Catheter Ablation Compared With Pharmacological Therapy for Atrial Fibrillation (CAPTAF Trial) (CAPTAF)
Atrial Fibrillation, Quality of Life
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring catheter ablation, atrial fibrillation
Eligibility Criteria
Inclusion Criteria:
- 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.
- The first diagnosis of AF must have been first noted more than 6 months prior to consideration.
- At least one AF episode documented on 12-lead ECG or 2-channel telemetry/ Holter recording during the previous 12 months.
- 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
- 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:
- 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).
- AF secondary to a transient or correctable abnormality including electrolyte imbalance, trauma, recent surgery, infection, toxic ingestion, and uncontrolled thyroid disease.
- Atrial fibrillation episodes triggered by another uniform supraventricular tachycardia.
- Untreated or uncontrolled hypertension
- Valvular disease requiring chronic anticoagulation or planned valve surgery within 2 years.
- Contraindication to treatment with Warfarin or other anticoagulants.
- 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.
- Left atrial diameter > 60 mm.
- Unstable angina or acute myocardial infarction within last 3 months.
- Cardiac revascularization procedure within last 6 months.
- Prior cardiac surgery or planned cardiac corrective surgery within 1 year.
- Prior AF ablation procedure
- 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.
- Patients with intra-atrial thrombus, tumor, or another abnormality in whom transseptal catheterization or appropriate vascular access is precluded.
- Renal failure requiring dialysis or abnormalities of liver function tests
- Participant in investigational clinical or device trial.
- Pregnant women.
- 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.
- Psychological problem that might limit compliance.
- Active abuse of alcohol or other substance which may be causative of AF and/or might affect compliance.
Sites / Locations
- Carina Blomström Lundqvist
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Catheterablation
Antiarrhythmic drug Class IC or III.
Pulmonary vein isolation with Cryo-energy using a Arctic Front™ Cardiac CryoAblation Catheter or an irrigated radiofrequency ablation catheter, with an optional roof line.
Serial testing of oral antiarrhythmic drugs; amiodarone 600 mg once daily 7-10 days, then 100-200 mg once daily; sotalol: 80-160 mg twice daily; flecainide 100 to 150 mg twice daily or entire dose as slow-release formula once daily; propafenone 300 mg twice daily; disopyramide 250-375mg twice daily, or dronedarone 400 mg twice Daily.