Medtronic Initiates Global ELEVATE-HFpEF Pivotal Study of Cardiac Pacing

September 15, 2025—Medtronic announced the initiation of the ELEVATE-HFpEF pivotal study evaluating the use of elevated and personalized cardiac pacing rates for the treatment of patients with heart failure with preserved ejection fraction (HFpEF).

According to the company, the clinical study will investigate a potential treatment for patients with HFpEF by using conduction system pacing to improve patient outcomes and heart failure symptoms as an alternative to pacing therapy to treat bradycardia. The company intends to use the study results to pursue a new pacing indication for patients with HFpEF who currently have limited clinically proven treatments.

Medtronic advised that ELEVATE-HFpEF is a randomized, controlled, double-blinded, multicenter, global study that will enroll up to 700 patients across the North America, Europe, Middle East, Africa, Australia, and Asia Pacific regions. Patients in the study will receive conduction system pacing with a commercially available Medtronic pacemaker and SelectSecure MRI SureScan Model 3830 pacing leads.

The first study implantation procedures were performed at The Alfred Hospital in Melbourne, Australia and at The Ohio State University Wexner Medical Center in Columbus, Ohio.

The global coprincipal investigators for the ELEVATE-HFpEF trial are Brett Atwater, MD, and Harriette Van Spall, MD.

The company noted that earlier clinical studies have suggested that personalized elevated pacing rates could positively impact outcomes for patients with HFpEF and bradycardia. The ELEVATE-HFpEF trial seeks to validate this in a broader group, using personalized pacing settings and conduction system pacing in patients who do not have a current indication for pacing.

Physicians will program study patients’ pacemakers to either a personalized cardiac pacing rate using an allometric scale, which is based on each individual’s body size, and baseline left ventricular ejection fraction; or to provide backup pacing if needed (control group). The patients in the study will be followed for 1 year to assess the efficacy and safety of this investigative treatment, stated Medtronic.