Heart Failure - ELEVATE-HFpEF
Prospective, randomized, controlled, double-blinded, multi-center, global, interventional pivotal study evaluating the safety and efficacy of dual chamber personalized pacing compared to minimal or no pacing for the treatment of patients with heart failure with preserved ejection fraction (HFpEF).
This study will evaluate a personalized cardiac pacing rate as a treatment for symptomatic heart failure with preserved ejection fraction (LVEF ≥50%). The intervention is designed to improve health status and other signs and symptoms of heart failure in patients with HFpEF. After enrollment, baseline data will be collected, and subjects will then have a pacemaker implanted. Following successful implant, and prior to pre-hospital discharge, subjects will be randomized 1:1 to one of two study groups. In the first group, subjects will have their pacemaker programmed to dual chamber pacing at a personalized cardiac pacing rate (treatment group) based on their LVEF and height. Subjects randomized to the second group will have their pacemaker programmed to receive ventricular pacing at a non-personalized rate to minimize interference with the subject's intrinsic heart rate (control group).
Criteria:
- Age ≥ 40 years
- EF ≥50% (documented within the past year)
- Recent worsening heart failure episode within the past 12 months (hospitalization or an urgent care visit requiring IV diuretics)
- Stable guideline-directed medical therapy ≥ 30 days
- No previously or currently implanted device (e.g., pacemaker, ICD, CRT)
- No diagnosis of infiltrative cardiomyopathies (e.g., amyloidosis, sarcoidosis) or hypertrophic cardiomyopathies
ClinicalTrials.gov Link: https://clinicaltrials.gov/study/NCT06678841
Sponsor: Medtronic
Location: Hartford Hospital
Contact: Adam Blanchard (860-972-4266) (adam.blanchard@hhchealth.org)