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

Atrial Fibrillation Clinical Trial

— METACSA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02389218
• Other study ID #: 2013/1113
• Status: Completed
• Phase: Phase 4
• Start date: March 3, 2015
• Est. completion date: May 14, 2020

Study information

• Verified date: July 2023
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: May 14, 2020
• Est. primary completion date: May 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• single ablation (CryoBalloonAblation (CBA)
Cryoablation at entry, after randomization to this group

Drug:
• sequential drug adjustment (propafenone, sotalol or flecainide)
Correct drug dosage at entry, sequential adjustment / titration, in stage 2 amiodarone

Locations

Country	Name	City	State
Belgium	Brussels Heart Centre	Brussels
Belgium	Saint Luc	Brussels
Belgium	Dept Cardiologie	Gent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sinus rhythm	Sinus rhythm at one year	one year
Secondary	Reduction LA volume	Reduction left atrial volume in successfully treated patients	one year
Secondary	Number of cardioversions	Number of cardioversions	one year
Secondary	Percentage on anti arrhythmic drugs (AAD)	Percentage on AAD in each group	6 months
Secondary	Percentage on AAD	Percentage on AAD in each group	12 months
Secondary	Vascular complications	Vascular complications, including tamponade	one year
Secondary	Stroke, transient ischemic attack (TIA)	Stroke, TIA (symptomatic)	one year
Secondary	Serious adverse events (SAE)	Adverse events leading to admission or death	one year
Secondary	Freedom of AF	Freedom of atrial fibrillation with all means	one year