Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial

Location:

Rochester, MN.

Trial status:

Open for Enrollment

Why is this study being done?

The need for this trial arises out of 1) the rapidly increasing number of pts > 60 years of age with AF accompanied by symptoms and morbidity, 2) the failure of anti-arrhythmic drug therapy to maintain sinus rhythm and reduce mortality, 3) the rapidly increasing application of radio-frequency catheter ablation without appropriate evidence-based validation, and 4) the expanding impact of AF on health care costs. This study will randomize 3000 patients to a strategy of catheter ablation versus pharmacologic therapy with rate or rhythm control drugs. Each pt will have 1) characteristics similar to AFFIRM pts (≥65 yo or <65 with >1 risk factor for stroke, 2) Documented AF warranting treatment, and 3) Eligibility for both catheter ablation and ≥2 anti-arrhythmic or ≥3 rate control drugs. Pts will be followed every 6 months for >2 yrs and will undergo repeat trans-telephonic monitor, Holter monitor, and CT/MR studies to assess the impact of treatment. The CABANA trial will disclose the role of medical and non-pharmacologic therapies for AF, establish the cost and impact of therapy on quality of life and will help determine if AF is a modifiable risk factor for increased mortality.

Who is eligible to participate?

Inclusion Criteria: - Have the capacity to understand and sign an informed consent form - Be ≥18 years of age. - Have documented AF episodes ≥1 hour in duration; with ≥2 episodes over 4 months with electrocardiographic documentation of 1 episode or at least 1 episode of AF lasting more than 1 week - Warrant active therapy beyond simple ongoing observation - Be eligible for both catheter ablation and ≥2 sequential rhythm control and/or ≥3 rate control drugs. - Be ≥65 yrs of age, or <65 yrs with one or more of the following risk factors for stroke: Hypertension, Diabetes, Congestive heart failure, Prior stroke or TIA, LA size ≥5.0 cm (or volume index ≥40 cc/m2), or EF ≥35. Subjects <65 yrs of age whose only risk factor is hypertension must have a second risk factor or LV hypertrophy to qualify. Exclusion Criteria: - Lone AF in the absence of risk factors for stroke in patients <65 years of age - Patients who in the opinion of the managing clinician should not yet receive any therapy for AF - Patients who have failed ≥2 membrane active anti-arrhythmic drugs at a therapeutic dose due to inefficacy - More than one week of amiodarone treatment in the past 3 months - An efficacy failure of full dose amiodarone treatment ≥12 weeks duration at any time - Reversible causes of AF including thyroid disorders, acute alcohol intoxication, recent major surgical procedures, or trauma - Recent cardiac events including MI, PCI, or valve or bypass surgery in the preceding 3 months - Hypertrophic obstructive cardiomyopathy - Class IV angina or Class IV CHF (including past or planned heart transplantation) - Other mandated anti-arrhythmic drug therapy - Heritable arrhythmias or increased risk for torsade de pointes with class I or III drugs - Prior LA catheter ablation with the intention of treating AF - Prior surgical interventions for AF such as the MAZE procedure - Prior AV nodal ablation - Patients with other arrhythmias requiring ablative therapy - Contraindication to warfarin anti-coagulation - Renal failure requiring dialysis - Medical conditions limiting expected survival to <1 year - Women of childbearing potential (unless post-menopausal or surgically sterile) - Participation in any other clinical mortality trial - Unable to give informed consent

Last updated:

3/5/2013

NCT ID:

NCT00911508