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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.
Posted In: MDT
