame>
        <population>The PP analysis set included participants who satisfied the following criteria: a) enrolled and meet eligibility criteria, b) had undergone RF ablation, c) were treated with the study catheters, and d) were treated for the study related arrhythmia, without major protocol deviations that deemed to affect the scientific integrity of the study. Here 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Main Arm: QDOT Micro Catheter</title>
            <description>Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and radiofrequency (RF) ablation using QDOT Micro Catheter for pulmonary vein isolation with nMARQ radiofrequency (RF) generator.</description>
          </group>
          <group group_id="O2">
            <title>Variable Flow Arm: QDOT Micro Catheter</title>
            <description>Participants with symptomatic PAF who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and RF ablation using QDOT Micro Catheter for variable flow with nMARQ RF generator.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Electrical Isolation of PV After First Encirclement With Acute Reconnection</title>
          <description>Percentage of participants with electrical isolation of PV after first encirclement with acute reconnection were reported.</description>
          <population>The PP analysis set included participants who satisfied the following criteria: a) enrolled and meet eligibility criteria, b) had undergone RF ablation, c) were treated with the study catheters, and d) were treated for the study related arrhythmia, without major protocol deviations that deemed to affect the scientific integrity of the study. Here 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="164"/>
                <count group_id="O2" value="82"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.7"/>
                    <measurement group_id="O2" value="31.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Electrical Isolation of PV After First Encirclement Without Acute Reconnection</title>
        <description>Percentage of participants with electrical isolation of PV after first encirclement without acute reconnection were reported.</description>
        <time_frame>Up to 20 months</time_frame>
        <population>The PP analysis set included participants who satisfied the following criteria: a) enrolled and meet eligibility criteria, b) had undergone RF ablation, c) were treated with the study catheters, and d) were treated for the study related arrhythmia, without major protocol deviations that deemed to affect the scientific integrity of the study. Here 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Main Arm: QDOT Micro Catheter</title>
            <description>Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and radiofrequency (RF) ablation using QDOT Micro Catheter for pulmonary vein isolation with nMARQ radiofrequency (RF) generator.</description>
          </group>
          <group group_id="O2">
            <title>Variable Flow Arm: QDOT Micro Catheter</title>
            <description>Participants with symptomatic PAF who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and RF ablation using QDOT Micro Catheter for variable flow with nMARQ RF generator.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Electrical Isolation of PV After First Encirclement Without Acute Reconnection</title>
          <description>Percentage of participants with electrical isolation of PV after first encirclement without acute reconnection were reported.</description>
          <population>The PP analysis set included participants who satisfied the following criteria: a) enrolled and meet eligibility criteria, b) had undergone RF ablation, c) were treated with the study catheters, and d) were treated for the study related arrhythmia, without major protocol deviations that deemed to affect the scientific integrity of the study. Here 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="164"/>
                <count group_id="O2" value="82"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.3"/>
                    <measurement group_id="O2" value="68.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Pulmonary Veins (PV) Touch-up</title>
        <description>Percentage of participants with PV touch-up were reported. PV touch-up was defined as additional ablations being performed after first encirclement for targeted veins with acute reconnection.</description>
        <time_frame>Up to 20 months</time_frame>
        <population>The PP analysis set included participants who satisfied the following criteria: a) enrolled and meet eligibility criteria, b) had undergone RF ablation, c) were treated with the study catheters, and d) were treated for the study related arrhythmia, without major protocol deviations that deemed to affect the scientific integrity of the study. Here 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Main Arm: QDOT Micro Catheter</title>
            <description>Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and radiofrequency (RF) ablation using QDOT Micro Catheter for pulmonary vein isolation with nMARQ radiofrequency (RF) generator.</description>
          </group>
          <group group_id="O2">
            <title>Variable Flow Arm: QDOT Micro Catheter</title>
            <description>Participants with symptomatic PAF who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and RF ablation using QDOT Micro Catheter for variable flow with nMARQ RF generator.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Pulmonary Veins (PV) Touch-up</title>
          <description>Percentage of participants with PV touch-up were reported. PV touch-up was defined as additional ablations being performed after first encirclement for targeted veins with acute reconnection.</description>
          <population>The PP analysis set included participants who satisfied the following criteria: a) enrolled and meet eligibility criteria, b) had undergone RF ablation, c) were treated with the study catheters, and d) were treated for the study related arrhythmia, without major protocol deviations that deemed to affect the scientific integrity of the study. Here 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="164"/>
                <count group_id="O2" value="82"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.7"/>
                    <measurement group_id="O2" value="31.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Targeted Veins With Touch-up (Ablation of Acute Reconnection) Among All Targeted Veins</title>
        <description>Percentage of targeted veins with touch-up (ablation of acute reconnection) among all targeted veins were reported.</description>
        <time_frame>Up to 20 months</time_frame>
        <population>The PP analysis set included participants who satisfied the following criteria: a) enrolled and meet eligibility criteria, b) had undergone RF ablation, c) were treated with the study catheters, and d) were treated for the study related arrhythmia, without major protocol deviations that deemed to affect the scientific integrity of the study. Here 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Main Arm: QDOT Micro Catheter</title>
            <description>Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and radiofrequency (RF) ablation using QDOT Micro Catheter for pulmonary vein isolation with nMARQ radiofrequency (RF) generator.</description>
          </group>
          <group group_id="O2">
            <title>Variable Flow Arm: QDOT Micro Catheter</title>
            <description>Participants with symptomatic PAF who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and RF ablation using QDOT Micro Catheter for variable flow with nMARQ RF generator.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Targeted Veins With Touch-up (Ablation of Acute Reconnection) Among All Targeted Veins</title>
          <description>Percentage of targeted veins with touch-up (ablation of acute reconnection) among all targeted veins were reported.</description>
          <population>The PP analysis set included participants who satisfied the following criteria: a) enrolled and meet eligibility criteria, b) had undergone RF ablation, c) were treated with the study catheters, and d) were treated for the study related arrhythmia, without major protocol deviations that deemed to affect the scientific integrity of the study. Here 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure.</population>
          <units>Percentage of Targeted Veins</units>
          <param>Number</param>
          <units_analyzed>Targeted Veins</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="164"/>
                <count group_id="O2" value="82"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Targeted Veins</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="328"/>
                <count group_id="O2" value="164"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.4"/>
                    <measurement group_id="O2" value="20.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement</title>
        <description>Percentage of participants with touch-up at anatomical location of acute PV reconnection after first encirclement was reported. The location included anterior, superior, ridge, posterior, and inferior region of the left pulmonary veins (LPV) and right pulmonary veins (RPV). The review of all ablation targets for the 1 participant with RPV ridge entered by site resulted in reclassification to RPV superior. This outcome measure was planned to be analyzed for specified arm (main arm) only.</description>
        <time_frame>Up to 20 months</time_frame>
        <population>The PP set had participants who satisfied these criteria: a) enrolled and meet eligibility criteria, b) had undergone RF ablation, c) treated with the study catheters, and d) were treated for the study related arrhythmia, without major protocol deviations that deemed to affect the scientific integrity of the study. Here 'N' (number of participants analyzed) is number of participants analyzed for this endpoint and 'n' (number analyzed) is number of participants analyzed for specified categories.</population>
        <group_list>
          <group group_id="O1">
            <title>Main Arm: QDOT Micro Catheter</title>
            <description>Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and radiofrequency (RF) ablation using QDOT Micro Catheter for pulmonary vein isolation with nMARQ radiofrequency (RF) generator.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement</title>
          <description>Percentage of participants with touch-up at anatomical location of acute PV reconnection after first encirclement was reported. The location included anterior, superior, ridge, posterior, and inferior region of the left pulmonary veins (LPV) and right pulmonary veins (RPV). The review of all ablation targets for the 1 participant with RPV ridge entered by site resulted in reclassification to RPV superior. This outcome measure was planned to be analyzed for specified arm (main arm) only.</description>
          <population>The PP set had participants who satisfied these criteria: a) enrolled and meet eligibility criteria, b) had undergone RF ablation, c) treated with the study catheters, and d) were treated for the study related arrhythmia, without major protocol deviations that deemed to affect the scientific integrity of the study. Here 'N' (number of participants analyzed) is number of participants analyzed for this endpoint and 'n' (number analyzed) is number of participants analyzed for specified categories.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>LPV: Anterior</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LPV: Inferior</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LPV: Posterior</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LPV: Ridge</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LPV: Superior</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RPV: Anterior</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RPV: Inferior</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RPV: Posterior</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RPV: Superior</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Underwent Repeat Ablation Procedures</title>
        <description>Percentage of participants who underwent repeat ablation procedures were reported.</description>
        <time_frame>Up to 20 months</time_frame>
        <population>The PP analysis set included participants who satisfied the following criteria: a) enrolled and meet eligibility criteria, b) had undergone RF ablation, c) were treated with the study catheters, and d) were treated for the study related arrhythmia, without major protocol deviations that deemed to affect the scientific integrity of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Main Arm: QDOT Micro Catheter</title>
            <description>Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and radiofrequency (RF) ablation using QDOT Micro Catheter for pulmonary vein isolation with nMARQ radiofrequency (RF) generator.</description>
          </group>
          <group group_id="O2">
            <title>Variable Flow Arm: QDOT Micro Catheter</title>
            <description>Participants with symptomatic PAF who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and RF ablation using QDOT Micro Catheter for variable flow with nMARQ RF generator.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Underwent Repeat Ablation Procedures</title>
          <description>Percentage of participants who underwent repeat ablation procedures were reported.</description>
          <population>The PP analysis set included participants who satisfied the following criteria: a) enrolled and meet eligibility criteria, b) had undergone RF ablation, c) were treated with the study catheters, and d) were treated for the study related arrhythmia, without major protocol deviations that deemed to affect the scientific integrity of the study.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="166"/>
                <count group_id="O2" value="82"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.8"/>
                    <measurement group_id="O2" value="13.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With PVs Re-isolation Among All of the Targeted PVs at Repeat Procedure</title>
        <description>Percentage of participants with PVs re-isolation among all of the targeted PVs at repeat procedure were reported.</description>
        <time_frame>Up to 20 months</time_frame>
        <population>The PP analysis set included participants who satisfied the following criteria: a) enrolled and meet eligibility criteria, b) had undergone RF ablation, c) were treated with the study catheters, and d) were treated for the study related arrhythmia, without major protocol deviations that deemed to affect the scientific integrity of the study. Here 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Main Arm: QDOT Micro Catheter</title>
            <description>Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and radiofrequency (RF) ablation using QDOT Micro Catheter for pulmonary vein isolation with nMARQ radiofrequency (RF) generator.</description>
          </group>
          <group group_id="O2">
            <title>Variable Flow Arm: QDOT Micro Catheter</title>
            <description>Participants with symptomatic PAF who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and RF ablation using QDOT Micro Catheter for variable flow with nMARQ RF generator.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With PVs Re-isolation Among All of the Targeted PVs at Repeat Procedure</title>
          <description>Percentage of participants with PVs re-isolation among all of the targeted PVs at repeat procedure were reported.</description>
          <population>The PP analysis set included participants who satisfied the following criteria: a) enrolled and meet eligibility criteria, b) had undergone RF ablation, c) were treated with the study catheters, and d) were treated for the study related arrhythmia, without major protocol deviations that deemed to affect the scientific integrity of the study. Here 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Requiring New Linear Lesion and/or New Foci Identified During the Repeat Ablation Procedure</title>
        <description>Percentage of participants requiring new linear lesion and/or new foci identified during the repeat ablation procedure were reported.</description>
        <time_frame>Up to 20 months</time_frame>
        <population>The PP analysis set included participants who satisfied the following criteria: a) enrolled and meet eligibility criteria, b) had undergone RF ablation, c) were treated with the study catheters, and d) were treated for the study related arrhythmia, without major protocol deviations that deemed to affect the scientific integrity of the study. Here 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Main Arm: QDOT Micro Catheter</title>
            <description>Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and radiofrequency (RF) ablation using QDOT Micro Catheter for pulmonary vein isolation with nMARQ radiofrequency (RF) generator.</description>
          </group>
          <group group_id="O2">
            <title>Variable Flow Arm: QDOT Micro Catheter</title>
            <description>Participants with symptomatic PAF who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and RF ablation using QDOT Micro Catheter for variable flow with nMARQ RF generator.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Requiring New Linear Lesion and/or New Foci Identified During the Repeat Ablation Procedure</title>
          <description>Percentage of participants requiring new linear lesion and/or new foci identified during the repeat ablation procedure were reported.</description>
          <population>The PP analysis set included participants who satisfied the following criteria: a) enrolled and meet eligibility criteria, b) had undergone RF ablation, c) were treated with the study catheters, and d) were treated for the study related arrhythmia, without major protocol deviations that deemed to affect the scientific integrity of the study. Here 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0"/>
                    <measurement group_id="O2" value="63.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With 12-Month Single Procedure Success</title>
        <description>Percentage of participants with 12-month single procedure success were reported. The 12-month single procedure success is defined as freedom from documented AF/AFL/AT recurrence (episodes &gt; 30 seconds) during the evaluation period after a single ablation procedure.</description>
        <time_frame>Up to 12 months</time_frame>
        <population>The PP analysis set included participants who satisfied the following criteria: a) enrolled and meet eligibility criteria, b) had undergone RF ablation, c) were treated with the study catheters, and d) were treated for the study related arrhythmia, without major protocol deviations that deemed to affect the scientific integrity of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Main Arm: QDOT Micro Catheter</title>
            <description>Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and radiofrequency (RF) ablation using QDOT Micro Catheter for pulmonary vein isolation with nMARQ radiofrequency (RF) generator.</description>
          </group>
          <group group_id="O2">
            <title>Variable Flow Arm: QDOT Micro Catheter</title>
            <description>Participants with symptomatic PAF who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and RF ablation using QDOT Micro Catheter for variable flow with nMARQ RF generator.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With 12-Month Single Procedure Success</title>
          <description>Percentage of participants with 12-month single procedure success were reported. The 12-month single procedure success is defined as freedom from documented AF/AFL/AT recurrence (episodes &gt; 30 seconds) during the evaluation period after a single ablation procedure.</description>
          <population>The PP analysis set included participants who satisfied the following criteria: a) enrolled and meet eligibility criteria, b) had undergone RF ablation, c) were treated with the study catheters, and d) were treated for the study related arrhythmia, without major protocol deviations that deemed to affect the scientific integrity of the study.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="166"/>
                <count group_id="O2" value="82"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.3"/>
                    <measurement group_id="O2" value="72.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 20 months</time_frame>
      <desc>The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.</desc>
      <group_list>
        <group group_id="E1">
          <title>Main Arm: QDOT Micro Catheter</title>
          <description>Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and radiofrequency (RF) ablation using QDOT Micro Catheter for pulmonary vein isolation with nMARQ radiofrequency (RF) generator.</description>
        </group>
        <group group_id="E2">
          <title>Variable Flow Arm: QDOT Micro Catheter</title>
          <description>Participants with symptomatic PAF who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and RF ablation using QDOT Micro Catheter for variable flow with nMARQ RF generator.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="32" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="16" subjects_affected="14" subjects_at_risk="177"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="177"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Cardiac tamponade</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Sinus node dysfunction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Pericardial effusion</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Atrial tachycardia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Atrioventricular block</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Ventricular extrasystoles</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Aortic valve calcification</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Cardiovascular disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Gastrointestinal hemorrhage</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Hiatus hernia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Retroperitoneal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Cyst</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abscess</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Corona virus infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Vascular pseudoaneurysm</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthropathy</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Bursitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Cardiac valve fibroelastoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Prostate cancer</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="177"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Transient ischemic attack</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Haemorrhagic stroke</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pleuritic pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Arteriovenous fistula</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Aortic dilatation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Peripheral vascular disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="58" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac Tamponade/Perforation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Pericardial effusion</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="177"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Pericarditis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Atrial tachycardia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="177"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="177"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Sinus bradycardia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Sinus tachycardia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Supraventricular extrasystoles</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="177"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="177"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Ventricular arrhythmia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Ventricular extrasystoles</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="177"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Ventricular tachycardia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Non-Cardiac Chest pain</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Peripheral swelling</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Incision site hemorrhage</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Urinary tract injury</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Anaesthetic complication</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Procedural haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Laboratory test abnormal</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Heart rate increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Fluid overload</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Groin pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Joint swelling</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Neck Pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Phrenic Nerve Injury / Diaphragmatic Paralysis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Hypoesthesia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Carotid artery stenosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Hematuria</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="177"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Prostatitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Vaginal hemorrhage</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pulmonary Edema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Pleuritic pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Pulmonary vein stenosis</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Major Vascular Access Complication / Bleeding</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Hematoma</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" events="10" subjects_affected="8" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="177"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Publications and presentation of clinical investigation results will be coordinated between sponsor and the clinical investigation authors. Authorship to be determined prior to development of any manuscript. All information concerning the study, investigational medical device, sponsor operations, patent application, manufacturing processes and basic scientific data supplied by the sponsor to the investigator and not previously published, are confidential and remain sole property of the sponsor.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Franchise Medical Manager</name_or_title>
      <organization>Biosense Webster, Inc.</organization>
      <phone>844-434-4210</phone>
      <email>ClinicalTrialDisclosure@its.jnj.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03775512
org study id: BWI_2017_07
nct id: NCT03775512
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
Prospective, non-randomized, pre-market clinical evaluation of the QDOT MICRO™ Catheter to
      demonstrate the safety and effectiveness when compared to an historical control performance
      goal.
Prospective, non-randomized, pre-market clinical evaluation of the QDOT MICRO™ Catheter to
      demonstrate the safety and effectiveness when compared to an historical control performance
      goal.

      the trial has two arms: main arm and second arm (variable flow). The main arm will enroll 185
      subjects and second arm will enroll 92 subjects.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants With Early Onset Primary Adverse Events (PAEs): Atrio-esophageal Fistula and Pulmonary Vein (PV) Stenosis
time frame: Up to 90 days (post initial and repeated ablation procedure)
description: An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. A Primary AEs is an event which occurred within 90 days following initial and repeated ablation procedure using the QDOT MICRO. Primary AEs included: atrio-esophageal fistula and pulmonary vein stenosis.
measure: Percentage of Participants With Early Onset PAEs: Death, Myocardial Infraction, Cardiac Tamponade/Perforation, Thromboembolism, Stroke/Cardiovascular Accident , TIA, PNP, Heart Block, Pulmonary Edema, Vagal Nerve Injury, Pericarditis, and MVAC/Bleeding
time frame: Up to 7 days (post initial and repeated ablation procedure)
description: A Primary AEs is an event which occurred within the first week (7 days of the initial and repeated ablation procedure) which included death, myocardial infraction (MI), cardiac tamponade (CT)/perforation, thromboembolism, stroke/cardiovascular accident (CVA), transient ischemic attack (TIA), phrenic nerve paralysis (PNP), heart block, pulmonary edema, vagal nerve injury, pericarditis, and major vascular access complication/bleeding (MVAC).
measure: Percentage of Participants With Freedom From Documented Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes or Other Failure Modes
time frame: Day 91 to Day 365
description: Percentage of participants with freedom from documented AF, AT, or AFL episodes or following failure modes: a) Acute procedural: Failure to confirm entrance block in all pulmonary veins post-procedure and use of a non-study catheter to treat left atrial ablation targets and Cavo-tricuspid isthmus; b) Repeat ablation: >2 repeat ablation procedures with the study catheter during the 3-Month blanking period (Day 0-90) after the index ablation procedure, use of a non-study catheter to treat study arrhythmia ablation targets during the blanking period, and any repeat ablation procedure during the Evaluation Period; c) Antiarrhythmic drug: taking a new AAD for AF or a previously failed AAD at a greater than the highest ineffective historical dose for AF during the evaluation period, were reported.
measure: Number of Participants With Unanticipated Adverse Device Effects (UADEs)
time frame: Up to 20 months
description: Number of participants with UADEs were reported.
measure: Number of Participants With Serious Non-Primary Adverse Events (SAEs) Within 7 Days (Early Onset), 8-30 Days (Peri-procedural) and Greater Than or Equal to (>=) 31 Days (Late Onset) of Initial Ablation Procedure
time frame: Within 7 days (early onset), 8-30 days (peri-procedural) and >=31 days (late onset) of initial ablation procedure (up to 20 months)
description: Number of participants with serious non-primary AEs within 7 days (early onset), 8-30 days (peri-procedural) and >=31 days (late onset) of initial ablation were reported.
measure: Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset
time frame: Within 7 days (early onset), 8-30 days (peri-procedural) and >=31 days (late onset) of initial ablation procedure (up to 20 months)
description: Number of participants with bleeding complication (ISTH definitions): a) major, b) clinically relevant non-major and c) minor bleeding were reported. The ISTH classification of major bleeding event is a hemoglobin drop of greater than or equal to (>=) 2 grams per deciliter (g/dL), transfusion of >= 2 units (U) packed red blood cells, symptomatic bleed in a critical area, or fatal bleed. Clinically relevant non-major (CRNM) events require prolong hospitalization or result in laboratory testing, imaging, compression, procedure, interruption of the study medication or a change in concomitant therapy. Minor bleeding events are overt bleeding events that do not meet the criteria for CRNM or major bleeding events.
measure: Percentage of Participants With Electrical Isolation of Pulmonary Veins (PVs) (Entrance Block) at the End of the Procedure
time frame: End of the Procedure (up to 20 months)
description: Percentage of participants with electrical isolation of PVs (entrance block) at the end of the procedure were reported
measure: Percentage of Participants With Electrical Isolation of PV After First Encirclement With Acute Reconnection
time frame: Up to 20 months
description: Percentage of participants with electrical isolation of PV after first encirclement with acute reconnection were reported.
measure: Percentage of Participants With Electrical Isolation of PV After First Encirclement Without Acute Reconnection
time frame: Up to 20 months
description: Percentage of participants with electrical isolation of PV after first encirclement without acute reconnection were reported.
measure: Percentage of Participants With Pulmonary Veins (PV) Touch-up
time frame: Up to 20 months
description: Percentage of participants with PV touch-up were reported. PV touch-up was defined as additional ablations being performed after first encirclement for targeted veins with acute reconnection.
measure: Percentage of Targeted Veins With Touch-up (Ablation of Acute Reconnection) Among All Targeted Veins
time frame: Up to 20 months
description: Percentage of targeted veins with touch-up (ablation of acute reconnection) among all targeted veins were reported.
measure: Percentage of Participants With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement
time frame: Up to 20 months
description: Percentage of participants with touch-up at anatomical location of acute PV reconnection after first encirclement was reported. The location included anterior, superior, ridge, posterior, and inferior region of the left pulmonary veins (LPV) and right pulmonary veins (RPV). The review of all ablation targets for the 1 participant with RPV ridge entered by site resulted in reclassification to RPV superior. This outcome measure was planned to be analyzed for specified arm (main arm) only.
measure: Percentage of Participants Who Underwent Repeat Ablation Procedures
time frame: Up to 20 months
description: Percentage of participants who underwent repeat ablation procedures were reported.
measure: Percentage of Participants With PVs Re-isolation Among All of the Targeted PVs at Repeat Procedure
time frame: Up to 20 months
description: Percentage of participants with PVs re-isolation among all of the targeted PVs at repeat procedure were reported.
measure: Percentage of Participants Requiring New Linear Lesion and/or New Foci Identified During the Repeat Ablation Procedure
time frame: Up to 20 months
description: Percentage of participants requiring new linear lesion and/or new foci identified during the repeat ablation procedure were reported.
measure: Percentage of Participants With 12-Month Single Procedure Success
time frame: Up to 12 months
description: Percentage of participants with 12-month single procedure success were reported. The 12-month single procedure success is defined as freedom from documented AF/AFL/AT recurrence (episodes > 30 seconds) during the evaluation period after a single ablation procedure.
arm group label: Main Arm
arm group type: Experimental
description: Subjects will be ablated with the QDOT Micro Catheter for Pulmonary Vein Isolation with nMARQ RF Generator
arm group label: Second Arm (variable flow)
arm group type: Experimental
description: subjects will be treated with QDOT Micro catheter with variable flow nMARQ RF generator
intervention type: Device
intervention name: RF Ablation with QDOT Micro
description: Subjects will be ablated using QDOT Micro catheter
arm group label: Main Arm
arm group label: Second Arm (variable flow)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Emile Daoud
role: Principal Investigator
affiliation: Ohio State University
last name: Jose Osorio
role: Principal Investigator
affiliation: Grandview Medical Center
last name: Francis Marchlinksi
role: Principal Investigator
affiliation: University of Pennsylvania Health System
last name: Michael Cutler
role: Principal Investigator
affiliation: Intermountain Medical Center
last name: Andrea Natale
role: Principal Investigator
affiliation: Texas Cardiac Arrhythmia Research Foundation
last name: Daniel Melby
role: Principal Investigator
affiliation: Abbott Northwestern
last name: Miguel Valderabanno
role: Principal Investigator
affiliation: The Methodist Hospital Research Institute
last name: George Monir
role: Principal Investigator
affiliation: AdventHealth
last name: Craig Delaughter
role: Principal Investigator
affiliation: Texas Heart Health and Vascular
last name: Christopher Liu
role: Principal Investigator
affiliation: New York Presbyterian Hospital
last name: Saumil Oza
role: Principal Investigator
affiliation: Ascension St. Vincent's
last name: Ayman Hussein
role: Principal Investigator
affiliation: The Cleveland Clinic
last name: Robert Fishel
role: Principal Investigator
affiliation: JFK Hospital
last name: Kenneth Ellenbogen
role: Principal Investigator
affiliation: VCU
last name: Gery Tomassoni
role: Principal Investigator
affiliation: Baptist Hospital
last name: Tristram Bahnson
role: Principal Investigator
affiliation: Duke University
last name: Chris Ellis
role: Principal Investigator
affiliation: VUMC
last name: Emerson Liu
role: Principal Investigator
affiliation: Allegheny College
last name: David Wilber
role: Principal Investigator
affiliation: Loyola University
last name: Moussa Mansour
role: Principal Investigator
affiliation: Mass. General Hospital
last name: Srinivas Dukkipati
role: Principal Investigator
affiliation: Icahn School of Medicine at Mount Sinai
last name: Hugh McElderry
role: Principal Investigator
affiliation: University of Alabama at Birmingham
last name: Ashish Patel
role: Principal Investigator
affiliation: Wakemed Heart and Vascular
last name: Larry Chinitz
role: Principal Investigator
affiliation: NYU Langone Medical Center
last name: Luigi DiBiase
role: Principal Investigator
affiliation: Montefiore
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Atrial Fibrillation
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 