<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/NCT02213731</url>
  </required_header>
  <id_info>
    <org_study_id>Cryo4 Persistent AF</org_study_id>
    <nct_id>NCT02213731</nct_id>
  </id_info>
  <brief_title>Cryoballoon Ablation for Early Persistent Atrial Fibrillation (Cryo4 Persistent AF)</brief_title>
  <official_title>Cryoballoon Ablation for Early Persistent Atrial Fibrillation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medtronic Cardiac Rhythm and Heart Failure</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medtronic Cardiac Rhythm and Heart Failure</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this clinical study is to assess the single procedure outcomes of using&#xD;
      cryoballoon ablation without additional empirical lesions and/or complex fractionated&#xD;
      electrogram (CFE) ablations for patients with early persistent atrial fibrillation (&lt;1 year&#xD;
      from first diagnosis of persistent AF).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 8, 2014</start_date>
  <completion_date type="Actual">September 12, 2017</completion_date>
  <primary_completion_date type="Actual">June 22, 2017</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>Single procedure success of cryoballoon ablation on patients with early persistent AF</measure>
    <time_frame>12 months</time_frame>
    <description>12 month success will be defined as absence of adjudicated AF/atrial flutter/atrial tachyarrhythmias &gt;/= 30 seconds in duration from the end of the 90 day blanking period of the cryoballoon ablation procedure to at least 12 months after the cryoballoon ablation procedure. Only Arctic Front Advance catheters may be used to achieve the single procedure success and no additional empirical lesions and/or complex fractionated electrogram (CFE) ablations may be made. Additionally, subjects must not require any other intervention for AF following the index procedure. Right atrial flutter ablations and pharmacological and/or electrical cardioversion can be performed within the 90 day blanking period.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acute procedural success of cryoballoon ablation on patients with early persistent AF</measure>
    <time_frame>Post-procedure</time_frame>
    <description>Acute procedural success is defined as:&#xD;
Only Arctic Front Advance catheters used to achieve procedure success AND&#xD;
All targeted pulmonary veins were isolated (minimally assessed for entrance block and, where assessable, exit block) AND&#xD;
Sinus rhythm is restored at the end of the ablation procedure (with or without cardioversion)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Success of cryoballoon ablation on patients with early persistent AF (allowing for multiple procedures)</measure>
    <time_frame>12 months</time_frame>
    <description>12 month success will be defined as absence of adjudicated AF/atrial flutter/atrial tachyarrhythmias &gt;/= 30 seconds in duration from the end of the 90 day blanking period of the cryoballoon ablation procedure to at least 12 months after the cryoballoon ablation procedure. Only Arctic Front Advance catheters may be used to achieve multiple procedure success and no additional empirical lesions and/or complex fractionated electrogram (CFE) ablations may be made. Additionally, subjects must not require any other intervention for AF. Right atrial flutter ablations and pharmacological and/or electrical cardioversion can be performed within the 90 day blanking period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sinus rhythm restoration being followed by chronic prevention of AF recurrence</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of class I and class III antiarrhythmic drugs</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in quality of life measurements between baseline, 6 months and 12 months after procedure</measure>
    <time_frame>Baseline, 6 months, 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events required to be collected during the study</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">130</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Cryoballoon ablation</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects will wear holter monitors at baseline, 6 months and 12 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Holter monitoring</intervention_name>
    <description>Subjects will wear holter monitors at baseline, 6 months and 12 months.</description>
    <arm_group_label>Cryoballoon ablation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with documented symptomatic persistent AF refractory or intolerant to at&#xD;
             least 1 class I or III antiarrhythmic medication. Persistent AF defined as:&#xD;
&#xD;
               -  Episode lasting longer than 7 days, but less than 1 year documented by&#xD;
                  consecutive ECG recordings of 100% AF greater than 7 days apart OR&#xD;
&#xD;
               -  Episode requiring electrical or pharmacological cardioversion after 48 hours of&#xD;
                  AF documented by continuous recording&#xD;
&#xD;
          -  Date of first diagnosis of persistent AF within the last 12 months preceding the&#xD;
             consent date&#xD;
&#xD;
          -  Age between 18 and 75 years&#xD;
&#xD;
          -  Willing to comply with study requirements and give informed consent (defined as&#xD;
             legally effective, documented confirmation of a subject's (or their legally authorized&#xD;
             representative or guardian) voluntary agreement to participate in a particular&#xD;
             clinical study) to participate in this clinical study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Long-standing persistent AF (has lasted for ≥1 year)&#xD;
&#xD;
          -  Current diagnosis of paroxysmal AF&#xD;
&#xD;
          -  Anteroposterior LA diameter &gt; 5.0 cm by TTE&#xD;
&#xD;
          -  Current intracardiac thrombus&#xD;
&#xD;
          -  Presence of one or more pulmonary vein stents&#xD;
&#xD;
          -  Presence of any pre-existing pulmonary vein stenosis&#xD;
&#xD;
          -  Primary pulmonary hypertension&#xD;
&#xD;
          -  NYHA class IV congestive heart failure and/or documented left ventricular ejection&#xD;
             fraction (LVEF) &lt; 40% measure by acceptable cardiac testing (e.g. TTE)&#xD;
&#xD;
          -  Hypertrophic cardiomyopathy&#xD;
&#xD;
          -  Previous LA ablation or surgery&#xD;
&#xD;
          -  Unstable angina&#xD;
&#xD;
          -  Presence of any cardiac valve prosthesis&#xD;
&#xD;
          -  Thrombocytosis, thrombocytopenia&#xD;
&#xD;
          -  Any condition contraindicating chronic anticoagulation&#xD;
&#xD;
          -  Any cardiac surgery, myocardial infarction, PCI / PTCA or coronary artery stenting&#xD;
             which occurred during the 3 month interval preceding the consent date&#xD;
&#xD;
          -  Any cerebral ischemic event (strokes or TIAs) which occurred during the 6 month&#xD;
             interval preceding the consent date&#xD;
&#xD;
          -  Cryoglobulinemia&#xD;
&#xD;
          -  Presence or likely implant of a permanent pacemaker, biventricular pacemaker, loop&#xD;
             recorder, or any type of implantable cardiac defibrillator (with or without&#xD;
             biventricular pacing function) within 12 months&#xD;
&#xD;
          -  Uncontrolled hyperthyroidism&#xD;
&#xD;
          -  Any woman known to be pregnant or breastfeeding&#xD;
&#xD;
          -  Active systemic infection&#xD;
&#xD;
          -  Subject is employed by Medtronic or by the department of any of the investigators or&#xD;
             is a close relative of any of the investigators&#xD;
&#xD;
          -  Life expectancy ≤ 1 year&#xD;
&#xD;
          -  Currently enrolled or plans to participate in a potentially confounding drug or device&#xD;
             trial during the course of this study. Co-enrollment in concurrent studies is allowed&#xD;
             when documented pre-approval is obtained from the Medtronic study manager&#xD;
&#xD;
          -  Exclusion criteria as per local laws (for France, this includes, but is not limited&#xD;
             to: incompetent adults or patients that are not affiliated to the French social&#xD;
             security system)&#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>Serge Boveda, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinique Pasteur</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Pascal Defaye, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Michallo, Unité de Rythmologie, Clinique de cardiologie, CHU de Grenoble site Nord - Hôpital Albert Michallon</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital Henri Mondor</name>
      <address>
        <city>Créteil</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Grenoble</name>
      <address>
        <city>Grenoble</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de la Timone</name>
      <address>
        <city>Marseille Cedex</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU - Hôpitaux de Rouen</name>
      <address>
        <city>Rouen Cedex</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Pasteur</name>
      <address>
        <city>Toulouse</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herz- und Diabeteszentrum NRW</name>
      <address>
        <city>Bad Oeynhausen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charite - Universitaetsmedizin</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardioangiologisches Centrum Bethanien</name>
      <address>
        <city>Frankfurt</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asklepios Klinik St. Georg</name>
      <address>
        <city>Hamburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Krankenhaus Porz am Rhein</name>
      <address>
        <city>Köln</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Vinzenz-Hospital</name>
      <address>
        <city>Köln</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Nürnberg Süd</name>
      <address>
        <city>Nürnberg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uniklinik Ulm</name>
      <address>
        <city>Ulm</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Dunant Hospital Center</name>
      <address>
        <city>Athens</city>
        <zip>11526</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>Germany</country>
    <country>Greece</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>July 31, 2014</study_first_submitted>
  <study_first_submitted_qc>August 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 11, 2014</study_first_posted>
  <last_update_submitted>September 17, 2018</last_update_submitted>
  <last_update_submitted_qc>September 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Atrial Fibrillation</keyword>
  <keyword>Persistent Atrial Fibrillation</keyword>
  <keyword>Cryoablation</keyword>
  <keyword>Cryoballoon</keyword>
  <keyword>Pulmonary Vein Isolation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT02213731
org study id: Cryo4 Persistent AF
nct id: NCT02213731
lead sponsor: 
has dmc: No
The purpose of this clinical study is to assess the single procedure outcomes of using
      cryoballoon ablation without additional empirical lesions and/or complex fractionated
      electrogram (CFE) ablations for patients with early persistent atrial fibrillation (<1 year
      from first diagnosis of persistent AF).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Single procedure success of cryoballoon ablation on patients with early persistent AF
time frame: 12 months
description: 12 month success will be defined as absence of adjudicated AF/atrial flutter/atrial tachyarrhythmias >/= 30 seconds in duration from the end of the 90 day blanking period of the cryoballoon ablation procedure to at least 12 months after the cryoballoon ablation procedure. Only Arctic Front Advance catheters may be used to achieve the single procedure success and no additional empirical lesions and/or complex fractionated electrogram (CFE) ablations may be made. Additionally, subjects must not require any other intervention for AF following the index procedure. Right atrial flutter ablations and pharmacological and/or electrical cardioversion can be performed within the 90 day blanking period.
measure: Acute procedural success of cryoballoon ablation on patients with early persistent AF
time frame: Post-procedure
description: Acute procedural success is defined as:
Only Arctic Front Advance catheters used to achieve procedure success AND
All targeted pulmonary veins were isolated (minimally assessed for entrance block and, where assessable, exit block) AND
Sinus rhythm is restored at the end of the ablation procedure (with or without cardioversion)
measure: Success of cryoballoon ablation on patients with early persistent AF (allowing for multiple procedures)
time frame: 12 months
description: 12 month success will be defined as absence of adjudicated AF/atrial flutter/atrial tachyarrhythmias >/= 30 seconds in duration from the end of the 90 day blanking period of the cryoballoon ablation procedure to at least 12 months after the cryoballoon ablation procedure. Only Arctic Front Advance catheters may be used to achieve multiple procedure success and no additional empirical lesions and/or complex fractionated electrogram (CFE) ablations may be made. Additionally, subjects must not require any other intervention for AF. Right atrial flutter ablations and pharmacological and/or electrical cardioversion can be performed within the 90 day blanking period.
measure: Sinus rhythm restoration being followed by chronic prevention of AF recurrence
time frame: 12 months
measure: Use of class I and class III antiarrhythmic drugs
time frame: 12 months
measure: Changes in quality of life measurements between baseline, 6 months and 12 months after procedure
time frame: Baseline, 6 months, 12 months
measure: Adverse events required to be collected during the study
time frame: 12 months
arm group label: Cryoballoon ablation
arm group type: Other
description: Subjects will wear holter monitors at baseline, 6 months and 12 months
intervention type: Other
intervention name: Holter monitoring
description: Subjects will wear holter monitors at baseline, 6 months and 12 months.
arm group label: Cryoballoon ablation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Serge Boveda, M.D.
role: Principal Investigator
affiliation: Clinique Pasteur
last name: Pascal Defaye, M.D.
role: Principal Investigator
affiliation: CHU Michallo, Unité de Rythmologie, Clinique de cardiologie, CHU de Grenoble site Nord - Hôpital Albert Michallon
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
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facility: 
facility: 
facility: 
country: France
country: Germany
country: Greece
responsible party type: Sponsor
mesh term: Atrial Fibrillation