Medtronic has begun a pivotal study evaluating its elevated and personalized cardiac pacing rates to treat heart failure with preserved ejection fraction (ELEVATE-HPpEF).

The study will investigate a possible novel treatment for HFpEF patients by using conduction system pacing to improve outcomes and heart failure symptoms. Medtronic plans to use the study’s results to chase a new pacing indication for HFpEF patients who currently have limited clinically proven treatments.

Earlier clinical studies suggest that personalized elevated pacing rates could positively impact outcomes for patients with HFpEF and bradycardia. The ELEVATE-HFpEF trial aims to validate this in a larger group, using personalized pacing settings and conduction system pacing in patients without a current indication for pacing.

The randomized, controlled, double-blinded, multi-center, global study will enroll up to 700 participants across the North America, Europe, Middle East, Africa, Australia, and Asia Pacific regions. Participants will receive conduction system pacing with a commercially available Medtronic pacemaker and SelectSure MRI SureScan Model 3830 pacing leads.

Conduction system pacing taps into the heart’s natural electrical pathways to stimulate a coordinated heartbeat, mimicking the heart’s physiologic contractions. Physicians will program study patients’ pacemakers to either a personalized cardiac pacing rate using an allometric scale based on body size, and baseline left ventricular ejection fraction. Patients will be followed for one year to assess the investigative treatment.

The first study implant procedures were performed at The Alfred Hospital in Melbourne, Australia and at The Ohio State University Wexner Medical Center in Columbus, Ohio. The global co-principal investigators for the study are Dr. Atwater and Harriette Van Spall, M.D., Associate Professor of Medicine at McMaster University, Canada, and Director of Implementation Science at Baim Institute for Clinical Research, Hamilton, Ontario, Canada.

“Since Medtronic invented the first battery-powered pacemaker nearly 70 years ago, we have continually worked with physician and patient communities to both innovate new pacing technology and deliver landmark clinical evidence to broaden the types of patients that may benefit from pacing,” said Robert C. Kowal, M.D., Ph.D., general manager for Cardiac Pacing Therapies in the Cardiac Rhythm Management business, which is part of the Medtronic Cardiovascular Portfolio. “With the initiation of this study, we are opening the door to our next era—pacing therapy as a potentially safe and effective intervention to improve the lives of patients with HFpEF, a cardiac condition that pacemakers do not currently treat.”