Medtronic (NYSE: MDT) announced today that it initiated a pivotal study evaluating the use of cardiac pacing rates in a new patient population.
ELEVATE-HFpEF evaluates elevated, personalized cardiac pacing rates for the treatment of heart failure with preserved ejection fraction (HFpEF).
Medtronic says physicians routinely use pacing to treat hearts that beat to slowly (bradycardia). This study investigates a potential novel treatment for HFpEF by using conduction system pacing to improve outcomes and symptoms. Conduction system pacing taps into the heart’s natural electrical pathways to mimic the heart’s physiologic contractions.
The medtech giant intends to use the results to pursue a new pacing indication for HFpEF. It cited limited availability of clinically proven treatments for this population.
HFpEF occurs when cardiac muscles stiffen and fail to relax properly. This leads to diminished blood flow and an inability to meet the body’s needs. According to Medtronic, HFpEF patients often experience shortness of breath, fast or irregular heartbeats, chest pain, weakness and swelling in their lower legs. The company said researchers estimate that it affects about 32 million people worldwide — 3 million in the U.S. — making up about 50% of the HF population.
Medtronic said earlier clinical studies suggest that personalized elevated pacing could positively impact outcomes. It says this rings true for both HFpEF and bradycardia. The company hopes for the trial to validate this in a broader group.
ELEVATE-HFpEF expects to enroll up to 700 participants across the North America, Europe, Middle East, Africa, Australia and Asia Pacific regions. Participants receive a commercially available Medtronic pacemaker and SelectSure MRI SureScan Model 3830 pacing leads.
Investigators intend to program pacemakers to either a personalized rate or backup pacing (control). They plan to follow patients for one year. The first implants took place at The Alfred Hospital in Melbourne, Australia and at The Ohio State University Wexner Medical Center in Columbus, Ohio.
“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 Dr. Robert C. Kowal, GM for Cardiac Pacing Therapies at Medtronic. “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.”
