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

• Status: Unknown status
• Trial end date: 2018-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Uppsala University Hospital
• Collaborator: Swedish Heart Lung Foundation
• Treatments: Amiodarone; Anti-Arrhythmia Agents; Disopyramide; Dronedarone; Flecainide; Propafenone; Sotalol

Criteria

Inclusion Criteria:

1. Patients with symptoms related to atrial fibrillation (AF), who have failed or been intolerant to at least one drug used for either rate or rhythm control (Vaughan Williams class I, II, or III anti-arrhythmic drug) thus excluding digitalis and Calcium channel inhibitors.

2. The first diagnosis of AF must have been first noted more than 6 months prior to consideration.

3. At least one AF episode documented on 12-lead ECG or 2-channel telemetry/ Holter recording during the previous 12 months.

4. Paroxysmal AF (AF is self-terminating within 7 days of recognized onset) with occurrence of at least one symptomatic episodes (patient history) in the previous 2 months that merits non-pharmacological intervention (see classification), or

5. Persistent AF (AF is not self-terminating within 7 days or is terminated electrically or pharmacologically) with occurrence of at least 2 symptomatic episodes of AF in the previous 12 months, necessitating pharmacological or electrical cardioversions (CV), on or off antiarrhythmic drugs that merits non-pharmacological intervention. Upon cardioversion, it must be documented that sinus rhythm can be maintained for at least 1 hour, to distinguish from permanent AF.

Exclusion Criteria:

1. Patients who have tested 2 or more anti-arrhythmic drugs for rhythm control at highest tolerable dosages (Vaughan Williams class I or III anti-arrhythmic drug; flecainide, propafenone, disopyramide, sotalol or amiodarone).

2. AF secondary to a transient or correctable abnormality including electrolyte imbalance, trauma, recent surgery, infection, toxic ingestion, and uncontrolled thyroid disease.

3. Atrial fibrillation episodes triggered by another uniform supraventricular tachycardia.

4. Untreated or uncontrolled hypertension

5. Valvular disease requiring chronic anticoagulation or planned valve surgery within 2 years.

6. Contraindication to treatment with Warfarin or other anticoagulants.

7. Heart failure with New York Heart Association (NYHA ) class III or IV or left ventricular ejection fraction (LVEF) < 35 %, which is not secondary to AF with inadequate rate control, according to the judgement of the investigator.

8. Left atrial diameter > 60 mm.

9. Unstable angina or acute myocardial infarction within last 3 months.

10. Cardiac revascularization procedure within last 6 months.

11. Prior cardiac surgery or planned cardiac corrective surgery within 1 year.

12. Prior AF ablation procedure

13. Implantable cardioverter-defibrillator, biventricular pacing device, Dual chamber- and single chamber -pacemaker if needed for ventricular pacing, as well as Atrioventricular (AV) block II-III and sustained ventricular tachyarrhythmias.

14. Patients with intra-atrial thrombus, tumor, or another abnormality in whom transseptal catheterization or appropriate vascular access is precluded.

15. Renal failure requiring dialysis or abnormalities of liver function tests

16. Participant in investigational clinical or device trial.

17. Pregnant women.

18. Unwilling or unable to give informed consent or inaccessible for follow-up. Specify if implantable cardiac monitor (ICM) was not accepted by the patient to be implanted.

19. Psychological problem that might limit compliance.

20. Active abuse of alcohol or other substance which may be causative of AF and/or might affect compliance.