Number of Participants
The intent of the CABANA trial is to enroll patients who have new onset or under-treated paroxysmal, persistent or longstanding persistent atrial fibrillation and who warrant therapy for their arrhythmia. Patients must: 1. Have the capacity to understand and sign an informed consent form. 2. Be >18 years of age. 3. Have documented atrial fibrillation episodes >one hour in duration with >two episodes over four months with electrocardiographic documentation of one episode or at least one episode of atrial fibrillation lasting more than one week. 4. Warrant active therapy beyond simple ongoing observation. 5. Be eligible for catheter ablation and >two sequential rhythm control and/or >three rate control drugs. 6. Be >65 years of age or <65 years with one or more of the following risk factors for stroke: Hypertension defined as a BP >140/90 mmHg , diabetes defined as a fasting glucose >126 mg/dl , congestive heart failure (including systolic or diastolic heart failure), prior stroke or TIA, LA size >5.0 cm (or volume index > 40 cc/m2) or EF <35. Subjects <65 years of age whose only risk factor is hypertension must have a second risk factor or LV hypertrophy to qualify.
Atrial fibrillation is an abnormal, rapid heart rhythm coming from the upper chambers of the heart (atria). Atrial fibrillation is the most common type of heart rhythm disorder. Instead of the heart beating in a steady pattern, in atrial fibrillation the upper chambers of the heart quiver rapidly in an unsteady manner. Atrial fibrillation may be treated with drug therapy designed to either prevent the heart rate from going too fast, or with drug therapy designed to maintain normal heart beating. In some institutions, atrial fibrillation also is treated with catheters inserted into blood vessels that can be placed inside the heart to eliminate the hot spots or triggers that start atrial fibrillation (catheter ablation). It is not known whether drug therapy or catheter ablation is better. The Catheter Ablation Versus Anti-arrhythmic Drug Therapy for Atrial Fibrillation (CABANA) study is being done to compare drug therapy and catheter ablation in patients with atrial fibrillation. This study will help decide which treatment approach is best or when one or the other therapy is preferred. The CABANA study also will compare the cost of care for the two treatment approaches and determine the effect these therapies have on quality of life.
You will be assigned to one of two treatment groups by chance. 1,500 participants will be assigned catheter ablation, and the remaining 1,500 participants will be assigned drug therapy. Neither you nor your physician will be able to decide to which group you are assigned.
David J. Wilber
M.D., FAHA, FACC
George M. Eisenberg Professor of Cardiovascular Sciences