Catheter Ablation Compared With Pharmacological Therapy for Atrial Fibrillation (CAPTAF Trial)

Summary

The objective is to compare the efficacy of 2 treatment strategies, catheter ablation of atrial fibrillation versus optimized pharmacological therapy, in patients with symptomatic atrial fibrillation.

It is a randomized, prospective, controlled, open-label multicentre, parallel-group study including 116 patients. Inclusion criteria are patients aged 30-70 years with symptoms related to atrial fibrillation and who have failed or been intolerant to at least one anti-arrhythmic drug, with at least one atrial fibrillation episode documented on ECG during the previous 12 months and at least one symptomatic episode during the previous 2 months or at least 2 symptomatic episodes of persistent AF in the previous 12 months.

Main exclusion criteria are patients who have tested 2 or more anti-arrhythmic drugs for rhythm control, uncontrolled hypertension, valvular disease requiring anticoagulation, planned valve surgery within 2 years, contraindication to treatment with anticoagulants, heart failure, left atrial diameter \> 60 mm, unstable angina or acute myocardial infarction within the last 3 months, cardiac revascularization procedure within the last 6 months, prior cardiac surgery or planned cardiac corrective surgery within 1 year, prior AF ablation procedure.

The primary endpoint is general health-related quality of life at 12 months follow-up. The main secondary endpoints are morbidity and mortality as composite outcome, cardiovascular hospitalization, symptoms, heart failure, left atrial and ventricular function and diameters, exercise capacity, health care economics, rhythm, atrial fibrillation burden, successful versus failed treatment, safety and "cross-overs" over time.

Patients will receive a cardiac monitor, implanted subcutaneously, which will monitor the heart rhythm during a two month "Run-in" period, for the definition of the basic atrial fibrillation burden. Patients will be randomly assigned to an antiarrhythmic drug (for rhythm or rate control) or to left atrial catheter ablation. Evaluation of outcome is at 12, 24, 36 and 48 months of follow-up, while health economy will be evaluated at 24 and 48 months of follow-up.. In case of documented disease progression or unacceptable toxicity, subjects will be switched to the alternative regimen. The main statistical analysis of the primary endpoint will be based on the intention-to-treat population. The trial duration is 48 months.

Conditions

• Atrial Fibrillation
• Quality of Life

Interventions

DEVICE

Catheterablation

Pulmonary vein isolation using either Arctic Front™ Cardiac CryoAblation or irrigated radiofrequency catheter ablation. A linear lesion, a left atrial roof line, is optional for patients with AF recurrence after a first procedure or primarily for patients with persistent AF.

DRUG

Amiodarone

Dosage orally 600 mg once daily for 7-10 days, and 100-200 mg once daily thereafter.

DRUG

Sotalol

Dosage orally 80-160 mg twice daily

DRUG

Flecainide

Dosage orally 100 to 150 mg twice daily or the entire dose as slow-release formula once daily

DRUG

Propafenone

Dosage orally 300 mg twice daily

DRUG

Disopyramide

Dosage orally 250-375 mg twice Daily

DRUG

Dronedarone

Dosage orally 400 mg twice daily

Sponsors & Collaborators

• Swedish Heart Lung Foundation

  collaborator OTHER

• Uppsala University Hospital

  lead OTHER

Principal Investigators

• Carina M Blomström Lundqvist, Professor · Department of Cardiology, University Hospital in Uppsala

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-05-31

Primary Completion

2018-09-30

Completion

2018-09-30

Countries

• Sweden

Study Locations