ELEVATE-HFpEF
Brief description of study
The purpose of the study is to evaluate the safety and efficacy of dual chamber personalized pacing compared to minimal or no pacing for the treatment of HFpEF. This study will evaluate a personalized cardiac pacing rate as a treatment for symptomatic heart failure with preserved ejection fraction (LVEF ≥50%).
Detailed description of study
After enrollment, participants will have a pacemaker implanted. Following successful implant, and prior to pre-hospital discharge, participants will be randomized 1:1 to one of two study groups. In the first group, participants will have their pacemaker programmed to dual chamber pacing at a personalized cardiac pacing rate (treatment group) based on their LVEF and height. Participants 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).
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Medical Research
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Age: 40 years - 99 years
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Gender: All
Inclusion:
- Documented EF ≥50% within the last 12 months
- Heart failure with preserved ejection fraction (HFpEF) that meets study requirements
- On stable guideline indicated HF medical therapy (Class I recommendations) for at least 30 days
Exclusion:
- Improved or recovered EF (i.e., prior LVEF<50%)
- Patient has a previously implanted, currently implanted, or is planning to get a cardiac implantable electronic device capable of delivering pacing (e.g., pacemaker, implantable cardioverter defibrillator (ICD), cardiac resynchronization therapy (CRT))
- Current pregnancy (requirement for negative pregnancy test may vary)
- Average heart rate <50 bpm or symptomatic bradycardia
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