xml: <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/NCT05971693</url>
    </required_header>
    <id_info>
      <org_study_id>BWI202201</org_study_id>
      <secondary_id>BWI202201</secondary_id>
      <nct_id>NCT05971693</nct_id>
    </id_info>
    <brief_title>A Study For Treatment of Paroxysmal Atrial Fibrillation (PAF) With the OMNYPULSE Catheter and the TRUPULSE Generator</brief_title>
    <acronym>Omny-IRE</acronym>
    <official_title>Safety and Effectiveness Evaluation of the OMNYPULSE Catheter With the TRUPULSE Generator for Treatment of Paroxysmal Atrial Fibrillation (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>
      <has_dmc>Yes</has_dmc>
      <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>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to demonstrate safety and effectiveness of the ablation system&#xD;
        (OMNYPULSE Bi-directional catheter and TRUPULSE generator) when used for isolation of the&#xD;
        atrial pulmonary veins (PVs) in treatment of participants with paroxysmal atrial fibrillation&#xD;
        (PAF).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 28, 2023</start_date>
    <completion_date type="Anticipated">April 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">April 30, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of Participants with Primary Adverse Events (PAE's)</measure>
      <time_frame>7 days post-ablation procedure on Day 0 (up to Day 7)</time_frame>
      <description>Number of Participants with incidence of PAEs (within 7 days following the ablation procedure) will be reported. PAE's will include the following adverse events atrio-esophageal fistula, phrenic nerve paralysis, cardiac tamponade/perforation, pulmonary vein stenosis, device or procedure related death, stroke/cerebrovascular accident (CVA), major vascular access complication/bleeding, thromboembolism, myocardial infarction, transient ischemic attack (TIA), pericarditis, heart block, pulmonary edema (respiratory insufficiency) and vagal nerve injury/gastroparesis.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Percentage of Participants with Acute Effectiveness</measure>
      <time_frame>Immediate post-procedure</time_frame>
      <description>Percentage of participants with acute effectiveness will be reported. Acute effectiveness is an electrical isolation of clinically relevant targeted pulmonary veins (PVs) (confirmed by entrance block) after adenosine/isoproterenol challenge at the end of the index ablation procedure. Use of a non-study device to achieve PV isolation is considered an acute procedural failure.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>12-month Effectiveness: Number of Participants who Achieved Freedom from Documented Atrial Arrhythmia Episodes During the Effectiveness Evaluation period (AF, AT or AFL of Unknown Origin) within Day 91 to Day 365 Post Index Procedure</measure>
      <time_frame>Within Day 91 to Day 365 post-ablation procedure (on Day 1)</time_frame>
      <description>12-month effectiveness: Number of participants rate of Freedom from documented (symptomatic and asymptomatic) Atrial Arrhythmia (Atrial Fibrillation [AF], Atrial Tachycardia [AT] or Atrial Flutter [AFL] of unknown origin) episodes assessed during the effectiveness evaluation period (Day 91 to Day 365 days post index procedure will be reported. Freedom from atrial arrhythmia will be reported based on electrocardiographic data (greater than or equal to [&gt;=30] seconds on arrhythmia monitoring device) during the effectiveness evaluation period on or off antiarrhythmic therapy. Acute procedural failure (that is, failure to achieve entrance block with the study device in any of the clinically relevant targeted PVs) will also be deemed a 12- month effectiveness failure.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">160</enrollment>
    <condition>Atrial Fibrillation</condition>
    <arm_group>
      <arm_group_label>OMNYPULSE Bi-Directional Catheter with TRUPULSE Generator</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants with symptomatic paroxysmal atrial fibrillation (PAF) will undergo the ablation procedure with OMNYPULSE bi-directional catheter used in combination with the TRUPULSE generator for pulmonary vein isolation (PVI).</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>OMNYPULSE Bi-Directional Catheter with TRUPULSE Generator</intervention_name>
      <description>Participants will undergo catheter ablation with the PF ablation system consisting of the TRUPULSE generator (delivers PF energy through the study catheter) and the OMNYPULSE bi-directional catheter (indicated for use in catheter-based cardiac electrophysiological mapping [stimulating and recording] and, when used with a Generator, for cardiac ablation).</description>
      <arm_group_label>OMNYPULSE Bi-Directional Catheter with TRUPULSE Generator</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnosed with Symptomatic paroxysmal atrial fibrillation (PAF) defined as as atrial&#xD;
               fibrillation (AF) that terminates spontaneously or with intervention within 7 days of&#xD;
               onset. This PAF is considered to be symptomatic if symptoms related to AF are&#xD;
               experienced by the participant&#xD;
  &#xD;
            -  Selected for AF ablation procedure by pulmonary vein isolation (PVI)&#xD;
  &#xD;
            -  Willing and capable of providing consent&#xD;
  &#xD;
            -  Able and willing to comply with all pre-, post- and follow-up testing and requirements&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Previously known AF secondary to electrolyte imbalance, thyroid disease, or reversible&#xD;
               or non-cardiac cause (example, documented obstructive sleep apnea, acute alcohol&#xD;
               toxicity, morbid obesity [body mass index greater than {&gt;} 40 kilograms per meter&#xD;
               square {kg/m^2}]), renal insufficiency (with an estimated creatinine clearance less&#xD;
               than (&lt;) 30 milliliters per minute per 1.73 meter square [mL/min/1.73 m^2])&#xD;
  &#xD;
            -  Previous left atrium (LA) ablation or surgery&#xD;
  &#xD;
            -  Participants known to require ablation outside the PV region (example,&#xD;
               atrioventricular reentrant tachycardia, atrioventricular nodal re-entry tachycardia,&#xD;
               atrial tachycardia, ventricular tachycardia and Wolff-Parkinson-White)&#xD;
  &#xD;
            -  Previously diagnosed with persistent AF (&gt; 7 days in duration)&#xD;
  &#xD;
            -  Severe dilatation of the left atrium (LA) (left anterior descending artery [LAD] &gt;50&#xD;
               millimeter [mm] antero-posterior diameter in case of transthoracic echocardiography&#xD;
               [TTE])&#xD;
  &#xD;
            -  Presence of LA thrombus&#xD;
  &#xD;
            -  Severely compromised left ventricular ejection fraction (left ventricular ejection&#xD;
               fraction [LVEF] &lt;40 percentage [%])&#xD;
  &#xD;
            -  Uncontrolled heart failure or New York Heart Association (NYHA) Class III or IV&#xD;
  &#xD;
            -  History of blood clotting, bleeding abnormalities or contraindication to&#xD;
               anticoagulation (heparin, warfarin, or dabigatran)&#xD;
  &#xD;
            -  History of a documented thromboembolic event (including transient ischemic attack&#xD;
               [TIA]) within the past 6 months&#xD;
  &#xD;
            -  Previous percutaneous coronary intervention (PCI) / myocardial infarction (MI) within&#xD;
               the past 2 months&#xD;
  &#xD;
            -  Previous coronary artery bypass grafting (CABG) in conjunction with valvular surgery,&#xD;
               cardiac surgery (example, ventriculotomy, atriotomy) or valvular cardiac (surgical or&#xD;
               percutaneous) procedure&#xD;
  &#xD;
            -  Unstable angina pectoris within the past 6 months&#xD;
  &#xD;
            -  Anticipated cardiac transplantation, cardiac surgery, or other major surgery within&#xD;
               the next 12 months&#xD;
  &#xD;
            -  Significant pulmonary disease (example, restrictive pulmonary disease, constrictive or&#xD;
               chronic obstructive pulmonary disease) or any other disease or malfunction of the&#xD;
               lungs or respiratory system that produces severe chronic symptoms&#xD;
  &#xD;
            -  Known significant pulmonary vein (PV) anomaly that in the opinion of the investigator&#xD;
               would preclude enrollment in this study&#xD;
  &#xD;
            -  Prior diagnosis of pulmonary vein stenosis&#xD;
  &#xD;
            -  Pre-existing hemi diaphragmatic paralysis&#xD;
  &#xD;
            -  Acute illness, active systemic infection, or sepsis&#xD;
  &#xD;
            -  Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other&#xD;
               abnormality that precludes catheter introduction or manipulation&#xD;
  &#xD;
            -  Severe mitral regurgitation&#xD;
  &#xD;
            -  Presence of implanted pacemaker or implantable cardioverter-defibrillator (ICD) or&#xD;
               other implanted metal cardiac device that may interfere with the pulsed electric field&#xD;
               energy&#xD;
  &#xD;
            -  Presence of a condition that precludes vascular access (such as Inferior Vena Cava&#xD;
               [IVC] filter)&#xD;
  &#xD;
            -  Significant congenital anomaly or a medical problem that in the opinion of the&#xD;
               investigator would preclude enrollment in this study&#xD;
  &#xD;
            -  Categorized as vulnerable population and requires special treatment with respect to&#xD;
               safeguards of well-being&#xD;
  &#xD;
            -  Current enrollment in an investigational study evaluating another device or drug&#xD;
  &#xD;
            -  Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating,&#xD;
               or who are of child-bearing age and plan on becoming pregnant during the course of the&#xD;
               clinical investigation&#xD;
  &#xD;
            -  Life expectancy less than 12 months&#xD;
  &#xD;
            -  Presenting contra-indications for the devices used in the study, as indicated in the&#xD;
               respective Instructions For Use (IFU)&#xD;
  &#xD;
            -  Known contraindication for magnetic resonance imaging (MRI) such as use of contrast&#xD;
               agents due to advanced renal disease, claustrophobia etcetra. (at principle&#xD;
               investigator [PI] discretion)&#xD;
  &#xD;
            -  Presence of iron-containing metal fragments in the body&#xD;
  &#xD;
            -  Known unresolved pre-existing neurological deficit&#xD;
  &#xD;
            -  Known uncontrolled significant gastroesophageal reflux disease (GERD)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Biosense Webster, Inc., a division of Johnson &amp; Johnson Clinical Trial</last_name>
      <role>Study Director</role>
      <affiliation>Biosense Webster, Inc., a division of Johnson &amp; Johnson</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Study Contact</last_name>
      <phone>+32 479 97 05 05</phone>
      <email>nmacours1@its.jnj.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>O.L.V. Ziekenhuis</name>
        <address>
          <city>Aalst</city>
          <zip>9300</zip>
          <country>Belgium</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>AZ Sint-Jan</name>
        <address>
          <city>Brugge</city>
          <zip>8000</zip>
          <country>Belgium</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Ziekenhuis Oost-Limburg</name>
        <address>
          <city>Genk</city>
          <zip>3600</zip>
          <country>Belgium</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Jessa Ziekenhuis - Campus Virga Jesse</name>
        <address>
          <city>Hasselt</city>
          <zip>3500</zip>
          <country>Belgium</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Montreal Heart Institute</name>
        <address>
          <city>Montreal</city>
          <state>Quebec</state>
          <zip>H1T 1C8</zip>
          <country>Canada</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>McGill University Health Centre</name>
        <address>
          <city>Montreal</city>
          <state>Quebec</state>
          <zip>H3G 1A4</zip>
          <country>Canada</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>KBC Split</name>
        <address>
          <city>Split</city>
          <zip>21000</zip>
          <country>Croatia</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>IKEM</name>
        <address>
          <city>Prague</city>
          <zip>140 21</zip>
          <country>Czechia</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Nemocnice na Homolce</name>
        <address>
          <city>Prague</city>
          <zip>150 30 District 5</zip>
          <country>Czechia</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Generale Regionale F. Miulli</name>
        <address>
          <city>Acquaviva delle Fonti</city>
          <zip>70021</zip>
          <country>Italy</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Vilnius University</name>
        <address>
          <city>Vilnius</city>
          <zip>08661</zip>
          <country>Lithuania</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Maastricht UMC+</name>
        <address>
          <city>Maastricht</city>
          <zip>6229 HX</zip>
          <country>Netherlands</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Luzerner Kantonsspital</name>
        <address>
          <city>Luzern 16</city>
          <zip>6000</zip>
          <country>Switzerland</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Belgium</country>
      <country>Canada</country>
      <country>Croatia</country>
      <country>Czechia</country>
      <country>Italy</country>
      <country>Lithuania</country>
      <country>Netherlands</country>
      <country>Switzerland</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 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>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) project site at yoda.yale.edu</ipd_description>
      <ipd_url>https://www.janssen.com/clinical-trials/transparency</ipd_url>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05971693
  org study id: BWI202201
  secondary id: BWI202201
  nct id: NCT05971693
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  is us export: Yes
  The purpose of this study is to demonstrate safety and effectiveness of the ablation system
        (OMNYPULSE Bi-directional catheter and TRUPULSE generator) when used for isolation of the
        atrial pulmonary veins (PVs) in treatment of participants with paroxysmal atrial fibrillation
        (PAF).
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Number of Participants with Primary Adverse Events (PAE's)
  time frame: 7 days post-ablation procedure on Day 0 (up to Day 7)
  description: Number of Participants with incidence of PAEs (within 7 days following the ablation procedure) will be reported. PAE's will include the following adverse events atrio-esophageal fistula, phrenic nerve paralysis, cardiac tamponade/perforation, pulmonary vein stenosis, device or procedure related death, stroke/cerebrovascular accident (CVA), major vascular access complication/bleeding, thromboembolism, myocardial infarction, transient ischemic attack (TIA), pericarditis, heart block, pulmonary edema (respiratory insufficiency) and vagal nerve injury/gastroparesis.
  measure: Percentage of Participants with Acute Effectiveness
  time frame: Immediate post-procedure
  description: Percentage of participants with acute effectiveness will be reported. Acute effectiveness is an electrical isolation of clinically relevant targeted pulmonary veins (PVs) (confirmed by entrance block) after adenosine/isoproterenol challenge at the end of the index ablation procedure. Use of a non-study device to achieve PV isolation is considered an acute procedural failure.
  measure: 12-month Effectiveness: Number of Participants who Achieved Freedom from Documented Atrial Arrhythmia Episodes During the Effectiveness Evaluation period (AF, AT or AFL of Unknown Origin) within Day 91 to Day 365 Post Index Procedure
  time frame: Within Day 91 to Day 365 post-ablation procedure (on Day 1)
  description: 12-month effectiveness: Number of participants rate of Freedom from documented (symptomatic and asymptomatic) Atrial Arrhythmia (Atrial Fibrillation [AF], Atrial Tachycardia [AT] or Atrial Flutter [AFL] of unknown origin) episodes assessed during the effectiveness evaluation period (Day 91 to Day 365 days post index procedure will be reported. Freedom from atrial arrhythmia will be reported based on electrocardiographic data (greater than or equal to [>=30] seconds on arrhythmia monitoring device) during the effectiveness evaluation period on or off antiarrhythmic therapy. Acute procedural failure (that is, failure to achieve entrance block with the study device in any of the clinically relevant targeted PVs) will also be deemed a 12- month effectiveness failure.
  arm group label: OMNYPULSE Bi-Directional Catheter with TRUPULSE Generator
  arm group type: Experimental
  description: Participants with symptomatic paroxysmal atrial fibrillation (PAF) will undergo the ablation procedure with OMNYPULSE bi-directional catheter used in combination with the TRUPULSE generator for pulmonary vein isolation (PVI).
  intervention type: Device
  intervention name: OMNYPULSE Bi-Directional Catheter with TRUPULSE Generator
  description: Participants will undergo catheter ablation with the PF ablation system consisting of the TRUPULSE generator (delivers PF energy through the study catheter) and the OMNYPULSE bi-directional catheter (indicated for use in catheter-based cardiac electrophysiological mapping [stimulating and recording] and, when used with a Generator, for cardiac ablation).
  arm group label: OMNYPULSE Bi-Directional Catheter with TRUPULSE Generator
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Biosense Webster, Inc., a division of Johnson & Johnson Clinical Trial
  role: Study Director
  affiliation: Biosense Webster, Inc., a division of Johnson & Johnson
  last name: Study Contact
  phone: +32 479 97 05 05
  email: nmacours1@its.jnj.com
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  country: Belgium
  country: Canada
  country: Croatia
  country: Czechia
  country: Italy
  country: Lithuania
  country: Netherlands
  country: Switzerland
  responsible party type: Sponsor
  mesh term: Atrial Fibrillation
  sharing ipd: Yes
  ipd description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) project site at yoda.yale.edu
  ipd url: https://www.janssen.com/clinical-trials/transparency