<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/NCT04461691</url>
  </required_header>
  <id_info>
    <org_study_id>POLAR-HF</org_study_id>
    <nct_id>NCT04461691</nct_id>
  </id_info>
  <brief_title>Cryoballoon Pulmonary Vein Isolation for Atrial Fibrillation With Heart Failure</brief_title>
  <acronym>POLAR-HF</acronym>
  <official_title>Cryoballoon Pulmonary Vein Isolation for Atrial Fibrillation With Heart Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Josefs-Hospital Wiesbaden GmbH</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St. Josefs-Hospital Wiesbaden GmbH</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The combination of atrial fibrillation (AF) and heart failure (HF) is common and implies a&#xD;
      poor prognosis. Pulmonary vein isolation is an established method for the treatment of&#xD;
      symptomatic AF in patients with normal heart function and has been shown to be more effective&#xD;
      than drug therapy. Recently, radiofrequency ablation has shown a positive effect in patients&#xD;
      with AF and HF. POLAR-HF has been designed to investigate efficacy and safety of cryoballoon&#xD;
      pulmonary vein isolation in patients with paroxysmal or persistent AF and severe HF (LVEF ≤&#xD;
      40%).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">July 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Open label</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Primary Outcome Measures (Number of recurrence)</measure>
    <time_frame>60 months</time_frame>
    <description>Number of subjects with recurrence of atrial fibrillation, atrial flutter, atrial tachycardia or re-ablation after a blanking Period of 90 days after the initial cryoablation procedure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary Outcome Measures (number of safety events)</measure>
    <time_frame>60 months</time_frame>
    <description>2. Number of subjects with a primary safety event including a composite of death from any cause, stroke or transient ischemic attack and serious procedure-related adverse events (Major Bleeding by International Society on Thrombosis and Hemostasis (ISTH) criteria, pericardial effusion, cerebrovascular or systemic embolism, phrenic paresis, major groin site complications requiring treatment)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Secondary Outcome Measures (number of deaths)</measure>
    <time_frame>60 months</time_frame>
    <description>Number of all-cause death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary Outcome Measures (procedural success)</measure>
    <time_frame>60 months</time_frame>
    <description>2. Incidence of acute procedural success assessed by successful isolation of all pulmonary veins</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary Outcome Measures (rehospitalization)</measure>
    <time_frame>60 months</time_frame>
    <description>3. Number of subjects reporting a first unplanned rehospitalization for cardiovasvular causes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary Outcome Measures (procedure duration)</measure>
    <time_frame>60 months</time_frame>
    <description>4. Total procedure duration and left-atrial dwell time (in minutes)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary Outcome Measures (total time)</measure>
    <time_frame>60 months</time_frame>
    <description>5. Total fluoroscopy time (in minutes)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary Outcome Measures (total contrast use)</measure>
    <time_frame>60 months</time_frame>
    <description>6. Total contrast dye use (in milliliters)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1200</enrollment>
  <condition>Atrial Fibrillation</condition>
  <condition>Heart Failure</condition>
  <condition>Cryoballon Ablation</condition>
  <arm_group>
    <arm_group_label>Heart Failure</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Cryoballoon pulmonary vein isolation is a common method for catheter ablation of atrial fibrillation. Cryoenergy is applied through a balloon in a single-step approach resulting in necrosis by tissue freezing.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal cardiac function</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Cryoballoon pulmonary vein isolation is a common method for catheter ablation of atrial fibrillation. Cryoenergy is applied through a balloon in a single-step approach resulting in necrosis by tissue freezing.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cryoballoon Pulmonary Vein Isolation</intervention_name>
    <description>Cryoballoon pulmonary vein isolation is a common method for catheter ablation of atrial fibrillation. Cryoenergy is applied through a balloon in a single-step approach resulting in necrosis by tissue freezing.</description>
    <arm_group_label>Heart Failure</arm_group_label>
    <arm_group_label>Normal cardiac function</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Symptomatic paroxysmal or persistent atrial fibrillation&#xD;
&#xD;
          -  Patients with severe heart failure (LVEF ≤40%, assigned to heart failure group)&#xD;
&#xD;
          -  Patients with normal cardiac function (assigned to control group)&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  Consent capacity&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age under 18 years&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Lack of consent capacity&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joachim Ehrlich, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Josefs-Hospital Wiesbaden GmbH</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Andreas Boehmer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Josefs-Hospital Wiesbaden GmbH</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Joachim Ehrlich, MD</last_name>
    <phone>+496111771201</phone>
    <email>jehrlich@joho.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Andreas Boehmer, MD</last_name>
    <phone>+496111771201</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>St. Josefs-Hospital Wiesbaden GmbH</name>
      <address>
        <city>Wiesbaden</city>
        <zip>65189</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joachim Ehrlich, Prof. Dr.</last_name>
      <phone>+496111771201</phone>
      <email>jehrlich@joho.de</email>
    </contact>
    <contact_backup>
      <last_name>Andreas Boehmer, Dr. med.</last_name>
      <phone>+496111771201</phone>
      <email>aboehmer@joho.de</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>May 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>April 16, 2023</last_update_submitted>
  <last_update_submitted_qc>April 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
    <mesh_term>Atrial Fibrillation</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/NCT04461691
org study id: POLAR-HF
nct id: NCT04461691
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The combination of atrial fibrillation (AF) and heart failure (HF) is common and implies a
      poor prognosis. Pulmonary vein isolation is an established method for the treatment of
      symptomatic AF in patients with normal heart function and has been shown to be more effective
      than drug therapy. Recently, radiofrequency ablation has shown a positive effect in patients
      with AF and HF. POLAR-HF has been designed to investigate efficacy and safety of cryoballoon
      pulmonary vein isolation in patients with paroxysmal or persistent AF and severe HF (LVEF ≤
      40%).
allocation: Non-Randomized
intervention model: Single Group Assignment
intervention model description: Open label
primary purpose: Treatment
masking: None (Open Label)
measure: Primary Outcome Measures (Number of recurrence)
time frame: 60 months
description: Number of subjects with recurrence of atrial fibrillation, atrial flutter, atrial tachycardia or re-ablation after a blanking Period of 90 days after the initial cryoablation procedure
measure: Primary Outcome Measures (number of safety events)
time frame: 60 months
description: 2. Number of subjects with a primary safety event including a composite of death from any cause, stroke or transient ischemic attack and serious procedure-related adverse events (Major Bleeding by International Society on Thrombosis and Hemostasis (ISTH) criteria, pericardial effusion, cerebrovascular or systemic embolism, phrenic paresis, major groin site complications requiring treatment)
measure: Secondary Outcome Measures (number of deaths)
time frame: 60 months
description: Number of all-cause death
measure: Secondary Outcome Measures (procedural success)
time frame: 60 months
description: 2. Incidence of acute procedural success assessed by successful isolation of all pulmonary veins
measure: Secondary Outcome Measures (rehospitalization)
time frame: 60 months
description: 3. Number of subjects reporting a first unplanned rehospitalization for cardiovasvular causes
measure: Secondary Outcome Measures (procedure duration)
time frame: 60 months
description: 4. Total procedure duration and left-atrial dwell time (in minutes)
measure: Secondary Outcome Measures (total time)
time frame: 60 months
description: 5. Total fluoroscopy time (in minutes)
measure: Secondary Outcome Measures (total contrast use)
time frame: 60 months
description: 6. Total contrast dye use (in milliliters)
arm group label: Heart Failure
arm group type: Other
description: Cryoballoon pulmonary vein isolation is a common method for catheter ablation of atrial fibrillation. Cryoenergy is applied through a balloon in a single-step approach resulting in necrosis by tissue freezing.
arm group label: Normal cardiac function
arm group type: Other
description: Cryoballoon pulmonary vein isolation is a common method for catheter ablation of atrial fibrillation. Cryoenergy is applied through a balloon in a single-step approach resulting in necrosis by tissue freezing.
intervention type: Procedure
intervention name: Cryoballoon Pulmonary Vein Isolation
description: Cryoballoon pulmonary vein isolation is a common method for catheter ablation of atrial fibrillation. Cryoenergy is applied through a balloon in a single-step approach resulting in necrosis by tissue freezing.
arm group label: Heart Failure
arm group label: Normal cardiac function
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Joachim Ehrlich, MD
role: Principal Investigator
affiliation: St. Josefs-Hospital Wiesbaden GmbH
last name: Andreas Boehmer, MD
role: Principal Investigator
affiliation: St. Josefs-Hospital Wiesbaden GmbH
last name: Joachim Ehrlich, MD
phone: +496111771201
email: jehrlich@joho.de
last name: Andreas Boehmer, MD
phone: +496111771201
facility: 
status: Recruiting
contact: 
contact backup: 
country: Germany
responsible party type: Sponsor
mesh term: Heart Failure
mesh term: Atrial Fibrillation