Mayo Clinic Pits Catheter Ablation Against Drugs to Treat AF
June 15, 2009 - Mayo Clinic received $48 million in grants from the National Heart, Lung and Blood Institute (NHLBI), a component of the National Institute of Health, and from industry partners for the Catheter Ablation Versus Anti-Arrhythmic Drug Therapy for Atrial Fibrillation (CABANA) Trial, designed to determine whether catheter ablation is more effective than drug therapy for the treatment of atrial fibrillation.
“Atrial fibrillation affects more than 2 million people in the U.S. and while there are currently a number of effective treatments to control AF and/or reduce the risk, this trial is very important to demonstrate the relative benefit of atrial fibrillation therapies,” said Richard L. Page, M.D., president of the Heart Rhythm Society. “Studies like the CABANA Trial produce valuable research that will help electrophysiologists make more effective treatment decisions and ultimately improve patient care.”
St. Jude Medical Inc. is the leading sponsor of the CABANA Trial. Biosense Webster Inc. will also be a part of a public/private collaboration to fund the clinical trial.
The pivotal trial is intended to determine the effectiveness of catheter ablation in eliminating atrial fibrillation (AF), a condition in which the upper chambers of the heart beat quickly and erratically. The CABANA pivotal trial will last up to six years and will study the treatment of AF in 3,000 patients and 140 centers from around the world. It will randomize patients over three years, with half undergoing catheter ablation and half receiving rate control or rhythm control drug therapy. Douglas Packer, M.D., a cardiologist at Mayo Clinic, will be the principal investigator of the clinical trial. Prior to the launch of this trial, Dr. Packer and Mayo Clinic led a 10-center, 60-patient pilot study. The results of this pilot study will be released later this summer.
The CABANA Trial will be conducted in collaboration with the Heart Rhythm Service and Biomedical Imaging Resources at Mayo Clinic, Rochester, Minn., Duke Clinical Research Institute, Durham, N.C., and CABANA Investigators.
The results from the CABANA trial will add to the growing body of clinical evidence comparing catheter ablation to drug therapy for AF and is designed to go beyond preceding trials, which did not have the ability to examine long term risks of mortality and stroke.
For more information: www.sjm.com, www.biosensewebster.com