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Catheter Ablation Versus Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial (Cabana)
- The CABANA Trial has the overall goal of establishing the appropriate roles for medical and ablative intervention for atrial fibrillation (AF). The CABANA Trial is designed to test the hypothesis that the treatment strategy of left atrial catheter ablation for the purpose of eliminating atrial fibrillation (AF) will be superior to current state-of-the-art therapy with either rate control or rhythm control drugs for reducing total mortality in patients with untreated or incompletely treated AF.
- Cindy Machado at 303-724-6472
- Eligibility and Other Participant Information
- 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