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A Prospective Study of Medical Therapy Against Cryoballoon Ablation in Symptomatic Recent Onset Persistent AF (METACSA)

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. Identifier: NCT02389218
Recruitment Status : Unknown
Verified May 2017 by University Hospital, Ghent.
Recruitment status was:  Recruiting
First Posted : March 17, 2015
Last Update Posted : May 18, 2017
Information provided by (Responsible Party):
University Hospital, Ghent

Brief Summary:
Prospective trial comparing the efficacy and safety of CryoBalloonAblation (CBA) to standardized medication for treatment of early onset persistent atrial fibrillation (AF) without structural heart disease. The value of CBA in these patients has never been studied; the endpoints for persistent patients are much easier than for paroxysmal patients. Reduction in left atrial (LA) size will be compared versus patients on drug therapy and versus failing patients.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: single ablation (CryoBalloonAblation (CBA) Drug: sequential drug adjustment (propafenone, sotalol or flecainide) Phase 4

Detailed Description:

The total AF history should be shorter than 24 months. Symptomatic patients can be included if they have had within the last year at least 2 episodes of documented AF, lasting minimal 30 sec. One episode in the entire history should have lasted more than 48 h, requiring electrical or pharmacological cardioversion or stopped spontaneously after more than 7 days.

All patients eligible for the study will sign informed consent, have an echocardiogram prior to inclusion to exclude severe left ventricular dysfunction, to rule out significant valve abnormalities, left ventricular hypertrophy and to assess the LA volume and diameter.

Prior to randomization, and after inclusion it is suggested to the local investigators to perform an MRI-scan or CT scan of the LA and pulmonary veins (in both branches of the study ) in eligible patients to assess the anatomy and the left atrial volume. The results should not influence the strategy of treatment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 167 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Study of Medical Therapy Against Cryoballoon Ablation in Symptomatic Recent Onset Persistent Atrial Fibrilation
Actual Study Start Date : March 3, 2015
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Cryoablation
Cryoballoon single ablation (as described in the reference) at entry after randomization to this group. Single procedure,not to be repeated.
Device: single ablation (CryoBalloonAblation (CBA)
Cryoablation at entry, after randomization to this group

Active Comparator: Drug
Conventional, available anti arrhythmic drugs (propafenone, sotalol or flecainide), in a first stage, sequential, with amiodarone in second stage
Drug: sequential drug adjustment (propafenone, sotalol or flecainide)
Correct drug dosage at entry, sequential adjustment / titration, in stage 2 amiodarone

Primary Outcome Measures :
  1. Sinus rhythm [ Time Frame: one year ]
    Sinus rhythm at one year

Secondary Outcome Measures :
  1. Reduction LA volume [ Time Frame: one year ]
    Reduction left atrial volume in successfully treated patients

  2. Number of cardioversions [ Time Frame: one year ]
    Number of cardioversions

  3. Percentage on anti arrhythmic drugs (AAD) [ Time Frame: 6 months ]
    Percentage on AAD in each group

  4. Percentage on AAD [ Time Frame: 12 months ]
    Percentage on AAD in each group

  5. Vascular complications [ Time Frame: one year ]
    Vascular complications, including tamponade

  6. Stroke, transient ischemic attack (TIA) [ Time Frame: one year ]
    Stroke, TIA (symptomatic)

  7. Serious adverse events (SAE) [ Time Frame: one year ]
    Adverse events leading to admission or death

  8. Freedom of AF [ Time Frame: one year ]
    Freedom of atrial fibrillation with all means

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • > 21 years and legally capable
  • First documentation or history of symptomatic AF more than 30 sec within the last 2 years
  • Twice AF within the last year
  • One episode cardioverted after more than 48 hours or spontaneously terminated after more than 7 days
  • Eligible for at least one first step drug therapy (sotalol, propafenone, or flecainide) and for amiodarone
  • Left ventricular ejection fraction estimated > 45%
  • LA diameter < 50 mm (parasternal short axis) and LA volume less than 100 ml (apical view, Area Length method;)
  • CHADS2 ≤ 2
  • Failed AAD strategy, or untreated with AAD
  • No use of Amiodarone in the previous 3 months (except IV or oral for 7 days)
  • Informed consent

Exclusion Criteria:

  • Age > 75 yrs
  • CHF
  • Ischemic heart disease as known in the history
  • (Severe) Left ventricular hypertrophy as shown on echo (IVSd or PWd > 14 mm)
  • Hyperthyroidism
  • Congenital heart disease
  • Hypertrophic Cardiomyopathy, Arrhythmogenic Right ventricular Cardiomyopathy, channelopathies
  • Contra-indications to AAD
  • Long QT syndrome
  • Received already adequately dosed all level 1 drugs (sotalol, propafenone, and flecainide)
  • Pure (typical) atrial flutter as documented on one occasion

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 identifier (NCT number): NCT02389218

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Contact: Pieter Vervaet +3293324349
Contact: Michel De Pauw, MD +3293323460

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Brussels Heart Centre Recruiting
Brussels, Belgium, 1000
Contact: Luc Jordaens, MD    +3228910961   
Contact: Peter Goethals, MD    +3228910961   
Saint Luc Recruiting
Brussels, Belgium
Contact: Jean-Benoit Le Polain De Waroux, MD, PhD    +3227642888   
Dept Cardiologie Recruiting
Gent, Belgium, 9000
Contact: Frederic Van Heuverswyn, MD    +3293323459   
Contact: Luc Jordaens, MD, Phd    +3293323459   
Sponsors and Collaborators
University Hospital, Ghent
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Principal Investigator: Luc Jordaens, MD, PhD Professor of Cardiology
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Responsible Party: University Hospital, Ghent Identifier: NCT02389218    
Other Study ID Numbers: 2013/1113
First Posted: March 17, 2015    Key Record Dates
Last Update Posted: May 18, 2017
Last Verified: May 2017
Keywords provided by University Hospital, Ghent:
atrial fibrillation
catheter ablation
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Autonomic Agents
Peripheral Nervous System Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators