Health Trials

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 groups

Locations

46
Australia
The Prince Charles Hospital4032, ChermsideQueensland, Australia
The Alfred Hospital3004, MelbourneVictoria, Australia
Austria
Ordensklinikum Linz GmbH / Elisabethinen4010, Linz Austria
Belgium
Universitair Ziekenhuis Antwerpen2650, Edegem Belgium

Sponsors and collaborators

Medtronic Cardiac Rhythm and Heart Failure

Lead sponsor

Source ClinicalTrials.gov