Neurosciences

Title
CABANA Trial
Trial Number
202146091609
Number of Participants
3,000
Principal Investigator

David J. Wilber

M.D., FAHA, FACC
Cardiology
George M. Eisenberg Professor of Cardiovascular Sciences
Eligibility

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 140/90 mmHg [93], diabetes defined as a fasting glucose >126 mg/dl [94], 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

Purpose

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.

Enrollment

(708) 216-2644

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