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

Sponsor

University Hospital, Ghent (Other)

Overall Status

Unknown status

CT.gov ID

NCT02389218

Collaborator

(none)

167

Enrollment

Locations

Arms

Anticipated Duration (Months)

55.7

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Mar 3, 2015

Anticipated Primary Completion Date :

Mar 1, 2020

Anticipated Study Completion Date :

Mar 1, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Sinus rhythm [one year]
Sinus rhythm at one year

Secondary Outcome Measures

Reduction LA volume [one year]
Reduction left atrial volume in successfully treated patients
Number of cardioversions [one year]
Number of cardioversions
Percentage on anti arrhythmic drugs (AAD) [6 months]
Percentage on AAD in each group
Percentage on AAD [12 months]
Percentage on AAD in each group
Vascular complications [one year]
Vascular complications, including tamponade
Stroke, transient ischemic attack (TIA) [one year]
Stroke, TIA (symptomatic)
Serious adverse events (SAE) [one year]
Adverse events leading to admission or death
Freedom of AF [one year]
Freedom of atrial fibrillation with all means

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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