<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/NCT03012841</url>
  </required_header>
  <id_info>
    <org_study_id>STOP Persistent AF</org_study_id>
    <nct_id>NCT03012841</nct_id>
  </id_info>
  <brief_title>STOP Persistent AF</brief_title>
  <official_title>STOP Persistent AF</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medtronic Cardiac Rhythm and Heart Failure</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medtronic Cardiac Rhythm and Heart Failure</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To demonstrate safety and effectiveness of the Arctic Front Advance™ and Freezor MAX® Cardiac&#xD;
      CryoAblation Catheters for the treatment of drug refractory recurrent symptomatic persistent&#xD;
      atrial fibrillation (AF).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2, 2017</start_date>
  <completion_date type="Actual">August 13, 2019</completion_date>
  <primary_completion_date type="Actual">August 13, 2019</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>
    <intervention_model_description>Arctic Front Advance Cardiac CryoAblation Catheter and Freezor MAX Cardiac CryoAblation Catheter</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent of Subjects Free From Treatment Failure at 12 Months After the Pulmonary Vein Isolation (PVI) Ablation Procedure.</measure>
    <time_frame>12 Months</time_frame>
    <description>Treatment failure is defined as any of the following components:&#xD;
Acute procedural failure&#xD;
Documented AF/atrial tachycardia (AT)/atrial flutter (AFL) after the 90 day blanking period&#xD;
A reablation for the treatment of recurrent AF/AT/AFL after the 90 day blanking period&#xD;
Class I or III antiarrhythmic drug (AAD) dose increase from the historic maximum ineffective dose (prior to the ablation procedure) or initiation of a new Class I or III AAD after the 90 day blanking period.&#xD;
Ablation using radiofrequency (RF) in the left atrium&#xD;
Blanking period is defined as the first 90 days after the index ablation procedure.&#xD;
Acute procedural failure is defined as:&#xD;
Inability to isolate all accessible targeted pulmonary veins (minimally assessed for entrance block and, where assessable, exit block) during the index procedure&#xD;
Left atrial non-PVI ablations including but not limited to, ablation of linear lesions complex fractionated electrograms or non-PV triggers</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent of Subjects Free From a Primary Safety Event at 12 Months After the Pulmonary Vein Isolation (PVI) Ablation Procedure.</measure>
    <time_frame>12 months</time_frame>
    <description>A primary safety event is defined as a serious procedure-related or serious system-related adverse event including the following:&#xD;
Transient ischemic attack (within 7 days of ablation procedure)&#xD;
Cerebrovascular accident (within 7 days of ablation procedure)&#xD;
Major bleeding that requires transfusion (within 7 days of ablation procedure)&#xD;
Cardiac perforation, tamponade or pericardial effusion (within 7 days of ablation procedure)&#xD;
Pulmonary vein stenosis (&gt; 75% reduction within 12-months of ablation procedure)&#xD;
Myocardial infarction (within 7 days of ablation procedure)&#xD;
Phrenic nerve injury (unresolved at 12-months)&#xD;
Atrio-esophageal fistula (within 12-months of ablation procedure)&#xD;
Death (within 7 days of ablation procedure)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of Life Between Baseline and 12 Months: Atrial Fibrillation Effect on QualiTy-of-life (AFEQT)</measure>
    <time_frame>Baseline and 12 months</time_frame>
    <description>Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) questionnaire completed at baseline and 12 month visits. The AFEQT instrument yields scores from 0 (representing the worst possible debilitation from AF) to 100 (representing no reduction in quality of life from AF).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of Life Between Baseline and 12 Months: Medical Outcome Study Short Form-12 (SF-12) Physical Component</measure>
    <time_frame>Baseline and 12 months</time_frame>
    <description>Medical Outcome Study Short Form-12 (SF-12) questionnaire completed at baseline and 12 month visits. The SF-12 instrument has two composite scores, one for physical health and one for mental health. Each yields scores from 0 (representing the worst possible debilitation) to 100 (representing no reduction in quality of life).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of Life Between Baseline and 12 Months: Medical Outcome Study Short Form-12 (SF-12) Mental Component</measure>
    <time_frame>Baseline and 12 months</time_frame>
    <description>Medical Outcome Study Short Form-12 (SF-12) questionnaire completed at baseline and 12 month visits. The SF-12 instrument has two composite scores, one for physical health and one for mental health. Each yields scores from 0 (representing the worst possible debilitation) to 100 (representing no reduction in quality of life).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">186</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Treatment Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects enrolled and treated with Arctic Front Advance Cardiac CryoAblation Catheter</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Arctic Front Advance Cardiac CryoAblation Catheter</intervention_name>
    <description>Cryoablation</description>
    <arm_group_label>Treatment Arm</arm_group_label>
    <other_name>Freezor MAX Cardiac CryoAblation Catheter</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Documentation of symptomatic persistent AF: Defined as having a continuous episode&#xD;
             lasting longer than 7 days but less than 6 months documented by consecutive ECG&#xD;
             recordings OR Defined as having a continuous episode lasting longer than 7 days but&#xD;
             less than 6 months documented by an ECG recording and one doctor note indicating&#xD;
             patient had symptoms consistent with AF&#xD;
&#xD;
          -  Failure or intolerance of at least one Class I or III antiarrhythmic drug&#xD;
&#xD;
          -  Age 18 or older (or older than 18 if required by local law)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Left atrial diameter &gt; 5.0 cm (anteroposterior)&#xD;
&#xD;
          -  Prior left atrial ablation or surgical procedure (including left atrial appendage&#xD;
             closures)&#xD;
&#xD;
          -  Presence or likely implant of a permanent pacemaker, biventricular pacemaker, loop&#xD;
             recorder, or any type of implantable cardiac defibrillator (with or without&#xD;
             biventricular pacing function) within 12 months&#xD;
&#xD;
          -  Presence of any pulmonary vein stents&#xD;
&#xD;
          -  Presence of any pre-existing pulmonary vein stenosis&#xD;
&#xD;
          -  Pre-existing hemidiaphragmatic paralysis&#xD;
&#xD;
          -  Presence of any cardiac valve prosthesis&#xD;
&#xD;
          -  +3 and +4 mitral valve regurgitation or stenosis&#xD;
&#xD;
          -  Any cardiac surgery, myocardial infarction, percutaneous coronary intervention (PCI) /&#xD;
             percutaneous transluminal coronary angioplasty (PTCA) or coronary artery stenting&#xD;
             which occurred during the 3 month interval preceding the consent date&#xD;
&#xD;
          -  Unstable angina&#xD;
&#xD;
          -  New York Heart Association (NYHA) Class III or IV congestive heart failure and/or&#xD;
             documented left ventricular ejection fraction (LVEF) less than or equal to 35% measure&#xD;
             by acceptable cardiac testing (e.g. Transthoracic echocardiogram (TTE))&#xD;
&#xD;
          -  Primary pulmonary hypertension&#xD;
&#xD;
          -  Rheumatic heart disease&#xD;
&#xD;
          -  Thrombocytosis, thrombocytopenia&#xD;
&#xD;
          -  Any condition contraindicating chronic anticoagulation&#xD;
&#xD;
          -  Active systemic infection&#xD;
&#xD;
          -  Hypertrophic cardiomyopathy&#xD;
&#xD;
          -  Cryoglobulinemia&#xD;
&#xD;
          -  Uncontrolled hyperthyroidism&#xD;
&#xD;
          -  Any cerebral ischemic event (strokes or transient ischemic attacks (TIAs)) which&#xD;
             occurred during the 6 month interval preceding the consent date&#xD;
&#xD;
          -  Any woman known to be pregnant or breastfeeding, or any woman of child bearing&#xD;
             potential who is not on a reliable form of birth regulation method or abstinence&#xD;
&#xD;
          -  Life expectancy less than one year&#xD;
&#xD;
          -  Current or anticipated participation in any other clinical trial of a drug, device or&#xD;
             biologic during the duration of the study not pre-approved by Medtronic&#xD;
&#xD;
          -  Known allergies or hypersensitivities to adhesives&#xD;
&#xD;
          -  Known drug or alcohol dependency&#xD;
&#xD;
          -  Unwilling or unable to comply fully with study procedures and follow-up&#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>Hugh Calkins, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Vivek Reddy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Banner-University Medical Center Phoenix</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Colorado Heart and Vascular</name>
      <address>
        <city>Lakewood</city>
        <state>Colorado</state>
        <zip>80228</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center of the Rockies</name>
      <address>
        <city>Loveland</city>
        <state>Colorado</state>
        <zip>80538</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiac Arrhythmia Service</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33432</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Vincent's Medical Center</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NorthShore University Health System</name>
      <address>
        <city>Evanston</city>
        <state>Illinois</state>
        <zip>60201-1718</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Johns Hopkins Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287-0005</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>St. Luke's Health System</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Englewood Hospital &amp; Medical Center</name>
      <address>
        <city>Englewood</city>
        <state>New Jersey</state>
        <zip>07631-1808</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwell Health (Lenox Hill Hospital and Staten Island University Hospital)</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10075-1851</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asheville Cardiology Associates</name>
      <address>
        <city>Asheville</city>
        <state>North Carolina</state>
        <zip>28803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Doylestown Health Cardiology</name>
      <address>
        <city>Doylestown</city>
        <state>Pennsylvania</state>
        <zip>18901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232-8802</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor Research Institute</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Mason Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Victoria Cardiac Arrhythmia Trials</name>
      <address>
        <city>Victoria</city>
        <state>British Columbia</state>
        <zip>V8T 1Z4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>London Health Sciences Centre</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5A5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Universitaire de Cardiologie et de Pneumologie de Québec</name>
      <address>
        <city>Quebec</city>
        <zip>G1V 4G5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokyo Medical and Dental University</name>
      <address>
        <city>Bunkyō</city>
        <state>Tokyo</state>
        <zip>113-8519</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jikei University Hospital</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yokohama City Minato Red Cross Hospital</name>
      <address>
        <city>Yokohama</city>
        <zip>231-8682</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Japan</country>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>December 22, 2016</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <results_first_submitted>August 11, 2020</results_first_submitted>
  <results_first_submitted_qc>August 11, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">August 21, 2020</results_first_posted>
  <last_update_submitted>September 14, 2020</last_update_submitted>
  <last_update_submitted_qc>September 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 8, 2020</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>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <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 8, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/41/NCT03012841/SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol: Version 4</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>November 10, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/41/NCT03012841/Prot_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol: Version 5</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>April 17, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/41/NCT03012841/Prot_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol: Version 6</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>December 1, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/41/NCT03012841/Prot_003.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Modified Intent to Treat (mITT) Group</title>
          <description>Subjects enrolled and treated with Arctic Front Advance Cardiac CryoAblation Catheter</description>
        </group>
        <group group_id="P2">
          <title>Not Treated</title>
          <description>Subjects enrolled, but not treated with an Arctic Front Advance Cryoablation catheter.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="165"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="145"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <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="6"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Unable to complete 12 month visit</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Subject relocation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Seasonal winter travel</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No ablation performed</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study reached n=165 treated subject cap</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Insurance change</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>
      <population>The baseline analysis population includes those subjects who were enrolled and underwent ablation with an Arctic Front Advance CryoAblation catheter.</population>
      <group_list>
        <group group_id="B1">
          <title>Modified Intent to Treat Group (mITT)</title>
          <description>Subjects enrolled and treated with Arctic Front Advance Cardiac CryoAblation Catheter</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="165"/>
          </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="65" spread="9"/>
                  </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="49"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="116"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White or Caucasian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="142"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Japanese</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Filipino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subject/physician chose not to provide</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="120"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Japan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Time from Persistent Atrial Fibrillation (AF) Onset</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.6" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duration of Longest Persistent AF Episode</title>
          <units>days</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60.9" lower_limit="7" upper_limit="182.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percent of Subjects Free From Treatment Failure at 12 Months After the Pulmonary Vein Isolation (PVI) Ablation Procedure.</title>
        <description>Treatment failure is defined as any of the following components:&#xD;
Acute procedural failure&#xD;
Documented AF/atrial tachycardia (AT)/atrial flutter (AFL) after the 90 day blanking period&#xD;
A reablation for the treatment of recurrent AF/AT/AFL after the 90 day blanking period&#xD;
Class I or III antiarrhythmic drug (AAD) dose increase from the historic maximum ineffective dose (prior to the ablation procedure) or initiation of a new Class I or III AAD after the 90 day blanking period.&#xD;
Ablation using radiofrequency (RF) in the left atrium&#xD;
Blanking period is defined as the first 90 days after the index ablation procedure.&#xD;
Acute procedural failure is defined as:&#xD;
Inability to isolate all accessible targeted pulmonary veins (minimally assessed for entrance block and, where assessable, exit block) during the index procedure&#xD;
Left atrial non-PVI ablations including but not limited to, ablation of linear lesions complex fractionated electrograms or non-PV triggers</description>
        <time_frame>12 Months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Modified Intent to Treat Group (mITT)</title>
            <description>Subjects enrolled and treated with Arctic Front Advance Cardiac CryoAblation Catheter</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Subjects Free From Treatment Failure at 12 Months After the Pulmonary Vein Isolation (PVI) Ablation Procedure.</title>
          <description>Treatment failure is defined as any of the following components:&#xD;
Acute procedural failure&#xD;
Documented AF/atrial tachycardia (AT)/atrial flutter (AFL) after the 90 day blanking period&#xD;
A reablation for the treatment of recurrent AF/AT/AFL after the 90 day blanking period&#xD;
Class I or III antiarrhythmic drug (AAD) dose increase from the historic maximum ineffective dose (prior to the ablation procedure) or initiation of a new Class I or III AAD after the 90 day blanking period.&#xD;
Ablation using radiofrequency (RF) in the left atrium&#xD;
Blanking period is defined as the first 90 days after the index ablation procedure.&#xD;
Acute procedural failure is defined as:&#xD;
Inability to isolate all accessible targeted pulmonary veins (minimally assessed for entrance block and, where assessable, exit block) during the index procedure&#xD;
Left atrial non-PVI ablations including but not limited to, ablation of linear lesions complex fractionated electrograms or non-PV triggers</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="165"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.8" lower_limit="46.7" upper_limit="62.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The formal alternative hypothesis test for the primary effectiveness objective was that the Kaplan-Meier estimator of treatment success at 12 months (365 days) was greater than 40%, against the null hypothesis that it was less than or equal to 40%.</non_inferiority_desc>
            <p_value>&lt;0.001</p_value>
            <method>Exact binomial</method>
            <method_desc>Exact binomial p-value is shown, but the confidence intervals reported are calculated from Greenwood's approximation of the standard error.</method_desc>
            <param_type>Kaplan-Meier (product-limit) estimator</param_type>
            <param_value>54.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>46.7</ci_lower_limit>
            <ci_upper_limit>62.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percent of Subjects Free From a Primary Safety Event at 12 Months After the Pulmonary Vein Isolation (PVI) Ablation Procedure.</title>
        <description>A primary safety event is defined as a serious procedure-related or serious system-related adverse event including the following:&#xD;
Transient ischemic attack (within 7 days of ablation procedure)&#xD;
Cerebrovascular accident (within 7 days of ablation procedure)&#xD;
Major bleeding that requires transfusion (within 7 days of ablation procedure)&#xD;
Cardiac perforation, tamponade or pericardial effusion (within 7 days of ablation procedure)&#xD;
Pulmonary vein stenosis (&gt; 75% reduction within 12-months of ablation procedure)&#xD;
Myocardial infarction (within 7 days of ablation procedure)&#xD;
Phrenic nerve injury (unresolved at 12-months)&#xD;
Atrio-esophageal fistula (within 12-months of ablation procedure)&#xD;
Death (within 7 days of ablation procedure)</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Modified Intent to Treat Group (mITT)</title>
            <description>Subjects enrolled and treated with Arctic Front Advance Cardiac CryoAblation Catheter</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Subjects Free From a Primary Safety Event at 12 Months After the Pulmonary Vein Isolation (PVI) Ablation Procedure.</title>
          <description>A primary safety event is defined as a serious procedure-related or serious system-related adverse event including the following:&#xD;
Transient ischemic attack (within 7 days of ablation procedure)&#xD;
Cerebrovascular accident (within 7 days of ablation procedure)&#xD;
Major bleeding that requires transfusion (within 7 days of ablation procedure)&#xD;
Cardiac perforation, tamponade or pericardial effusion (within 7 days of ablation procedure)&#xD;
Pulmonary vein stenosis (&gt; 75% reduction within 12-months of ablation procedure)&#xD;
Myocardial infarction (within 7 days of ablation procedure)&#xD;
Phrenic nerve injury (unresolved at 12-months)&#xD;
Atrio-esophageal fistula (within 12-months of ablation procedure)&#xD;
Death (within 7 days of ablation procedure)</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="165"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" lower_limit="0.1" upper_limit="4.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The formal alternative hypothesis tested for the primary safety objective was that the Kaplan-Meier estimator of the proportion of subjects with primary safety events at 12 months (365 days) was less than 13%, against the null hypothesis that it was greater than or equal to 13%.</non_inferiority_desc>
            <p_value>0.002</p_value>
            <method>Exact binomial</method>
            <method_desc>Exact binomial p-value is shown, but the confidence intervals reported are calculated from Greenwood's approximation of the standard error.</method_desc>
            <param_type>Kaplan-Meier (product-limit) estimator</param_type>
            <param_value>0.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1</ci_lower_limit>
            <ci_upper_limit>4.4</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Quality of Life Between Baseline and 12 Months: Atrial Fibrillation Effect on QualiTy-of-life (AFEQT)</title>
        <description>Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) questionnaire completed at baseline and 12 month visits. The AFEQT instrument yields scores from 0 (representing the worst possible debilitation from AF) to 100 (representing no reduction in quality of life from AF).</description>
        <time_frame>Baseline and 12 months</time_frame>
        <population>Treated subjects completing at least 50% of questions on AFEQT questionnaires at both baseline and 12-month visits</population>
        <group_list>
          <group group_id="O1">
            <title>Treated 12-month Completers</title>
            <description>Subjects enrolled and treated with Arctic Front Advance Cardiac CryoAblation Catheter who had complete QoL questionnaires at baseline and follow-up</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Quality of Life Between Baseline and 12 Months: Atrial Fibrillation Effect on QualiTy-of-life (AFEQT)</title>
          <description>Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) questionnaire completed at baseline and 12 month visits. The AFEQT instrument yields scores from 0 (representing the worst possible debilitation from AF) to 100 (representing no reduction in quality of life from AF).</description>
          <population>Treated subjects completing at least 50% of questions on AFEQT questionnaires at both baseline and 12-month visits</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="141"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.8" lower_limit="22.1" upper_limit="29.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>The formal alternative hypothesis tested was that the mean 12-month change in AFEQT composite scores was greater than 0, against the null the hypothesis that it was equal to 0.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>A Hommel multiple testing procedure was utilized to maintain overall alpha of 0.025 for the 3 hypotheses tested for the secondary objective.</p_value_desc>
            <method>t-test, 1 sided</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>25.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>22.1</ci_lower_limit>
            <ci_upper_limit>29.5</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Quality of Life Between Baseline and 12 Months: Medical Outcome Study Short Form-12 (SF-12) Physical Component</title>
        <description>Medical Outcome Study Short Form-12 (SF-12) questionnaire completed at baseline and 12 month visits. The SF-12 instrument has two composite scores, one for physical health and one for mental health. Each yields scores from 0 (representing the worst possible debilitation) to 100 (representing no reduction in quality of life).</description>
        <time_frame>Baseline and 12 months</time_frame>
        <population>Treated subjects fully completing SF-12 questionnaires at both baseline and 12-month visits</population>
        <group_list>
          <group group_id="O1">
            <title>Treated 12-month Completers</title>
            <description>Subjects enrolled and treated with Arctic Front Advance Cardiac CryoAblation Catheter who had complete QoL questionnaires at baseline and follow-up</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Quality of Life Between Baseline and 12 Months: Medical Outcome Study Short Form-12 (SF-12) Physical Component</title>
          <description>Medical Outcome Study Short Form-12 (SF-12) questionnaire completed at baseline and 12 month visits. The SF-12 instrument has two composite scores, one for physical health and one for mental health. Each yields scores from 0 (representing the worst possible debilitation) to 100 (representing no reduction in quality of life).</description>
          <population>Treated subjects fully completing SF-12 questionnaires at both baseline and 12-month visits</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="142"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" lower_limit="3.5" upper_limit="6.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>The formal alternative hypothesis tested was that the mean 12-month change in SF-12 physical composite scores was greater than 0, against the null the hypothesis that it was equal to 0.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>A Hommel multiple testing procedure was utilized to maintain overall alpha of 0.025 for the 3 hypotheses tested for the secondary objective.</p_value_desc>
            <method>t-test, 1 sided</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>5.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.5</ci_lower_limit>
            <ci_upper_limit>6.5</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Quality of Life Between Baseline and 12 Months: Medical Outcome Study Short Form-12 (SF-12) Mental Component</title>
        <description>Medical Outcome Study Short Form-12 (SF-12) questionnaire completed at baseline and 12 month visits. The SF-12 instrument has two composite scores, one for physical health and one for mental health. Each yields scores from 0 (representing the worst possible debilitation) to 100 (representing no reduction in quality of life).</description>
        <time_frame>Baseline and 12 months</time_frame>
        <population>Treated subjects fully completing SF-12 questionnaires at both baseline and 12-month visits</population>
        <group_list>
          <group group_id="O1">
            <title>Treated 12-month Completers</title>
            <description>Subjects enrolled and treated with Arctic Front Advance Cardiac CryoAblation Catheter who had complete QoL questionnaires at baseline and follow-up</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Quality of Life Between Baseline and 12 Months: Medical Outcome Study Short Form-12 (SF-12) Mental Component</title>
          <description>Medical Outcome Study Short Form-12 (SF-12) questionnaire completed at baseline and 12 month visits. The SF-12 instrument has two composite scores, one for physical health and one for mental health. Each yields scores from 0 (representing the worst possible debilitation) to 100 (representing no reduction in quality of life).</description>
          <population>Treated subjects fully completing SF-12 questionnaires at both baseline and 12-month visits</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="142"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.9" lower_limit="3.2" upper_limit="6.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>The formal alternative hypothesis tested was that the mean 12-month change in SF-12 mental composite scores was greater than 0, against the null the hypothesis that it was equal to 0.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>A Hommel multiple testing procedure was utilized to maintain overall alpha of 0.025 for the 3 hypotheses tested for the secondary objective.</p_value_desc>
            <method>t-test, 1 sided</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>4.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.2</ci_lower_limit>
            <ci_upper_limit>6.6</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All adverse events were collected between subject consent (enrollment) and study completion (1 year post study cryoablation procedure)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Enrolled Subjects</title>
          <description>All enrolled and consented subjects</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (22.0)</default_vocab>
        <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="0" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="34" subjects_at_risk="186"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="186"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="11" subjects_affected="10" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>Atrial tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>Cardiac failure acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>Pericarditis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="186"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Crohn's disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>Odynophagia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="186"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Puncture site haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="186"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis chronic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="186"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bacterial sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>Labyrinthitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="186"/>
              </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="186"/>
              </event>
              <event>
                <sub_title>Postoperative ileus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>Ureteric injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="186"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Fluid retention</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>Hyponatremia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="186"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Neck mass</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="186"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Breast cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>Lung neoplasm malignant</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma of the tongue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="186"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Hemiparesis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="186"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="186"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="186"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic perforation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="186"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (22.0)</default_vocab>
        <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="52" subjects_at_risk="186"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="62" subjects_affected="44" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" events="24" subjects_affected="20" subjects_at_risk="186"/>
              </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>Principle Investigator (PI) agrees they will not independently discuss or publish trial results until a multi-center publication is released. If a multi-center publication is not released within one year after completion of the Study at all Study sites, PIs will have the right to publish the results of and information pertaining to their activities. Any such Publication must be submitted to Medtronic for review and comment at least sixty (60) days prior to submission or presentation.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Mary Sauline, Clinical Research Specialist</name_or_title>
      <organization>Medtronic</organization>
      <phone>440-596-3529</phone>
      <email>mary.k.sauline@medtronic.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/NCT03012841
org study id: STOP Persistent AF
nct id: NCT03012841
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
To demonstrate safety and effectiveness of the Arctic Front Advance™ and Freezor MAX® Cardiac
      CryoAblation Catheters for the treatment of drug refractory recurrent symptomatic persistent
      atrial fibrillation (AF).
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Arctic Front Advance Cardiac CryoAblation Catheter and Freezor MAX Cardiac CryoAblation Catheter
primary purpose: Treatment
masking: None (Open Label)
measure: Percent of Subjects Free From Treatment Failure at 12 Months After the Pulmonary Vein Isolation (PVI) Ablation Procedure.
time frame: 12 Months
description: Treatment failure is defined as any of the following components:
Acute procedural failure
Documented AF/atrial tachycardia (AT)/atrial flutter (AFL) after the 90 day blanking period
A reablation for the treatment of recurrent AF/AT/AFL after the 90 day blanking period
Class I or III antiarrhythmic drug (AAD) dose increase from the historic maximum ineffective dose (prior to the ablation procedure) or initiation of a new Class I or III AAD after the 90 day blanking period.
Ablation using radiofrequency (RF) in the left atrium
Blanking period is defined as the first 90 days after the index ablation procedure.
Acute procedural failure is defined as:
Inability to isolate all accessible targeted pulmonary veins (minimally assessed for entrance block and, where assessable, exit block) during the index procedure
Left atrial non-PVI ablations including but not limited to, ablation of linear lesions complex fractionated electrograms or non-PV triggers
measure: Percent of Subjects Free From a Primary Safety Event at 12 Months After the Pulmonary Vein Isolation (PVI) Ablation Procedure.
time frame: 12 months
description: A primary safety event is defined as a serious procedure-related or serious system-related adverse event including the following:
Transient ischemic attack (within 7 days of ablation procedure)
Cerebrovascular accident (within 7 days of ablation procedure)
Major bleeding that requires transfusion (within 7 days of ablation procedure)
Cardiac perforation, tamponade or pericardial effusion (within 7 days of ablation procedure)
Pulmonary vein stenosis (> 75% reduction within 12-months of ablation procedure)
Myocardial infarction (within 7 days of ablation procedure)
Phrenic nerve injury (unresolved at 12-months)
Atrio-esophageal fistula (within 12-months of ablation procedure)
Death (within 7 days of ablation procedure)
measure: Change in Quality of Life Between Baseline and 12 Months: Atrial Fibrillation Effect on QualiTy-of-life (AFEQT)
time frame: Baseline and 12 months
description: Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) questionnaire completed at baseline and 12 month visits. The AFEQT instrument yields scores from 0 (representing the worst possible debilitation from AF) to 100 (representing no reduction in quality of life from AF).
measure: Change in Quality of Life Between Baseline and 12 Months: Medical Outcome Study Short Form-12 (SF-12) Physical Component
time frame: Baseline and 12 months
description: Medical Outcome Study Short Form-12 (SF-12) questionnaire completed at baseline and 12 month visits. The SF-12 instrument has two composite scores, one for physical health and one for mental health. Each yields scores from 0 (representing the worst possible debilitation) to 100 (representing no reduction in quality of life).
measure: Change in Quality of Life Between Baseline and 12 Months: Medical Outcome Study Short Form-12 (SF-12) Mental Component
time frame: Baseline and 12 months
description: Medical Outcome Study Short Form-12 (SF-12) questionnaire completed at baseline and 12 month visits. The SF-12 instrument has two composite scores, one for physical health and one for mental health. Each yields scores from 0 (representing the worst possible debilitation) to 100 (representing no reduction in quality of life).
arm group label: Treatment Arm
arm group type: Experimental
description: Subjects enrolled and treated with Arctic Front Advance Cardiac CryoAblation Catheter
intervention type: Device
intervention name: Arctic Front Advance Cardiac CryoAblation Catheter
description: Cryoablation
arm group label: Treatment Arm
other name: Freezor MAX Cardiac CryoAblation Catheter
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Hugh Calkins, MD
role: Principal Investigator
affiliation: Johns Hopkins University
last name: Vivek Reddy, MD
role: Principal Investigator
affiliation: Icahn School of Medicine at Mount Sinai
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country: Canada
country: Japan
country: United States
responsible party type: Sponsor
mesh term: Atrial Fibrillation
sharing ipd: No
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