Study of Personalized Dual Chamber Cardiac Pacing for Treating Heart Failure With Preserved Ejection Fraction in Adults 40 and Older

What this Trial Is About

Researchers are evaluating a personalized cardiac pacing therapy for patients with heart failure with preserved ejection fraction HFpEF who have a left ventricular ejection fraction of 50% or higher. This pivotal, global, double-blinded study compares the safety and effectiveness of dual chamber personalized pacing against minimal or no pacing. The goal is to improve health status and heart failure symptoms in these patients. Participants will receive an implanted Medtronic dual chamber pacemaker, either Astra XT or Azure XT models. After implantation, they will be randomly assigned to one of two groups. The treatment group will have their pacemaker programmed to a personalized pacing rate based on their height and baseline heart function, while the control group will have pacing set to minimize interference with their natural heart rate. At 12 months, the control group will switch to the personalized pacing rate. Follow-up visits will occur at 2, 6, 12, 14, 18, and 24 months, with annual visits thereafter until study completion. During the study, participants will complete scheduled visits including assessments of heart failure symptoms, six-minute walk tests, and biomarker measurements like NT-proBNP. Researchers will monitor cardiovascular events, pacemaker-related complications, and physical activity via device data. The primary outcomes focus on a composite of cardiovascular events and changes in patient health status over 12 months. The entire study is expected to last about 4.5 years, with up to two years of enrollment and 18 months of follow-up for each participant.

ELEVATE-HFpEF Clinical Study