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

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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

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).

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Other: Holter monitoring Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cryoballoon Ablation for Early Persistent Atrial Fibrillation
Actual Study Start Date : December 8, 2014
Actual Primary Completion Date : June 22, 2017
Actual Study Completion Date : September 12, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Cryoballoon ablation
Subjects will wear holter monitors at baseline, 6 months and 12 months
Other: Holter monitoring
Subjects will wear holter monitors at baseline, 6 months and 12 months.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)

  2. 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.

  3. Sinus rhythm restoration being followed by chronic prevention of AF recurrence [ Time Frame: 12 months ]
  4. Use of class I and class III antiarrhythmic drugs [ Time Frame: 12 months ]
  5. Changes in quality of life measurements between baseline, 6 months and 12 months after procedure [ Time Frame: Baseline, 6 months, 12 months ]
  6. Adverse events required to be collected during the study [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02213731


Locations
France
Hôpital Henri Mondor
Créteil, France
CHU de Grenoble
Grenoble, France
CHU de la Timone
Marseille Cedex, France
CHU - Hôpitaux de Rouen
Rouen Cedex, France
Clinique Pasteur
Toulouse, France
Germany
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, Germany
Charite - Universitaetsmedizin
Berlin, Germany, 10117
Cardioangiologisches Centrum Bethanien
Frankfurt, Germany
Asklepios Klinik St. Georg
Hamburg, Germany
Krankenhaus Porz am Rhein
Köln, Germany
St. Vinzenz-Hospital
Köln, Germany
Klinikum Nürnberg Süd
Nürnberg, Germany
Uniklinik Ulm
Ulm, Germany
Greece
Henry Dunant Hospital Center
Athens, Greece, 11526
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Investigators
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

Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT02213731     History of Changes
Other Study ID Numbers: Cryo4 Persistent AF
First Posted: August 11, 2014    Key Record Dates
Last Update Posted: September 19, 2018
Last Verified: September 2018

Keywords provided by Medtronic Cardiac Rhythm and Heart Failure:
Atrial Fibrillation
Persistent Atrial Fibrillation
Cryoablation
Cryoballoon
Pulmonary Vein Isolation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes