Randomized Trial of Personalized Dual Chamber Cardiac Pacing for Treatment of Heart Failure With Preserved Ejection Fraction (ELEVATE-HFpEF)

What this Trial Is About

Researchers are evaluating a personalized cardiac pacing rate as a treatment for patients with symptomatic heart failure with preserved ejection fraction (HFpEF), characterized by a left ventricular ejection fraction (LVEF) of 50% or higher. This prospective, randomized, controlled, double-blinded, multi-center global study aims to assess the safety and effectiveness of dual chamber personalized pacing compared to minimal or no pacing in improving health status and symptoms in HFpEF patients. Participants will receive a qualifying Medtronic dual chamber pacemaker, either Astra XT or Azure XT. After implantation, they will be randomized into two groups: one group will have the pacemaker programmed to deliver dual chamber pacing at a personalized cardiac pacing rate based on their height and baseline LVEF (treatment group), while the other group will receive ventricular pacing at a non-personalized rate designed to minimize interference with their natural heart rate (control group). The control group will switch to personalized pacing after the 12-month visit. Follow-up visits will occur at 2, 6, 12, 14, 18, and 24 months, with annual visits thereafter until the study ends. During the study, participants will undergo data collection at each follow-up visit, including assessments related to cardiovascular mortality, heart failure events, health status questionnaires, six-minute walk tests, and blood biomarker measurements such as NT-proBNP. Safety will be monitored by tracking major complications related to the pacemaker system or procedure over 12 months. Physical activity and atrial fibrillation burden will also be measured by the device. The estimated total study duration spans approximately 4.5 years, including enrollment and follow-up periods.

ELEVATE-HFpEF Clinical Study