Medtronic Launches Pivotal Trial Testing Personalized Pacing Therapy for Heart Failure Patients
Key Insights
Medtronic has initiated the ELEVATE-HFpEF (search) pivotal study to evaluate personalized cardiac pacing rates as a novel treatment for heart failure with preserved ejection fraction (HFpEF), a condition affecting 32 million people worldwide.
The randomized, double-blinded trial will enroll up to 700 participants across multiple regions to test conduction system pacing using personalized rates based on body size and heart function.
This represents a potential breakthrough for HFpEF (search) patients who currently have limited treatment options, as traditional pacemakers are not indicated for this condition that affects approximately 50% of all heart failure patients.
Medtronic has launched a global pivotal study investigating whether personalized cardiac pacing therapy can improve outcomes for patients with heart failure with preserved ejection fraction (HFpEF (search)), marking a potential paradigm shift in treating a condition that affects millions worldwide but has limited therapeutic options.
The ELEVATE-HFpEF (search) trial (NCT06678841) represents a novel approach to cardiac pacing, moving beyond the traditional use of pacemakers for patients with slow heart rates (bradycardia) to explore therapeutic benefits for HFpEF patients. The study will evaluate whether elevated and personalized pacing rates using conduction system pacing can improve patient outcomes and heart failure symptoms.
Addressing a Significant Unmet Medical Need
HFpEF (search) occurs when cardiac muscles stiffen and do not relax properly, causing diminished blood flow and an inability to meet the body's needs. Patients experience shortness of breath, particularly during exercise or when lying down, fast or irregular heartbeats, chest pain, weakness, and swelling in their lower legs. The condition affects approximately 32 million people worldwide and 3 million in the United States, representing about 50% of the overall heart failure population. Its prevalence is expected to rise with the aging population.
"Millions of people around the world have HFpEF (search) and experience reduced quality of life and increased risk of hospitalization 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, M.D., cardiac electrophysiologist at Inova Schar Heart and Vascular and global co-principal investigator on the ELEVATE-HFpEF trial.
Study Design and Methodology
The ELEVATE-HFpEF (search) trial is designed as a randomized, controlled, double-blinded, multi-center, global study that will enroll up to 700 participants across 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™ MRI SureScan™ Model 3830 pacing leads.
Conduction system pacing represents an advanced form of pacing therapy that taps into the heart's natural electrical pathways to stimulate a coordinated heartbeat, closely mimicking the heart's physiologic contractions. Physicians will program study patients' pacemakers using one of two approaches: a personalized cardiac pacing rate using an allometric scale based on each individual's body size and baseline left ventricular ejection fraction, or backup pacing as needed for the control group.
Healthcare providers 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 The Ohio State University Wexner Medical Center in Columbus, Ohio.
Scientific Foundation and Clinical Rationale
The trial builds on earlier clinical studies suggesting that personalized elevated pacing rates could positively impact patient outcomes for those with HFpEF (search) and bradycardia. The ELEVATE-HFpEF trial seeks to validate this approach in a broader patient population, using personalized pacing settings and conduction system pacing in patients who do not have a current indication for pacing.
"This pivotal study will provide important insights into the potential of personalized pacing as an innovative approach for improving quality of life and cardiac outcomes for patients living with this serious and often deadly condition," Dr. Atwater noted.
Expanding Pacing Therapy Applications
The study represents a significant expansion of pacing therapy applications beyond traditional indications. Robert C. Kowal, M.D., Ph.D., general manager for Cardiac Pacing Therapies in Medtronic's Cardiac Rhythm Management business, emphasized the historical context: "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."
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.
Medtronic intends to use the study results to pursue a new pacing indication for patients with HFpEF (search), potentially opening a new therapeutic avenue for a patient population that currently has limited clinically proven treatments. The company aims to demonstrate that pacing therapy can serve as a safe and effective intervention to improve the lives of patients with HFpEF, a cardiac condition that pacemakers do not currently treat.