Sep 14, 2004
Guidant Announces Enrollment Completion for Largest Clinical Trial to Study Right Ventricular Pacing

International Trial Will Study Unnecessary Pacing in Heart Failure Patients

Indianapolis, Ind. And St. Paul, Minn. - Guidant Corporation (NYSE: GDT) today announced that it has completed enrollment in a major clinical trial to study unnecessary pacing in heart failure patients. Results from previous trials demonstrate that without careful attention to minimizing unnecessary right ventricular pacing the heart''s natural rhythm may be disrupted with some patients experiencing worsened heart failure and increased hospitalizations.

The Guidant-sponsored trial is designed to demonstrate the efficacy and value of a proprietary feature that minimizes unnecessary right ventricular pacing in patients who received a Guidant dual-chamber implantable cardioverter defibrillator. The trial is called Inhibition of Unnecessary Right Ventricular Pacing with AV Search Hysteresis in implantable defibrillators (INTRINSIC RV).

"Guidant has long recognized that minimizing unnecessary device therapy, especially unnecessary right ventricular pacing, is a clinical imperative. Since June 2000, all Guidant dual-chamber implantable defibrillators include a proprietary feature called AV Search Hysteresis," said Joseph Smith, M.D., Ph.D., FACC, chief medical officer, Cardiac Rhythm Management, Guidant Corporation. "The INTRINSIC RV study is designed to bring forth scientific evidence of just how successful this feature is at minimizing unnecessary right ventricular pacing while preserving all of the benefits of dual chamber diagnosis and therapy."

A dual-chamber implantable cardioverter defibrillator can pace and/or sense in two chambers of the heart. One lead is placed in the right atrium (upper chamber); the other is placed in the right ventricle (lower chamber). Dr. Brian Olshansky yesterday presented an abstract of the INTRINSIC trial at the Heart Failure Society of America conference in Toronto, Canada.

"Unnecessary right ventricular pacing is a challenge for physicians," said Brian Olshansky, M.D., professor of Electrophysiology at the University of Iowa and principal investigator of INTRINSIC RV. "Single chamber implantable defibrillators can reduce unnecessary right ventricular pacing, however, I want my patients to receive all the benefits of a more sophisticated dual-chamber implantable defibrillator."

INTRINSIC RV is a multicenter, randomized trial including more than 1,500 patients at 114 centers in the United States, Germany, Italy and Australia. The trial evaluates Guidant-exclusive technology to reduce unnecessary right ventricular pacing in dual-chamber implantable cardioverter defibrillators. The AV Search Hysteresis function included in Guidant implantable cardioverter defibrillators prevents right ventricular pacing if the heart''s natural rhythm is detected. The INTRINSIC RV study, launched in May of 2003, uses the Guidant VITALITY® AVT system. Guidant expects to report full results in mid 2005.