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

• Status: Unknown status
• Trial end date: 2020-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Ghent
• Treatments: Flecainide; Propafenone; Sotalol

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