<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/NCT04474054</url>
  </required_header>
  <id_info>
    <org_study_id>CS0766</org_study_id>
    <nct_id>NCT04474054</nct_id>
  </id_info>
  <brief_title>A Single Arm Pilot Study of Pulsed Field Ablation in the Treatment of Paroxysmal Atrial Fibrillation</brief_title>
  <acronym>FARA-Free</acronym>
  <official_title>FARA-Free: A Single Arm Pilot Study of Pulsed Field Ablation in the Treatment of Paroxysmal Atrial Fibrillation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Farapulse, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Farapulse, 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 objective of this pilot study is to confirm that endocardial ablation using the FARAPULSE&#xD;
      Ablation System Plus with commercial design devices is both safe and effective for treating&#xD;
      drug-resistant paroxysmal atrial fibrillation (PAF).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, multi-center, single arm safety and effectiveness pilot study.&#xD;
      Subjects will undergo percutaneous PFA ablation for pulmonary vein isolation and at the&#xD;
      clinical discretion of the investigator receive PFA ablation of additional arrhythmogenic&#xD;
      locations. Subjects will be followed at 7 days (telephonic), 30 days, 90 days, 6 months and&#xD;
      12 months for adverse events, recurrence of arrhythmia after a 90-day Blanking Period and&#xD;
      other relevant outcome measures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 7, 2020</start_date>
  <completion_date type="Actual">December 21, 2021</completion_date>
  <primary_completion_date type="Actual">December 21, 2021</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>Occurence of Device-or Procedure-related Early and Late-onset of Serious Adverse Events</measure>
    <time_frame>7 days to12 Months</time_frame>
    <description>Includes serious adverse events which are device- or procedure-related, and as define din Composite Safety Endpoint definition table occurring within 7 days of the index procedure or hospital discharge, whichever is later, and diagnosed at any time during the follow-up period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Freedom From Recurrence of Symptomatic Atrial Fibrillation, Atrial Tachycardia or Atrial Flutter</measure>
    <time_frame>12 months</time_frame>
    <description>Includes both acute procedural success (successful electrical isolation of set of lesions around the ostia of all pulmonary veins) and therapeutic success (Re-treatment for AF with ablation using study devices, or if necessary, a commercially approved ablation device after a 3 month blanking period constitute a treatment failure.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Paroxysmal Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>FARAPULSE Ablation System Plus</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ablation using the FARAPULSE Ablation System Plus</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Catheter ablation to treat paroxysmal atrial fibrillation</intervention_name>
    <description>A pulmonary vein isolation will be performed using catheter ablation</description>
    <arm_group_label>FARAPULSE Ablation System Plus</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:Study subjects are required to meet all the following inclusion criteria&#xD;
        to participate in this study:&#xD;
&#xD;
          1. Patients with documented drug resistant symptomatic PAF&#xD;
&#xD;
          2. Patients who are ≥ 18 and ≤ 75 years of age on the day of enrollment.&#xD;
&#xD;
          3. Patient participation requirements:&#xD;
&#xD;
               1. Lives locally.&#xD;
&#xD;
               2. Is willing and capable of providing Informed Consent to undergo study procedures.&#xD;
&#xD;
               3. Is willing to participate in all examinations and follow-up visits and tests&#xD;
                  associated with this clinical study.&#xD;
&#xD;
        Exclusion Criteria: Subjects will be excluded from participating in this study if they meet&#xD;
        any one of the following exclusion criteria:&#xD;
&#xD;
          1. AF that is:&#xD;
&#xD;
               1. Persistent&#xD;
&#xD;
               2. Secondary to electrolyte imbalance, thyroid disease, alcohol abuse or other&#xD;
                  reversible / non-cardiac causes&#xD;
&#xD;
               3. Longstanding&#xD;
&#xD;
          2. Left atrial anteroposterior diameter ≥ 5.0 cm as documented by transthoracic&#xD;
             echocardiography (TTE) or computed tomography (CT)&#xD;
&#xD;
          3. Any of the following cardiac procedures, implants or conditions:&#xD;
&#xD;
               1. Clinically significant arrhythmias other than AF, AFL or AT&#xD;
&#xD;
               2. Previous endocardial or epicardial ablation or surgery for AF&#xD;
&#xD;
               3. Hemodynamically significant valvular disease&#xD;
&#xD;
               4. Prosthetic heart valve&#xD;
&#xD;
               5. Heart Failure for example NYHA Class III or IV CHF, LVEF &lt;40%, Heart failure&#xD;
                  hospitalization&#xD;
&#xD;
               6. Atrial or ventricular septal defect closure&#xD;
&#xD;
               7. Atrial myxoma&#xD;
&#xD;
               8. Left atrial thrombus&#xD;
&#xD;
               9. Left atrial appendage device or occlusion&#xD;
&#xD;
              10. Pacemaker, implantable cardioverter defibrillator or cardiac resynchronization&#xD;
                  therapy devices&#xD;
&#xD;
              11. Significant or symptomatic hypotension&#xD;
&#xD;
              12. Bradycardia or chronotropic incompetence&#xD;
&#xD;
              13. History of pericarditis&#xD;
&#xD;
              14. History of rheumatic fever&#xD;
&#xD;
              15. History of congenital heart disease with any residual anatomic or conduction&#xD;
                  abnormality&#xD;
&#xD;
              16. Any pulmonary vein abnormality, stenosis or stenting&#xD;
&#xD;
          4. Any of the following cardiovascular procedures, implants, or conditions:&#xD;
&#xD;
             a. Within the 3 months preceding enrollment:&#xD;
&#xD;
             i. Myocardial infarction&#xD;
&#xD;
             ii. Unstable angina&#xD;
&#xD;
             iii. Percutaneous coronary intervention&#xD;
&#xD;
             iv. Treatment with amiodarone&#xD;
&#xD;
             b. Within the 6 months preceding enrollment:&#xD;
&#xD;
             i. Heart surgery&#xD;
&#xD;
             ii. Stroke or TIA&#xD;
&#xD;
             iii. Any thromboembolic event&#xD;
&#xD;
             iv. Carotid stenting or endarterectomy&#xD;
&#xD;
             v. Pericarditis or pericardial effusion&#xD;
&#xD;
             c. Within the 12 months following enrollment:&#xD;
&#xD;
             i. Any likelihood of cardiac surgery or transplant&#xD;
&#xD;
          5. History of blood clotting or bleeding abnormalities.&#xD;
&#xD;
          6. Contraindication to, or unwillingness to use, systemic anticoagulation&#xD;
&#xD;
          7. Contraindications to both CT and MRI&#xD;
&#xD;
          8. Sensitivity to contrast media not controlled by premedication&#xD;
&#xD;
          9. Women of childbearing potential who are pregnant, lactating, not using birth control&#xD;
             or planning to become pregnant during the anticipated study period&#xD;
&#xD;
         10. Medical conditions that would prevent participation in the study, interfere with&#xD;
             assessment or therapy, significantly raise the risk of study participation, or&#xD;
             confound data or its interpretation, including but not limited to&#xD;
&#xD;
               1. Body mass index (BMI) &gt; 40&#xD;
&#xD;
               2. Solid organ or hematologic transplant, or currently being evaluated for an organ&#xD;
                  transplant&#xD;
&#xD;
               3. Severe lung disease, pulmonary hypertension, or any lung disease involving&#xD;
                  abnormal blood gases or significant dyspnea&#xD;
&#xD;
               4. Renal insufficiency with an estimated creatinine clearance &lt; 30 mL/min/1.73 m2,&#xD;
                  or any history of renal dialysis or renal transplant&#xD;
&#xD;
               5. Active malignancy or history of treated cancer within 24 months of enrollment&#xD;
&#xD;
               6. Clinically significant gastrointestinal problems involving the esophagus, stomach&#xD;
                  and/or untreated acid reflux&#xD;
&#xD;
               7. Clinically significant infection&#xD;
&#xD;
               8. Predicted life expectancy less than one year&#xD;
&#xD;
         11. Clinically significant psychological condition that in the investigator's opinion&#xD;
             would prohibit the subject's ability to meet the protocol requirements&#xD;
&#xD;
         12. Current or anticipated enrollment in any other clinical study&#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>Ante Anic</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital of Split</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>KBC Split</name>
      <address>
        <city>Split</city>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Croatia</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <results_first_submitted>March 29, 2023</results_first_submitted>
  <results_first_submitted_qc>April 19, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">April 21, 2023</results_first_posted>
  <last_update_submitted>April 19, 2023</last_update_submitted>
  <last_update_submitted_qc>April 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Catheter Ablation</keyword>
  <keyword>Paroxysmal Atrial Fibrillaltion</keyword>
  <keyword>Pulmonary Vein Isolation</keyword>
  <keyword>Atrial Fibrillation</keyword>
  <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>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 13, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/54/NCT04474054/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Intent To Treat (ITT)</title>
          <description>Enrolled subjects who undergo one or more ablation at the index procedure using the study device.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Intent To Treat (ITT)</title>
          <description>Enrolled subjects who undergo one or more ablation at the index procedure using the study device.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="15"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58.3" spread="13.2"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Croatia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index</title>
          <units>kg/m2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27.3" spread="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Time Between First Documented Atrial Fibrillation Diagnosis and Enrollment</title>
          <population>Data unavailable for all 10 subjects</population>
          <units>months</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12.2" spread="11.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Occurence of Device-or Procedure-related Early and Late-onset of Serious Adverse Events</title>
        <description>Includes serious adverse events which are device- or procedure-related, and as define din Composite Safety Endpoint definition table occurring within 7 days of the index procedure or hospital discharge, whichever is later, and diagnosed at any time during the follow-up period.</description>
        <time_frame>7 days to12 Months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>FARAPULSE Endocardial Ablation</title>
            <description>Subjects who are treated with the FARAPULSE Endocardial Ablation System for paroxysmal atrial fibrillation.&#xD;
FARAPULSE Endocardial Ablation System: Endocardial ablation using the FARAPULSE Endocardial Ablation System.</description>
          </group>
        </group_list>
        <measure>
          <title>Occurence of Device-or Procedure-related Early and Late-onset of Serious Adverse Events</title>
          <description>Includes serious adverse events which are device- or procedure-related, and as define din Composite Safety Endpoint definition table occurring within 7 days of the index procedure or hospital discharge, whichever is later, and diagnosed at any time during the follow-up period.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Freedom From Recurrence of Symptomatic Atrial Fibrillation, Atrial Tachycardia or Atrial Flutter</title>
        <description>Includes both acute procedural success (successful electrical isolation of set of lesions around the ostia of all pulmonary veins) and therapeutic success (Re-treatment for AF with ablation using study devices, or if necessary, a commercially approved ablation device after a 3 month blanking period constitute a treatment failure.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>FARAPULSE Endocardial Ablation</title>
            <description>Subjects who are treated with the FARAPULSE Endocardial Ablation System for paroxysmal atrial fibrillation.&#xD;
FARAPULSE Endocardial Ablation System: Endocardial ablation using the FARAPULSE Endocardial Ablation System.</description>
          </group>
        </group_list>
        <measure>
          <title>Freedom From Recurrence of Symptomatic Atrial Fibrillation, Atrial Tachycardia or Atrial Flutter</title>
          <description>Includes both acute procedural success (successful electrical isolation of set of lesions around the ostia of all pulmonary veins) and therapeutic success (Re-treatment for AF with ablation using study devices, or if necessary, a commercially approved ablation device after a 3 month blanking period constitute a treatment failure.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 Months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>FARAPULSE Endocardial Ablation</title>
          <description>Subjects who are treated with the FARAPULSE Endocardial Ablation System for paroxysmal atrial fibrillation.&#xD;
FARAPULSE Endocardial Ablation System: Endocardial ablation using the FARAPULSE Endocardial Ablation System.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>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="15"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial Tachycardia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Supraventricular Tachycardia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Transient Ischemic Attack</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>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="11" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Supraventricular Tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Vascular Access Complication</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Corona Virus Infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Hospitalization</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </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>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Christopher (Kit) Schneider</name_or_title>
      <organization>FARAPULSE</organization>
      <phone>617-686-7661</phone>
      <email>christopher.schneider@bsci.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/NCT04474054
org study id: CS0766
nct id: NCT04474054
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: Yes
The objective of this pilot study is to confirm that endocardial ablation using the FARAPULSE
      Ablation System Plus with commercial design devices is both safe and effective for treating
      drug-resistant paroxysmal atrial fibrillation (PAF).
This is a prospective, multi-center, single arm safety and effectiveness pilot study.
      Subjects will undergo percutaneous PFA ablation for pulmonary vein isolation and at the
      clinical discretion of the investigator receive PFA ablation of additional arrhythmogenic
      locations. Subjects will be followed at 7 days (telephonic), 30 days, 90 days, 6 months and
      12 months for adverse events, recurrence of arrhythmia after a 90-day Blanking Period and
      other relevant outcome measures.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Occurence of Device-or Procedure-related Early and Late-onset of Serious Adverse Events
time frame: 7 days to12 Months
description: Includes serious adverse events which are device- or procedure-related, and as define din Composite Safety Endpoint definition table occurring within 7 days of the index procedure or hospital discharge, whichever is later, and diagnosed at any time during the follow-up period.
measure: Freedom From Recurrence of Symptomatic Atrial Fibrillation, Atrial Tachycardia or Atrial Flutter
time frame: 12 months
description: Includes both acute procedural success (successful electrical isolation of set of lesions around the ostia of all pulmonary veins) and therapeutic success (Re-treatment for AF with ablation using study devices, or if necessary, a commercially approved ablation device after a 3 month blanking period constitute a treatment failure.
arm group label: FARAPULSE Ablation System Plus
arm group type: Experimental
description: Ablation using the FARAPULSE Ablation System Plus
intervention type: Device
intervention name: Catheter ablation to treat paroxysmal atrial fibrillation
description: A pulmonary vein isolation will be performed using catheter ablation
arm group label: FARAPULSE Ablation System Plus
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Ante Anic
role: Principal Investigator
affiliation: University Hospital of Split
facility: 
country: Croatia
responsible party type: Sponsor
mesh term: Atrial Fibrillation
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 