Catheter Ablation compared with Pharmacological Therapy for Atrial Fibrillation – the CAPTAF trial - captaf

• Conditions: To study the effect of catheter ablation (using CE marked products) on the quality of life an in patients with atrial fibrillation depsite treatment with conevntional antiarrhythmic medical therapy.atrial fibrillation is thus the disease to be investigated; MedDRA version: 9.1Level: LLTClassification code 10066664Term: Recurrent symptomatic atrial fibrillation

• Registration Number: EUCTR2008-001384-11-SE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-04
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

1.Age: 30-70 years.
2.Patients with symptoms related to 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 Ca channel inhibitors.
3.The first diagnosis of AF must have been first noted more than 6 months prior to consideration.
4.At least one AF episode documented on 12-lead ECG or 2-channel telemetry/Holter recording during the previous 12 months.
5.Paroxysmal AF with occurrence of at least one symptomatic episodes (patient history) in the previous 2 months that merits non-pharmacological intervention (see classification), or
6.Persistent AF 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.
2.AF secondary to a transient or correctable abnormality .
3.Atrial fibrillation episodes triggered by another uniform SVT.
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 NYHA class III or IV or left ventricular ejection fraction ( < 35 %.
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.ICD, CRT device, Dual chamber- and VVI-pacemaker if needed for VVI pacing, as well as AV block II-III and sustained ventricular tachyarrhythmias.
14.Patients 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.
19.Psychological problem that might limit compliance.
20.Active abuse of alcohol or other substance.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified