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.
- 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.
- 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: 03/05/2013