Medtronic plc has started a global pivotal study to evaluate a new approach to cardiac pacing for patients with heart failure with preserved ejection fraction (HFpEF). The ELEVATE-HFpEF trial will investigate whether elevated and personalized cardiac pacing rates can improve outcomes for this patient group, which currently has limited treatment options.
HFpEF is characterized by stiffening of the heart muscles, leading to reduced blood flow and symptoms such as shortness of breath, irregular heartbeats, chest pain, weakness, and swelling in the legs. The condition affects about 32 million people worldwide and approximately 3 million in the United States. It accounts for around half of all heart failure cases globally, and its prevalence is expected to increase as populations age.
Previous clinical studies have indicated that tailored pacing rates may benefit HFpEF patients who also have bradycardia. The current trial aims to test this method in a broader population using conduction system pacing and individualized settings.
“Millions of people around the world have HFpEF 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 in Fairfax, Virginia, and global co-principal investigator on the ELEVATE-HFpEF trial. “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.”
The randomized, controlled, double-blinded study will enroll up to 700 participants across North America, Europe, Middle East, Africa, Australia, and Asia Pacific. Participants will receive conduction system pacing using Medtronic pacemakers and SelectSecure MRI SureScan Model 3830 leads. Patients’ devices will be programmed either for personalized pacing based on body size and heart function or set as backup if needed. Researchers will follow participants for one year to assess safety and effectiveness.
Initial implant procedures took place at The Alfred Hospital in Melbourne, Australia, and The Ohio State University Wexner Medical Center in Columbus, Ohio. Global co-principal investigators include Dr. Atwater and Harriette Van Spall, M.D., Associate Professor at McMaster University in 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 at 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.”
Medtronic plc is headquartered in Galway, Ireland. The company employs more than 95,000 people across over 150 countries. Its products address about 70 health conditions including cardiac devices among others.
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“Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.”
