ELEVATE-HFpEF Clinical Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorMedtronic Cardiac Rhythm and Heart Failure
About this trial
ELEVATE-HFpEF is a 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).
Eligibility criteria
Qualifiers
Age ≥ 40 years
Documented EF ≥50% within the preceding 12 months
Documented worsening HF episode (either HF hospitalization or documented urgent clinic visit for HF with intravenous diuretics) within 12-months prior to baseline visit OR
Interstitial / pulmonary edema on prior chest imaging in the last year AND current loop diuretic use for heart failure
Disqualifiers
Improved or recovered EF (i.e., prior LVEF<50%)
Patient has a previously implanted, currently implanted, or is intended to have implanted 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 by jurisdiction)
Average heart rate <50 bpm or symptomatic bradycardia
Trial design
Treatments tested in this trial
- Personalized cardiac pacing
Treatment groups
700 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov