Medtronic initiates global pivotal study of cardiac pacing in a new patient population

Rhea-AI Summary

Medtronic (NYSE:MDT) has launched ELEVATE-HFpEF, a global pivotal study investigating a novel cardiac pacing treatment for patients with Heart Failure with preserved Ejection Fraction (HFpEF). The study will evaluate whether personalized elevated pacing rates using conduction system pacing can improve outcomes for HFpEF patients.

The trial will enroll up to 700 participants across multiple regions, using Medtronic's commercially available pacemaker and SelectSecure™ MRI SureScan™ Model 3830 pacing leads. The study targets HFpEF, which affects 32 million people worldwide and represents approximately 50% of heart failure cases. Participants will be followed for one year to assess the efficacy and safety of this investigative treatment.

Positive

• Targeting a large untapped market of 32 million HFpEF patients worldwide
• Potential expansion of pacing therapy into a new patient population with limited treatment options
• Building on promising results from earlier clinical studies suggesting positive impact

Negative

• Long one-year study duration before potential commercialization
• Success of the treatment approach is not guaranteed
• Requires regulatory approval for new indication if successful

Insights

Medical Device Clinical Trial Expert

Medtronic's ELEVATE-HFpEF trial could open significant new market for pacemakers in heart failure patients with limited current options.

Medtronic has launched a potentially groundbreaking global pivotal trial investigating a novel application of their existing pacemaker technology. The ELEVATE-HFpEF study represents a strategic expansion beyond traditional bradycardia (slow heartbeat) indications into the largely underserved heart failure with preserved ejection fraction (HFpEF) population.

This study has substantial market implications given HFpEF affects approximately 32 million patients globally and 3 million in the US - representing about 50% of all heart failure cases. The patient population is expected to grow with the aging demographic trend.

What makes this trial particularly noteworthy is that Medtronic is targeting patients who don't currently qualify for pacemakers under existing guidelines. The company is leveraging their conduction system pacing technology, which more naturally mimics physiologic heart contractions, combined with personalized elevated pacing rates tailored to individual patient characteristics.

The trial design is robust - randomized, controlled, double-blinded, and multi-center - planning to enroll 700 participants globally. If successful, this would create an entirely new indication for Medtronic's existing pacemaker product line, potentially unlocking a substantial new revenue stream without requiring entirely new device development.

This approach is supported by promising earlier clinical evidence from the myPACE trial cited in the release, which showed personalized accelerated pacing rates may benefit HFpEF patients. The current standard medical therapy for HFpEF offers limited symptom relief, creating a significant unmet need that Medtronic aims to address with this repurposed existing technology.

Study to evaluate whether a new approach to pacing the heart can improve the lives of patients with heart failure with preserved ejection fraction (HFpEF) who have limited treatment options today

GALWAY, Ireland, Sept. 15, 2025 /PRNewswire/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced the initiation of a pivotal study evaluating the use of elevated and personalized cardiac pacing rates for the treatment of patients with Heart Failure with preserved Ejection Fraction (ELEVATE-HFpEF, NCT06678841). Physicians routinely use pacing therapy to treat patients whose hearts beat too slowly (bradycardia). This study, however, 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.

HFpEF is a condition when the cardiac muscles stiffen and do not relax properly, causing diminished blood flow and an inability to meet the body's needs. Patients with HFpEF experience shortness of breath (especially during exercise or exertion, or when lying down), fast or irregular heartbeats, chest pain, weakness, and swelling in their lower legs. Researchers estimate that this condition affects around 32 million people worldwide and 3 million in the United States.¹ It represents approximately 50% of the overall heart failure population, and its prevalence is expected to rise with the aging population.²

Earlier clinical studies have suggested that personalized elevated pacing rates could positively impact patient outcomes for those with HFpEF and bradycardia.³ 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.

"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, Fairfax, Va., 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."  

ELEVATE-HFpEF is a randomized, controlled, double-blinded, multi-center, global study that will enroll 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™ MRI SureScan™ Model 3830 pacing leads. Conduction system pacing is a type 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 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 (a measure of how well the heart pumps blood); or to provide backup pacing if needed (control group). Health care 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 The Ohio State University Wexner Medical Center in Columbus, Ohio. 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.

"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 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."

About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE: MDT), visit www.Medtronic.com and follow Medtronic on LinkedIn.

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.

Contacts:
Emily Dornfeld
Public Relations
+1-763-242-8241

Ryan Weispfenning
Investor Relations
+1-763-505-4626

¹ Redfield MM, Borlaug BA. Heart Failure With Preserved Ejection Fraction: A Review. JAMA. 2023 Mar 14;329(10):827-838. doi: 10.1001/jama.2023.2020. PMID: 36917048.
² Hamo, C. E., et al. (2024). "Heart failure with preserved ejection fraction." Nat Rev Dis Primers 10(1): 55.
³ Infeld, M., et al. (2023). "Effect of Personalized Accelerated Pacing on Quality of Life, Physical Activity, and Atrial Fibrillation in Patients With Preclinical and Overt Heart Failure With Preserved Ejection Fraction: The myPACE Randomized Clinical Trial." JAMA Cardiol 8(3): 213–221.

 

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SOURCE Medtronic plc

FAQ

What is the ELEVATE-HFpEF trial by Medtronic (MDT)?

ELEVATE-HFpEF is a global pivotal study evaluating personalized elevated cardiac pacing rates for treating Heart Failure with preserved Ejection Fraction (HFpEF) patients. The study will enroll up to 700 participants across multiple regions.

How many patients could potentially benefit from Medtronic's new HFpEF treatment?

The condition affects approximately 32 million people worldwide, including 3 million in the United States, representing about 50% of the overall heart failure population.

What technology is Medtronic using in the ELEVATE-HFpEF trial?

The study uses Medtronic's commercially available pacemaker and SelectSecure™ MRI SureScan™ Model 3830 pacing leads with conduction system pacing to stimulate natural electrical pathways in the heart.

How long will the Medtronic ELEVATE-HFpEF trial last?

Healthcare providers will follow patients for one year to assess the efficacy and safety of this investigative treatment.

What are the symptoms of HFpEF that Medtronic's study aims to address?

HFpEF patients experience shortness of breath, fast or irregular heartbeats, chest pain, weakness, and swelling in their lower legs due to stiffened cardiac muscles that don't relax properly.