News | September 10, 2014

Medtronic Announces First Implants in Largest-ever, Global Trial of Cardiac Resynchronization Therapy

Post-market clinical trial will assess superiority of the adaptivCRT feature Ccmpared to standard CRT

Medtronic AdaptResponse Global Clinical Trial Cardiac Resynchronization Therapy

September 10, 2014 — Medtronic Inc. announced the first implants in a clinical trial that will compare patient and healthcare system outcomes — including patient mortality and hospitalizations — in heart failure patients who have cardiac resynchronization therapy (CRT) devices with the AdaptivCRT feature enabled versus patients receiving standard CRT. The AdaptResponse trial will assess the superiority of the AdaptivCRT algorithm, which preserves normal heart rhythms and automatically adjusts to patients’ needs to customize therapy; it is expected to be the largest trial of CRT to date, enrolling approximately 3,000 patients worldwide.

The primary endpoint of the AdaptResponse trial is a combination of all-cause mortality and the rate of medical intervention for worsening heart failure (decompensation). The trial also will examine the incidence of atrial fibrillation (AF) in enrolled patients; other secondary endpoints will assess patient quality of life measures as well as cost-effectiveness of CRT devices with the AdaptivCRT feature relative to standard CRT. Patients will receive a CRT-pacemaker or CRT-defibrillator equipped with the AdaptivCRT algorithm, and will be randomized 1:1 to either treatment (aCRT ON) or control (aCRT OFF) groups. Patients will be followed at three and six months after randomization, and then every six months until trial closure.

Patients will be enrolled at up to 200 centers in Europe, Latin America, the Middle East, Australia, Canada, India, Japan, South Korea, Taiwan and the United States. The first implants in the trial were performed by Mark Castellani, M.D., atSparrow Hospital in Lansing, Mich., and by Edward J. Schloss, M.D., at The Christ Hospital in Cincinnati. Bruce Wilkoff, M.D., director of Cardiac Pacing and Tachyarrhythmia Devices at the Cleveland Clinic, is chair of the AdaptResponse trial’s steering committee.

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