<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/NCT03818724</url>
  </required_header>
  <id_info>
    <org_study_id>CooL-TreatS</org_study_id>
    <nct_id>NCT03818724</nct_id>
  </id_info>
  <brief_title>Treatment Success With the CoolLoop Cryoablation System</brief_title>
  <official_title>Treatment Success With the CoolLoop Cryoablation System - Post-Market Surveillance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>afreeze GmbH</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Raffeiner GmbH</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>afreeze GmbH</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This clinical study evaluates the safety and efficacy of the treatment with the CoolLoop®&#xD;
      cryoablation System (sclerotherapy of muscle tissue of the heart by freezing) in patients&#xD;
      with atrial fibrillation (permanent atrial fibrillation excepted) over a follow-up period of&#xD;
      36 months.&#xD;
&#xD;
      A further aim of this study is to evaluate the average duration of procedure and fluoroscopy&#xD;
      times.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 17, 2019</start_date>
  <completion_date type="Anticipated">January 2025</completion_date>
  <primary_completion_date type="Anticipated">January 2025</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>36 Months</target_duration>
  <primary_outcome>
    <measure>Incidence of serious adverse events</measure>
    <time_frame>36 months follow-up period</time_frame>
    <description>Safety is measured by the percentage of participants with serious adverse events (SAEs) up to 36 months post-ablation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Freedom from atrial fibrillation (efficacy) at 36 months post-ablation</measure>
    <time_frame>36 months follow-up period</time_frame>
    <description>Efficacy is measured by the percentage of AF (atrial fibrillation) free patients at 36 months post-ablation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Freedom from atrial fibrillation (efficacy) at 12 and 24 months post-ablation</measure>
    <time_frame>12 and 24 months post-ablation</time_frame>
    <description>Efficacy is measured by the percentage of AF (atrial fibrillation) free patients at 12 and 24 months post-ablation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute procedure success</measure>
    <time_frame>36 months follow-up period</time_frame>
    <description>Acute efficacy of isolation of each of the pulmonary veins defined as the percentage of diagnostic mapping catheter electrode pairs within the pulmonary vein without any detectable pulmonary vein signal in case of redo procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total procedure time</measure>
    <time_frame>Estimated timeframe up to 4 hours</time_frame>
    <description>Total procedure time defined from introduction of the sheath until removal of the sheath</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CoolLoop procedure time</measure>
    <time_frame>Estimated timeframe up to 2 hours</time_frame>
    <description>CoolLoop procedure time defined from introduction of the CoolLoop cryoablation catheter into the left atrium until removal from the left atrium after Termination of the last cryo-application with the CoolLoop cryoablation catheter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total fluoroscopy time</measure>
    <time_frame>Estimated time frame up to 1 hour</time_frame>
    <description>Total fluoroscopy time defined from introduction of the sheath until removal of the sheath</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CoolLoop fluoroscopy time</measure>
    <time_frame>Estimated timeframe up to 30 minutes</time_frame>
    <description>CoolLoop fluoroscopy time defined from introduction of the CoolLoop cryoablation catheter into the left atrium until removal from the left atrium after termination of the last cryo-application with the CoolLoop cryoablation catheter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative cryoablation time</measure>
    <time_frame>Estimated timeframe up to 1 hour</time_frame>
    <description>Cumulative cryoablation time is displayed as &quot;total freeze time&quot; by the cryoconsole at the end of the procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events (AEs) of special interest</measure>
    <time_frame>36 months follow-up period</time_frame>
    <description>Recording of AEs of Special interest and patient reported cardiac arrhythmias</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">540</enrollment>
  <condition>Atrial Fibrillation</condition>
  <condition>Paroxysmal Atrial Fibrillation</condition>
  <condition>Persistent Atrial Fibrillation</condition>
  <condition>Arrhythmias, Cardiac</condition>
  <condition>Cardiovascular Diseases</condition>
  <condition>Heart Diseases</condition>
  <arm_group>
    <arm_group_label>CoolLoop® cryoablation system</arm_group_label>
    <description>Cryoablation for treatment of atrial fibrillation using the CoolLoop® cryoablation system</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CoolLoop® cryoablation system</intervention_name>
    <description>Cryoablation of Atrial Fibrillation using the CoolLoop® Cryoablation System</description>
    <arm_group_label>CoolLoop® cryoablation system</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients have to be planned and be suitable for an ablation procedure. The decision to&#xD;
        treat the patients with the CoolLoop® cryoablation System has already been made in advance&#xD;
        by the Investigator. Informed consent has to be obtained before the ablation procedure.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  atrial fibrillation: permanent AF excepted&#xD;
&#xD;
          -  ECG documented AF within the last 6 months&#xD;
&#xD;
          -  patients planned for an ablation procedure and suitable and planned for treatment with&#xD;
             the CoolLoop® cryoablation system&#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 (patient has received a copy of the ICF)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  indication that the vascular system is not accessible through the left or right groin.&#xD;
&#xD;
          -  indication that a transseptal puncture cannot be performed.&#xD;
&#xD;
          -  any previous ablation or surgery due to AF.&#xD;
&#xD;
          -  important comorbidities such as cardiovascular events within six months of enrollment&#xD;
             or high-risk surgical patients.&#xD;
&#xD;
          -  pregnant women at the time of the cryoablation procedure.&#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;
          -  participation in interventional trials for cardiovascular devices or drugs.&#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>Andreas Kaiser, PhD</last_name>
    <role>Study Director</role>
    <affiliation>afreeze GmbH</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Florian Hintringer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University Innsbruck</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Andreas Kaiser, PhD</last_name>
    <phone>+43 (0) 69911073109</phone>
    <email>andreas.kaiser@afreeze.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>afreeze GmbH</last_name>
    <phone>+43 (0) 512 209012</phone>
    <phone_ext>0</phone_ext>
    <email>clinical.research@afreeze.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Medical University Innsbruck</name>
      <address>
        <city>Innsbruck</city>
        <state>Tirol/Austria</state>
        <zip>6020</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Florian Hintringer, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Marienhaus Klinikum St. Elisabeth Neuwied</name>
      <address>
        <city>Neuwied</city>
        <state>Germany/Rheinland-Pfalz</state>
        <zip>56564</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Burkhard Hügl, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Germany</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>January 21, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>July 20, 2022</last_update_submitted>
  <last_update_submitted_qc>July 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Atrial Fibrillation</keyword>
  <keyword>Paroxysmal Atrial Fibrillation</keyword>
  <keyword>Persistent Atrial Fibrillation</keyword>
  <keyword>Cryoablation</keyword>
  <keyword>Cryosurgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Arrhythmias, Cardiac</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03818724
org study id: CooL-TreatS
nct id: NCT03818724
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This clinical study evaluates the safety and efficacy of the treatment with the CoolLoop®
      cryoablation System (sclerotherapy of muscle tissue of the heart by freezing) in patients
      with atrial fibrillation (permanent atrial fibrillation excepted) over a follow-up period of
      36 months.

      A further aim of this study is to evaluate the average duration of procedure and fluoroscopy
      times.
observational model: Case-Only
time perspective: Prospective
measure: Incidence of serious adverse events
time frame: 36 months follow-up period
description: Safety is measured by the percentage of participants with serious adverse events (SAEs) up to 36 months post-ablation
measure: Freedom from atrial fibrillation (efficacy) at 36 months post-ablation
time frame: 36 months follow-up period
description: Efficacy is measured by the percentage of AF (atrial fibrillation) free patients at 36 months post-ablation
measure: Freedom from atrial fibrillation (efficacy) at 12 and 24 months post-ablation
time frame: 12 and 24 months post-ablation
description: Efficacy is measured by the percentage of AF (atrial fibrillation) free patients at 12 and 24 months post-ablation
measure: Acute procedure success
time frame: 36 months follow-up period
description: Acute efficacy of isolation of each of the pulmonary veins defined as the percentage of diagnostic mapping catheter electrode pairs within the pulmonary vein without any detectable pulmonary vein signal in case of redo procedure
measure: Total procedure time
time frame: Estimated timeframe up to 4 hours
description: Total procedure time defined from introduction of the sheath until removal of the sheath
measure: CoolLoop procedure time
time frame: Estimated timeframe up to 2 hours
description: CoolLoop procedure time defined from introduction of the CoolLoop cryoablation catheter into the left atrium until removal from the left atrium after Termination of the last cryo-application with the CoolLoop cryoablation catheter
measure: Total fluoroscopy time
time frame: Estimated time frame up to 1 hour
description: Total fluoroscopy time defined from introduction of the sheath until removal of the sheath
measure: CoolLoop fluoroscopy time
time frame: Estimated timeframe up to 30 minutes
description: CoolLoop fluoroscopy time defined from introduction of the CoolLoop cryoablation catheter into the left atrium until removal from the left atrium after termination of the last cryo-application with the CoolLoop cryoablation catheter
measure: Cumulative cryoablation time
time frame: Estimated timeframe up to 1 hour
description: Cumulative cryoablation time is displayed as "total freeze time" by the cryoconsole at the end of the procedure
measure: Adverse Events (AEs) of special interest
time frame: 36 months follow-up period
description: Recording of AEs of Special interest and patient reported cardiac arrhythmias
arm group label: CoolLoop® cryoablation system
description: Cryoablation for treatment of atrial fibrillation using the CoolLoop® cryoablation system
intervention type: Device
intervention name: CoolLoop® cryoablation system
description: Cryoablation of Atrial Fibrillation using the CoolLoop® Cryoablation System
arm group label: CoolLoop® cryoablation system
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andreas Kaiser, PhD
role: Study Director
affiliation: afreeze GmbH
last name: Florian Hintringer, MD
role: Principal Investigator
affiliation: Medical University Innsbruck
last name: Andreas Kaiser, PhD
phone: +43 (0) 69911073109
email: andreas.kaiser@afreeze.com
last name: afreeze GmbH
phone: +43 (0) 512 209012
phone ext: 0
email: clinical.research@afreeze.com
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
country: Austria
country: Germany
responsible party type: Sponsor
mesh term: Atrial Fibrillation
mesh term: Cardiovascular Diseases
mesh term: Heart Diseases
mesh term: Arrhythmias, Cardiac