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

NCT ID: NCT02389218

Last Updated: 2023-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-03
• Study Completion Date: 2020-05-14

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.

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cryoablation

Cryoballoon single ablation (as described in the reference) at entry after randomization to this group. Single procedure,not to be repeated.

Group Type: EXPERIMENTAL

single ablation (CryoBalloonAblation (CBA)

Intervention Type: DEVICE

Cryoablation at entry, after randomization to this group

Drug

Conventional, available anti arrhythmic drugs (propafenone, sotalol or flecainide), in a first stage, sequential, with amiodarone in second stage

Group Type: ACTIVE_COMPARATOR

sequential drug adjustment (propafenone, sotalol or flecainide)

Intervention Type: DRUG

Correct drug dosage at entry, sequential adjustment / titration, in stage 2 amiodarone

Interventions

single ablation (CryoBalloonAblation (CBA)

Cryoablation at entry, after randomization to this group

Intervention Type: DEVICE

sequential drug adjustment (propafenone, sotalol or flecainide)

Correct drug dosage at entry, sequential adjustment / titration, in stage 2 amiodarone

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luc Jordaens, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Professor of Cardiology

Locations

Brussels Heart Centre

Brussels, , Belgium

Saint Luc

Brussels, , Belgium

Dept Cardiologie

Ghent, , Belgium

Countries

Belgium

References

Van Belle Y, Janse P, Theuns D, Szili-Torok T, Jordaens L. One year follow-up after cryoballoon isolation of the pulmonary veins in patients with paroxysmal atrial fibrillation. Europace. 2008 Nov;10(11):1271-6. doi: 10.1093/europace/eun218.

Reference Type: BACKGROUND

PMID: 18955409 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2013/1113

Identifier Type: -

Identifier Source: org_study_id