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Cryoballoon Ablation for Early Persistent Atrial Fibrillation (Cryo4 Persistent AF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02213731
Recruitment Status : Completed
First Posted : August 11, 2014
Last Update Posted : September 19, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Tracking Information
First Submitted Date  ICMJE July 31, 2014
First Posted Date  ICMJE August 11, 2014
Last Update Posted Date September 19, 2018
Actual Study Start Date  ICMJE December 8, 2014
Actual Primary Completion Date June 22, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 29, 2014)
Single procedure success of cryoballoon ablation on patients with early persistent AF [ Time Frame: 12 months ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 7, 2014)
Single procedure efficacy of cryoballoon ablation on patients with early persistent AF [ Time Frame: 12 months ]
12 month efficacy 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2014)
  • Acute procedural success of cryoballoon ablation on patients with early persistent AF [ Time Frame: Post-procedure ]
    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)
  • Success of cryoballoon ablation on patients with early persistent AF (allowing for multiple procedures) [ Time Frame: 12 months ]
    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.
  • Sinus rhythm restoration being followed by chronic prevention of AF recurrence [ Time Frame: 12 months ]
  • Use of class I and class III antiarrhythmic drugs [ Time Frame: 12 months ]
  • Changes in quality of life measurements between baseline, 6 months and 12 months after procedure [ Time Frame: Baseline, 6 months, 12 months ]
  • Adverse events required to be collected during the study [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2014)
  • Acute procedural success of cryoballoon ablation on patients with early persistent AF [ Time Frame: Post-procedure ]
    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)
  • Efficacy of cryoballoon ablation on patients with early persistent AF (allowing for multiple procedures) [ Time Frame: 12 months ]
    12 month efficacy 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.
  • Sinus rhythm restoration being followed by chronic prevention of AF recurrence [ Time Frame: 12 months ]
  • Use of class I and class III antiarrhythmic drugs [ Time Frame: 12 months ]
  • Changes in quality of life measurements between baseline, 6 months and 12 months after procedure [ Time Frame: Baseline, 6 months, 12 months ]
  • Adverse events required to be collected during the study [ Time Frame: 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cryoballoon Ablation for Early Persistent Atrial Fibrillation (Cryo4 Persistent AF)
Official Title  ICMJE Cryoballoon Ablation for Early Persistent Atrial Fibrillation
Brief Summary 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Atrial Fibrillation
Intervention  ICMJE Other: Holter monitoring
Subjects will wear holter monitors at baseline, 6 months and 12 months.
Study Arms  ICMJE Cryoballoon ablation
Subjects will wear holter monitors at baseline, 6 months and 12 months
Intervention: Other: Holter monitoring
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 29, 2014)
130
Original Estimated Enrollment  ICMJE
 (submitted: August 7, 2014)
120
Actual Study Completion Date  ICMJE September 12, 2017
Actual Primary Completion Date June 22, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with documented symptomatic persistent AF refractory or intolerant to at least 1 class I or III antiarrhythmic medication. Persistent AF defined as:

    • Episode lasting longer than 7 days, but less than 1 year documented by consecutive ECG recordings of 100% AF greater than 7 days apart OR
    • Episode requiring electrical or pharmacological cardioversion after 48 hours of AF documented by continuous recording
  • Date of first diagnosis of persistent AF within the last 12 months preceding the consent date
  • Age between 18 and 75 years
  • Willing to comply with study requirements and give informed consent (defined as legally effective, documented confirmation of a subject's (or their legally authorized representative or guardian) voluntary agreement to participate in a particular clinical study) to participate in this clinical study

Exclusion Criteria:

  • Long-standing persistent AF (has lasted for ≥1 year)
  • Current diagnosis of paroxysmal AF
  • Anteroposterior LA diameter > 5.0 cm by TTE
  • Current intracardiac thrombus
  • Presence of one or more pulmonary vein stents
  • Presence of any pre-existing pulmonary vein stenosis
  • Primary pulmonary hypertension
  • NYHA class IV congestive heart failure and/or documented left ventricular ejection fraction (LVEF) < 40% measure by acceptable cardiac testing (e.g. TTE)
  • Hypertrophic cardiomyopathy
  • Previous LA ablation or surgery
  • Unstable angina
  • Presence of any cardiac valve prosthesis
  • Thrombocytosis, thrombocytopenia
  • Any condition contraindicating chronic anticoagulation
  • Any cardiac surgery, myocardial infarction, PCI / PTCA or coronary artery stenting which occurred during the 3 month interval preceding the consent date
  • Any cerebral ischemic event (strokes or TIAs) which occurred during the 6 month interval preceding the consent date
  • Cryoglobulinemia
  • Presence or likely implant of a permanent pacemaker, biventricular pacemaker, loop recorder, or any type of implantable cardiac defibrillator (with or without biventricular pacing function) within 12 months
  • Uncontrolled hyperthyroidism
  • Any woman known to be pregnant or breastfeeding
  • Active systemic infection
  • Subject is employed by Medtronic or by the department of any of the investigators or is a close relative of any of the investigators
  • Life expectancy ≤ 1 year
  • Currently enrolled or plans to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in concurrent studies is allowed when documented pre-approval is obtained from the Medtronic study manager
  • Exclusion criteria as per local laws (for France, this includes, but is not limited to: incompetent adults or patients that are not affiliated to the French social security system)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Germany,   Greece
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02213731
Other Study ID Numbers  ICMJE Cryo4 Persistent AF
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medtronic Cardiac Rhythm and Heart Failure
Study Sponsor  ICMJE Medtronic Cardiac Rhythm and Heart Failure
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Serge Boveda, M.D. Clinique Pasteur
Principal Investigator: Pascal Defaye, M.D. CHU Michallo, Unité de Rythmologie, Clinique de cardiologie, CHU de Grenoble site Nord - Hôpital Albert Michallon
PRS Account Medtronic Cardiac Rhythm and Heart Failure
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP