Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial
The (Catheter Ablation Versus Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial) 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 decreasing the incidence of the composite endpoint of total mortality, disabling stroke, serious bleeding, or cardiac arrest in patients with untreated or incompletely treated AF.
- device : Left atrial ablation
- drug : Rate or Rhythm Control Therapy
Ages Eligible For Study:
- Over the preceding 6 months have: 1. ?2 paroxysmal (electrocardiographic documentation of at least 1) AF episodes lasting ?1 hour in duration: (that terminate spontaneously within 7 days or cardioversion is performed within 48h of AF onset): or 2. electrocardiographic documentation of 1 persistent AF episode: (sustained for ?7 days or cardioversion is performed more than 48h after AF onset): or 3. electrocardiographic documentation of 1 longstanding persistent AF episode: (continuous AF of duration >1 year). - Warrant active therapy (within the past 3 months) beyond simple ongoing observation - Be eligible for catheter ablation and ?2 sequential rhythm control and/or ?2 rate control drugs. - Be ?65 yrs of age, or <65 yrs with one or more of the following risk factors for stroke: Hypertension (treated and/or defined as a BP >140/90 mmHg) , Diabetes (treated and/or defined as a fasting glucose ?126 mg/dl) , Congestive heart failure (including systolic or diastolic heart failure), Prior stroke, TIA or systemic emboli, Atherosclerotic vascular disease (previous MI, peripheral arterial disease or aortic plaque), LA size >5.0 cm (or volume index ?40 cc/m2), or EF ?35. - Have the capacity to understand and sign an informed consent form. - Be ?18 years of age. - NOTE- Subjects <65 yrs of age whose only risk factor is hypertension must have a second risk factor or LV hypertrophy to qualify.Patients receiving new drug therapy initiated within the previous 3 months may continue that therapy if randomized to the drug therapy arm. Patients may have documented atrial flutter in addition to atrial fibrillation and remain eligible for enrollment.