FDAnews Device Daily Bulletin
Medical Devices / Postmarket Safety

Medtronic Launches AdaptResponse CRT Trail

Aug. 29, 2014

Clinical investigators have performed the first implants in Medtronic’s AdaptResponse cardiac resynchronization therapy trial, the company said Wednesday. The trial, which will eventually involve 3,000 patients, is the largest study of CRT for heart failure to date, Medtronic says.

The global postmarket study will compare patient and healthcare system outcomes — including patient mortality and hospitalizations — in patients with devices that use the company’s proprietary AdaptivCRT algorithm versus those with standard CRT. It will also look at rates of atrial fibrillation in enrollees and assess AdaptivCRT’s cost-effectiveness and impact on quality of life.

The AdaptivCRT algorithm gives CRT devices the ability to preserve normal heart rhythms and automatically adjust to patients’ needs.

The study will involve up to 200 centers in Europe, Latin America, the Middle East, Australia, Canada, India, Japan, South Korea, Taiwan and the U.S. Patients will be followed at three and six months after randomization, and then every six months until trial closure, Medtronic said.

AdaptivCRT has been featured in Medtronic’s most recent CRT devices, including the Viva Quad XT CRT-D and the Aug. 25 launch of the Viva CRT-P.  — Kellen Owings

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