Medtronic has announced the initiation of a pivotal study evaluating the use of elevated and personalised cardiac pacing rates for the treatment of patients with heart failure with preserved ejection fraction (HFpEF).
While physicians routinely use pacing therapy to treat bradycardia patients, the ELEVATE-HFpEF study will investigate a potential novel treatment for patients with HFpEF by using conduction system pacing to improve patient outcomes and heart failure symptoms. Medtronic intends to use the study results to pursue a new pacing indication for patients with HFpEF who currently have limited clinically proven treatments.
Earlier clinical studies have suggested that personalised elevated pacing rates could positively impact patient outcomes for those with HFpEF and bradycardia. The ELEVATE-HFpEF trial seeks to validate this in a broader group, using personalised pacing settings and conduction system pacing in patients who do not have a current indication for pacing.
“Millions of people around the world have HFpEF and experience reduced quality of life and increased risk of hospitalisation and death. For some patients with HFpEF, current medical management alone may not be enough to alleviate their symptoms, and new treatment strategies are needed to improve these outcomes,” said Brett Atwater (Inova Schar Heart and Vascular, Fairfax, USA), global co-principal investigator (PI) on the ELEVATE-HFpEF trial. “This pivotal study will provide important insights into the potential of personalised pacing as an innovative approach for improving quality of life and cardiac outcomes for patients living with this serious and often deadly condition.”
ELEVATE-HFpEF is a global, double-blinded, multicentre randomised controlled study that will enrol up to 700 participants across the North America, Europe, Middle East, Africa, Australia, and Asia-Pacific regions. Study participants will receive conduction system pacing with a commercially available Medtronic pacemaker and SelectSecure magnetic resonance imaging (MRI) SureScan model 3830 pacing leads. Physicians will programme study patients’ pacemakers to either a personalised 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). Healthcare providers participating in the study will follow patients for one year as researchers assess the efficacy and safety of this investigative treatment.
The first study implant procedures were performed at the Alfred Hospital in Melbourne, Australia and at Ohio State University Wexner Medical Center in Columbus, USA. The global co-PIs for the study are Atwater and Harriette Van Spall (McMaster University, Hamilton, 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, 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.”
