St. Jude Medical Announces Leading Sponsorship Of Landmark Clinical Trial To Study Atrial Fibrillation

Main Category: Heart Disease
Also Included In: Cardiovascular / Cardiology;  Clinical Trials / Drug Trials
Article Date: 15 Jun 2009 - 2:00 PDT

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St. Jude Medical, Inc. (NYSE:STJ) today announced that it is the leading sponsor of the Catheter Ablation Versus Anti-arrhythmic Drug Therapy for Atrial Fibrillation (CABANA) Trial. The pivotal trial, announced by Mayo Clinic, is intended to determine the effectiveness of catheter ablation (using long, narrow tubes to non-invasively reach and destroy abnormal heart tissue) in eliminating atrial fibrillation (AF), a condition in which the upper chambers of the heart beat quickly and erratically.

"The results of the CABANA trial will be significant in shaping the future of cardiac ablation as a treatment and possible cure for AF," said Daniel J. Starks, Chairman, President and Chief Executive Officer of St. Jude Medical. "Supporting clinical trials like CABANA is an important part of our mission of advancing the practice of medicine through medical technology to help improve patient outcomes."

The CABANA pivotal trial will last up to six years and will study the treatment of atrial fibrillation in a total of 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. Mayo Clinic and Drs. Packer and Richard Robb, Ph.D., Mayo Clinic, have a financial interest in a mapping technology, licensed to St. Jude Medical, that may or may not be used in this research.

Source
St. Jude Medical