<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/NCT01687036</url>
  </required_header>
  <id_info>
    <org_study_id>CoolLoop First</org_study_id>
    <nct_id>NCT01687036</nct_id>
  </id_info>
  <brief_title>Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System</brief_title>
  <official_title>Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>afreeze GmbH</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>afreeze GmbH</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Primary Endpoint Safety and tolerability of ablation using the AFreeze Cryoablation System&#xD;
      consisting of the ablation CoolLoop® catheter, its steerable sheath and the cryoconsole&#xD;
      Cryo-Caddy will be assessed and expressed in number of participants with Adverse Events&#xD;
      (AEs).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Therefore, the primary endpoint will be a measurement of the following parameters and&#xD;
      expressed in number of participants with AE:&#xD;
&#xD;
        -  deformation of the catheter loop resulting in entrapment of the catheter in the heart&#xD;
           and difficulties removing the catheter during visit 3 (treatment)&#xD;
&#xD;
        -  phrenic nerve palsy during visit 3 (treatment)- onset and time course between visit 3&#xD;
           (treatment) and visit 5 (discharge) of death, pericardial tamponade, valve damage&#xD;
           requiring surgery and hemorrhage requiring transfusion.&#xD;
&#xD;
        -  onset and time course between visit 3 (treatment) and visit 9 (final visit) of&#xD;
           atrioesophageal fistula, sepsis, abscesses, endocarditis, stroke, transient ischemic&#xD;
           attack, and pulmonary vein (PV) stenosis requiring intervention.&#xD;
&#xD;
      Secondary Endpoint&#xD;
&#xD;
      The following parameters will be assessed and expressed in number of participants with&#xD;
      AE/duration time:&#xD;
&#xD;
        -  feasibility, defined by the ability to position the catheter in the proximal part in&#xD;
           each of the PVs using an over-the-wire technique, forming the cryo-applicator of the&#xD;
           catheter to a loop by operating the catheter handle, position-ing the loop at the wall&#xD;
           of the PV antrum and delivering cryothermia.&#xD;
&#xD;
        -  acute efficacy of catheter ablation is defined as the percentage of electrodes within&#xD;
           the PV without measureable signals.&#xD;
&#xD;
        -  clinical efficacy of catheter ablation defined by freedom of Atrial Fibrillation (AF)&#xD;
           four, eight and twelve weeks after ablation.&#xD;
&#xD;
        -  procedure time defined from introduction of the CoolLoop® catheter into the left atrium&#xD;
           until removal of the CoolLoop® catheter from the left atrium after termination of the&#xD;
           last cryoapplication.&#xD;
&#xD;
        -  fluoroscopy time defined from introduction of the CoolLoop® catheter into the left&#xD;
           atrium until removal of the CoolLoop® catheter from the left atrium after termination of&#xD;
           the last cryoapplication.&#xD;
&#xD;
        -  cumulative cryoablation time.&#xD;
&#xD;
        -  onset and time course between visit 3 (treatment) and visit 5 (discharge) of&#xD;
           pneumothorax, hemothorax, femoral pseudoaneurysm, arteriovenous fistulae, hemorrhage not&#xD;
           requiring transfusion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</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>Safety of Ablation Using the AFreeze Cryoablation System Consisting of the CoolLoop® Ablation Catheter, Its Steerable Sheath and the Cryoconsole Cryo-Caddy Assessed by Recording All Serious Adverse Events (SAEs)</measure>
    <time_frame>3 months</time_frame>
    <description>The primary study objective is assessed by recording all Serious Adverse Events (SAEs).&#xD;
Primary endpoint: measurement of the following parameters:&#xD;
deformation of the catheter loop resulting in entrapment of the catheter in the heart and difficulties removing the catheter during visit 3 (treatment).&#xD;
phrenic nerve palsy during visit 3 (treatment).&#xD;
onset and time course between visit 3 (treatment) and visit 5 (discharge) of death, pericardial tamponade, valve damage requiring surgery and hemorrhage requiring transfusion.&#xD;
onset and time course between visit 3 (treatment) and visit 9 (final visit) of atrioesophageal fistula, sepsis, abscesses, endocarditis, stroke, transient ischemic attack, and PV stenosis requiring intervention.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tolerability of Ablation Using the AFreeze Cryoablation System</measure>
    <time_frame>Treatment duration, up to 6 hours</time_frame>
    <description>The primary study objective is assessed by recording all Adverse Events (AEs).&#xD;
Primary endpoint: measurement of the following parameters:&#xD;
- deformation of the catheter loop resulting in entrapment of the catheter in the heart and difficulties removing the catheter during visit 3 (treatment).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Feasibility of Catheter Ablation Measured by Number of Participants Treated With the AFreeze Cryoablation System.</measure>
    <time_frame>Treatment Duration</time_frame>
    <description>Feasibility, defined by the ability to position the catheter in the proximal part in each of the pulmonary veins (PVs) using an over-the-wire technique, forming the cryo-applicator of the catheter to a loop by operating the catheter handle, positioning the loop at the wall of the PV antrum and delivering cryothermia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute Efficacy of Catheter Ablation</measure>
    <time_frame>Treatment Duration</time_frame>
    <description>Absolute percentage of PVs isolated with the CoolLoop® catheter.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Efficacy of Catheter Ablation</measure>
    <time_frame>First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013</time_frame>
    <description>During follow-up recurrence of AF was reported by the patient and documented by ECG in 8 patients (80%). 2 patients remained free of recurrences of AF.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedure Time</measure>
    <time_frame>Average procedure time: 251 min. 06 sec. (range 126 - 320 min.)</time_frame>
    <description>Procedure time was defined from introduction of the CoolLoop® catheter into the left atrium until removal of the CoolLoop® catheter from the left atrium after termination of the last cryo-application.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fluoroscopy Time</measure>
    <time_frame>Treatment Duration</time_frame>
    <description>Fluoroscopy time was defined from introduction of the CoolLoop® catheter into the left atrium until removal of the CoolLoop® catheter from the left atrium after termination of the last cryo - application. Accumulated time using fluoroscopy during procedure time.&#xD;
Average fluoroscopy time was 44 min. 01 sec. (range 17 min. 03 sec. - 59 min.).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative Cryoablation Time</measure>
    <time_frame>First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013</time_frame>
    <description>Cryoablation time was defined as the cumulative duration of all cryoapplications in each single study patient.&#xD;
Average cryoablation time was 114 min. 33 sec. (range 80 - 130 min.).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AE</measure>
    <time_frame>First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013</time_frame>
    <description>18 AEs were recorded in 7 out of 10 patients. 3 AEs were definitely related to treatment and one AE was definitely device related. All patients recovered completely.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Cryoablation</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Cryoablation</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cryoablation</intervention_name>
    <description>Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System</description>
    <arm_group_label>Cryoablation</arm_group_label>
    <other_name>Cool Loop first</other_name>
    <other_name>Cryoablation of Atrial Fibrillation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 18 - 70 years&#xD;
&#xD;
          -  symptomatic paroxysmal AF, according to the actual guidelines of the Eu-ropean Society&#xD;
             of Cardiology, despite treatment with at least one antiarr- hythmic drug&#xD;
&#xD;
          -  at least one episode of AF within the last 3 months documented by ECG&#xD;
&#xD;
          -  signed and dated informed consent documented by the patient, indicating that the&#xD;
             patient has been informed of all the pertinent aspects of the trial prior to study&#xD;
             enrollment&#xD;
&#xD;
          -  female subjects of childbearing potential can be included, if they: agree to use, and&#xD;
             be able to comply with, effective contraception without in-terruption, from study&#xD;
             enrollment, throughout hospitalization and until 12 weeks after catheter ablation (day&#xD;
             0, visit 3). This applies unless the subject commits to absolute and continued&#xD;
             abstinence. The following are effective methods of contraception:&#xD;
&#xD;
          -  Implant,&#xD;
&#xD;
          -  Levonorgestrel-releasing intrauterine system (IUS),&#xD;
&#xD;
          -  Medroxyprogesterone acetate depot,&#xD;
&#xD;
          -  Tubal sterilization,&#xD;
&#xD;
          -  Sexual intercourse with a vasectomized male partner only; vasectomy must be confirmed&#xD;
             by two negative semen ana-lyses,&#xD;
&#xD;
          -  Ovulation inhibitory progesterone-only pills (i.e., desoge-strel). (Combined oral&#xD;
             contraceptive pills are not recommended. If a subject was using combined oral&#xD;
             contraception, she must switch to one of the methods above. The increased risk of&#xD;
             venous thromboembolism (VTE) continues for 4 to 6 weeks after stopping combined oral&#xD;
             contraception.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  left atrial diameter &gt; 50 mm as assessed by transthoracic echocardiogra-phy,&#xD;
&#xD;
          -  electrical cardioversion performed later than seven days after onset of AF,&#xD;
&#xD;
          -  advanced structural heart disease including&#xD;
&#xD;
          -  moderate-to-severe valvular stenosis or regurgitation,&#xD;
&#xD;
          -  previous myocardial infarction with impaired left ventricular systolic function,&#xD;
&#xD;
          -  congenital heart disease,&#xD;
&#xD;
          -  left ventricular ejection fraction &lt; 45% during sinus rhythm,&#xD;
&#xD;
          -  coronary artery bypass graft surgery within the last 3 months.&#xD;
&#xD;
          -  chronic obstructive pulmonary disease treated with beta-sympathomimetic drugs,&#xD;
&#xD;
          -  severe respiratory insufficiency,&#xD;
&#xD;
          -  known bleeding diathesis or intolerance of heparin or oral anticoagulation,&#xD;
&#xD;
          -  previous AF ablation,&#xD;
&#xD;
          -  left atrial thrombus,&#xD;
&#xD;
          -  severe comorbidity,&#xD;
&#xD;
          -  hyperthyreosis,&#xD;
&#xD;
          -  any condition, including the presence of laboratory abnormalities, which would place&#xD;
             the subject at unacceptable risk if he / she were to participate in the study or&#xD;
             confound the ability to interpret data from the study,&#xD;
&#xD;
          -  any serious medical condition, laboratory abnormality, or psychiatric illness, that&#xD;
             would prevent the subject from signing the Informed Consent Form,&#xD;
&#xD;
          -  pregnant or lactating females,&#xD;
&#xD;
          -  other severe conditions, which makes the patient unsuitable to participate in the&#xD;
             study, as judged by the Investigator,&#xD;
&#xD;
          -  the patient is active in another clinical trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Markus Stuehlinger, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University Innsbruck</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical University Innsbruck</name>
      <address>
        <city>Innsbruck</city>
        <zip>6020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AKH Linz</name>
      <address>
        <city>Linz</city>
        <zip>4020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>July 18, 2012</study_first_submitted>
  <study_first_submitted_qc>September 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2012</study_first_posted>
  <results_first_submitted>July 19, 2013</results_first_submitted>
  <results_first_submitted_qc>November 25, 2013</results_first_submitted_qc>
  <results_first_posted type="Estimate">January 13, 2014</results_first_posted>
  <last_update_submitted>November 14, 2018</last_update_submitted>
  <last_update_submitted_qc>November 14, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Atrial fibrillation</keyword>
  <keyword>Cryoablation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment period: September 3,2012 - December 14, 2012 Locations: Medical University Innsbruck, General Hospital Linz</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Cryoablation</title>
          <description>Cryoablation&#xD;
Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System (single treatment during visit 3).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </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>Cryoablation</title>
          <description>Cryoablation&#xD;
Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="10"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="57.6" spread="7.6"/>
                  </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="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </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>Austria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Safety of Ablation Using the AFreeze Cryoablation System Consisting of the CoolLoop® Ablation Catheter, Its Steerable Sheath and the Cryoconsole Cryo-Caddy Assessed by Recording All Serious Adverse Events (SAEs)</title>
        <description>The primary study objective is assessed by recording all Serious Adverse Events (SAEs).&#xD;
Primary endpoint: measurement of the following parameters:&#xD;
deformation of the catheter loop resulting in entrapment of the catheter in the heart and difficulties removing the catheter during visit 3 (treatment).&#xD;
phrenic nerve palsy during visit 3 (treatment).&#xD;
onset and time course between visit 3 (treatment) and visit 5 (discharge) of death, pericardial tamponade, valve damage requiring surgery and hemorrhage requiring transfusion.&#xD;
onset and time course between visit 3 (treatment) and visit 9 (final visit) of atrioesophageal fistula, sepsis, abscesses, endocarditis, stroke, transient ischemic attack, and PV stenosis requiring intervention.</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cryoablation</title>
            <description>Cryoablation&#xD;
Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System</description>
          </group>
        </group_list>
        <measure>
          <title>Safety of Ablation Using the AFreeze Cryoablation System Consisting of the CoolLoop® Ablation Catheter, Its Steerable Sheath and the Cryoconsole Cryo-Caddy Assessed by Recording All Serious Adverse Events (SAEs)</title>
          <description>The primary study objective is assessed by recording all Serious Adverse Events (SAEs).&#xD;
Primary endpoint: measurement of the following parameters:&#xD;
deformation of the catheter loop resulting in entrapment of the catheter in the heart and difficulties removing the catheter during visit 3 (treatment).&#xD;
phrenic nerve palsy during visit 3 (treatment).&#xD;
onset and time course between visit 3 (treatment) and visit 5 (discharge) of death, pericardial tamponade, valve damage requiring surgery and hemorrhage requiring transfusion.&#xD;
onset and time course between visit 3 (treatment) and visit 9 (final visit) of atrioesophageal fistula, sepsis, abscesses, endocarditis, stroke, transient ischemic attack, and PV stenosis requiring intervention.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Tolerability of Ablation Using the AFreeze Cryoablation System</title>
        <description>The primary study objective is assessed by recording all Adverse Events (AEs).&#xD;
Primary endpoint: measurement of the following parameters:&#xD;
- deformation of the catheter loop resulting in entrapment of the catheter in the heart and difficulties removing the catheter during visit 3 (treatment).</description>
        <time_frame>Treatment duration, up to 6 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cryoablation</title>
            <description>Cryoablation&#xD;
Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System</description>
          </group>
        </group_list>
        <measure>
          <title>Tolerability of Ablation Using the AFreeze Cryoablation System</title>
          <description>The primary study objective is assessed by recording all Adverse Events (AEs).&#xD;
Primary endpoint: measurement of the following parameters:&#xD;
- deformation of the catheter loop resulting in entrapment of the catheter in the heart and difficulties removing the catheter during visit 3 (treatment).</description>
          <units>AE (device related)</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Feasibility of Catheter Ablation Measured by Number of Participants Treated With the AFreeze Cryoablation System.</title>
        <description>Feasibility, defined by the ability to position the catheter in the proximal part in each of the pulmonary veins (PVs) using an over-the-wire technique, forming the cryo-applicator of the catheter to a loop by operating the catheter handle, positioning the loop at the wall of the PV antrum and delivering cryothermia.</description>
        <time_frame>Treatment Duration</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cryoablation</title>
            <description>Cryoablation&#xD;
Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System</description>
          </group>
        </group_list>
        <measure>
          <title>Feasibility of Catheter Ablation Measured by Number of Participants Treated With the AFreeze Cryoablation System.</title>
          <description>Feasibility, defined by the ability to position the catheter in the proximal part in each of the pulmonary veins (PVs) using an over-the-wire technique, forming the cryo-applicator of the catheter to a loop by operating the catheter handle, positioning the loop at the wall of the PV antrum and delivering cryothermia.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </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>
        <type>Secondary</type>
        <title>Acute Efficacy of Catheter Ablation</title>
        <description>Absolute percentage of PVs isolated with the CoolLoop® catheter.</description>
        <time_frame>Treatment Duration</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cryoablation</title>
            <description>Cryoablation&#xD;
Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System</description>
          </group>
        </group_list>
        <measure>
          <title>Acute Efficacy of Catheter Ablation</title>
          <description>Absolute percentage of PVs isolated with the CoolLoop® catheter.</description>
          <units>percentage of isolated PVs</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clinical Efficacy of Catheter Ablation</title>
        <description>During follow-up recurrence of AF was reported by the patient and documented by ECG in 8 patients (80%). 2 patients remained free of recurrences of AF.</description>
        <time_frame>First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cryoablation</title>
            <description>Cryoablation&#xD;
Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Efficacy of Catheter Ablation</title>
          <description>During follow-up recurrence of AF was reported by the patient and documented by ECG in 8 patients (80%). 2 patients remained free of recurrences of AF.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Procedure Time</title>
        <description>Procedure time was defined from introduction of the CoolLoop® catheter into the left atrium until removal of the CoolLoop® catheter from the left atrium after termination of the last cryo-application.</description>
        <time_frame>Average procedure time: 251 min. 06 sec. (range 126 - 320 min.)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cryoablation</title>
            <description>Cryoablation&#xD;
Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System</description>
          </group>
        </group_list>
        <measure>
          <title>Procedure Time</title>
          <description>Procedure time was defined from introduction of the CoolLoop® catheter into the left atrium until removal of the CoolLoop® catheter from the left atrium after termination of the last cryo-application.</description>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="251.1" spread="59.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Fluoroscopy Time</title>
        <description>Fluoroscopy time was defined from introduction of the CoolLoop® catheter into the left atrium until removal of the CoolLoop® catheter from the left atrium after termination of the last cryo - application. Accumulated time using fluoroscopy during procedure time.&#xD;
Average fluoroscopy time was 44 min. 01 sec. (range 17 min. 03 sec. - 59 min.).</description>
        <time_frame>Treatment Duration</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cryoablation</title>
            <description>Cryoablation&#xD;
Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System</description>
          </group>
        </group_list>
        <measure>
          <title>Fluoroscopy Time</title>
          <description>Fluoroscopy time was defined from introduction of the CoolLoop® catheter into the left atrium until removal of the CoolLoop® catheter from the left atrium after termination of the last cryo - application. Accumulated time using fluoroscopy during procedure time.&#xD;
Average fluoroscopy time was 44 min. 01 sec. (range 17 min. 03 sec. - 59 min.).</description>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44" spread="13.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cumulative Cryoablation Time</title>
        <description>Cryoablation time was defined as the cumulative duration of all cryoapplications in each single study patient.&#xD;
Average cryoablation time was 114 min. 33 sec. (range 80 - 130 min.).</description>
        <time_frame>First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cryoablation</title>
            <description>Cryoablation&#xD;
Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System</description>
          </group>
        </group_list>
        <measure>
          <title>Cumulative Cryoablation Time</title>
          <description>Cryoablation time was defined as the cumulative duration of all cryoapplications in each single study patient.&#xD;
Average cryoablation time was 114 min. 33 sec. (range 80 - 130 min.).</description>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="113.9" spread="18.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>AE</title>
        <description>18 AEs were recorded in 7 out of 10 patients. 3 AEs were definitely related to treatment and one AE was definitely device related. All patients recovered completely.</description>
        <time_frame>First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cryoablation</title>
            <description>Cryoablation&#xD;
Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System</description>
          </group>
        </group_list>
        <measure>
          <title>AE</title>
          <description>18 AEs were recorded in 7 out of 10 patients. 3 AEs were definitely related to treatment and one AE was definitely device related. All patients recovered completely.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013 (6 months and 15 days)</time_frame>
      <desc>Patients were closely followed for adverse events during treatment and within the defined follow up period according to the study protocol. All Adverse Events including intercurrent disease had to be documented in the patient's medical file and subsequently in the case report form.</desc>
      <group_list>
        <group group_id="E1">
          <title>Cryoablation</title>
          <description>Cryoablation&#xD;
Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>CTCAE V4.03 (NCI)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalization</sub_title>
                <assessment>Systematic Assessment</assessment>
                <description>Hospitalization due to recurrent atrial fibrillation.</description>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>groin hematoma</sub_title>
                <description>Groin hematoma with arterial bleeding from arteria femoralis sin. during puncture of vena femoralis sin. Bleeding stopped by surgical Intervention.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <default_vocab>CTCAE V4.03 (NCI)</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="7" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>anemia</sub_title>
                <description>anemia due to art. bleeding</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>atrial fibrillation</sub_title>
                <assessment>Systematic Assessment</assessment>
                <description>recurrent atrial fibrillation</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hospitalization</sub_title>
                <assessment>Systematic Assessment</assessment>
                <description>Hospitalization due to recurrent atrial fibrillation</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>dyscardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>hyperthyreosis factitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>burning eyes</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>dyspepsia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>dizzyness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>neck pain</sub_title>
                <description>neck pain (Mb. Bechterew)</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>back pain</sub_title>
                <description>back pain</description>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>catheter loop not retractable to straight position</sub_title>
                <description>Catheter loop not retractable to straight position; catheter could be retracted after &quot;rescue maneuver&quot; as defined in the system's user manual.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>air embolism</sub_title>
                <description>air embolism (after introduction of investigational device into left atrium ST-Elevation in ECG observed; transient Hypotension)</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>groin hematoma with art. bleeding</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>intermittent ST elevation</sub_title>
                <description>intermittent ST elevation (susp. air embolism). ST elevation: finding on an electrocardiogram, wherein the trace in the ST segment is abnormally high above the isoelectric line.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </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>Following approval of the Sponsor and before publishing or presenting data related to the Trial or the Device, Research lnstitution, Principal lnvestigator, and Co-lnvestigator agree to submit copies of any and all proposed manuscripts or abstracts to Sponsor at least 30 days in advance of the date that the applicable party proposes to submit such proposed manuscripts or abstracts to a publisher or other third party.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Markus Stühlinger, MD</name_or_title>
      <organization>Medical University Innsbruck, Department of Internal Medicine III, Cardiology</organization>
      <phone>+43 512 504 ext 81 320</phone>
      <email>markus.stuehlinger@uki.at</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/NCT01687036
org study id: CoolLoop First
nct id: NCT01687036
lead sponsor: 
has dmc: Yes
Primary Endpoint Safety and tolerability of ablation using the AFreeze Cryoablation System
      consisting of the ablation CoolLoop® catheter, its steerable sheath and the cryoconsole
      Cryo-Caddy will be assessed and expressed in number of participants with Adverse Events
      (AEs).
Therefore, the primary endpoint will be a measurement of the following parameters and
      expressed in number of participants with AE:

        -  deformation of the catheter loop resulting in entrapment of the catheter in the heart
           and difficulties removing the catheter during visit 3 (treatment)

        -  phrenic nerve palsy during visit 3 (treatment)- onset and time course between visit 3
           (treatment) and visit 5 (discharge) of death, pericardial tamponade, valve damage
           requiring surgery and hemorrhage requiring transfusion.

        -  onset and time course between visit 3 (treatment) and visit 9 (final visit) of
           atrioesophageal fistula, sepsis, abscesses, endocarditis, stroke, transient ischemic
           attack, and pulmonary vein (PV) stenosis requiring intervention.

      Secondary Endpoint

      The following parameters will be assessed and expressed in number of participants with
      AE/duration time:

        -  feasibility, defined by the ability to position the catheter in the proximal part in
           each of the PVs using an over-the-wire technique, forming the cryo-applicator of the
           catheter to a loop by operating the catheter handle, position-ing the loop at the wall
           of the PV antrum and delivering cryothermia.

        -  acute efficacy of catheter ablation is defined as the percentage of electrodes within
           the PV without measureable signals.

        -  clinical efficacy of catheter ablation defined by freedom of Atrial Fibrillation (AF)
           four, eight and twelve weeks after ablation.

        -  procedure time defined from introduction of the CoolLoop® catheter into the left atrium
           until removal of the CoolLoop® catheter from the left atrium after termination of the
           last cryoapplication.

        -  fluoroscopy time defined from introduction of the CoolLoop® catheter into the left
           atrium until removal of the CoolLoop® catheter from the left atrium after termination of
           the last cryoapplication.

        -  cumulative cryoablation time.

        -  onset and time course between visit 3 (treatment) and visit 5 (discharge) of
           pneumothorax, hemothorax, femoral pseudoaneurysm, arteriovenous fistulae, hemorrhage not
           requiring transfusion.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety of Ablation Using the AFreeze Cryoablation System Consisting of the CoolLoop® Ablation Catheter, Its Steerable Sheath and the Cryoconsole Cryo-Caddy Assessed by Recording All Serious Adverse Events (SAEs)
time frame: 3 months
description: The primary study objective is assessed by recording all Serious Adverse Events (SAEs).
Primary endpoint: measurement of the following parameters:
deformation of the catheter loop resulting in entrapment of the catheter in the heart and difficulties removing the catheter during visit 3 (treatment).
phrenic nerve palsy during visit 3 (treatment).
onset and time course between visit 3 (treatment) and visit 5 (discharge) of death, pericardial tamponade, valve damage requiring surgery and hemorrhage requiring transfusion.
onset and time course between visit 3 (treatment) and visit 9 (final visit) of atrioesophageal fistula, sepsis, abscesses, endocarditis, stroke, transient ischemic attack, and PV stenosis requiring intervention.
measure: Tolerability of Ablation Using the AFreeze Cryoablation System
time frame: Treatment duration, up to 6 hours
description: The primary study objective is assessed by recording all Adverse Events (AEs).
Primary endpoint: measurement of the following parameters:
- deformation of the catheter loop resulting in entrapment of the catheter in the heart and difficulties removing the catheter during visit 3 (treatment).
measure: Feasibility of Catheter Ablation Measured by Number of Participants Treated With the AFreeze Cryoablation System.
time frame: Treatment Duration
description: Feasibility, defined by the ability to position the catheter in the proximal part in each of the pulmonary veins (PVs) using an over-the-wire technique, forming the cryo-applicator of the catheter to a loop by operating the catheter handle, positioning the loop at the wall of the PV antrum and delivering cryothermia.
measure: Acute Efficacy of Catheter Ablation
time frame: Treatment Duration
description: Absolute percentage of PVs isolated with the CoolLoop® catheter.
measure: Clinical Efficacy of Catheter Ablation
time frame: First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013
description: During follow-up recurrence of AF was reported by the patient and documented by ECG in 8 patients (80%). 2 patients remained free of recurrences of AF.
measure: Procedure Time
time frame: Average procedure time: 251 min. 06 sec. (range 126 - 320 min.)
description: Procedure time was defined from introduction of the CoolLoop® catheter into the left atrium until removal of the CoolLoop® catheter from the left atrium after termination of the last cryo-application.
measure: Fluoroscopy Time
time frame: Treatment Duration
description: Fluoroscopy time was defined from introduction of the CoolLoop® catheter into the left atrium until removal of the CoolLoop® catheter from the left atrium after termination of the last cryo - application. Accumulated time using fluoroscopy during procedure time.
Average fluoroscopy time was 44 min. 01 sec. (range 17 min. 03 sec. - 59 min.).
measure: Cumulative Cryoablation Time
time frame: First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013
description: Cryoablation time was defined as the cumulative duration of all cryoapplications in each single study patient.
Average cryoablation time was 114 min. 33 sec. (range 80 - 130 min.).
measure: AE
time frame: First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013
description: 18 AEs were recorded in 7 out of 10 patients. 3 AEs were definitely related to treatment and one AE was definitely device related. All patients recovered completely.
arm group label: Cryoablation
arm group type: Other
description: Cryoablation
intervention type: Device
intervention name: Cryoablation
description: Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System
arm group label: Cryoablation
other name: Cool Loop first
other name: Cryoablation of Atrial Fibrillation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Markus Stuehlinger, MD
role: Principal Investigator
affiliation: Medical University Innsbruck
facility: 
facility: 
country: Austria
responsible party type: Sponsor
mesh term: Atrial Fibrillation
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 