RecruitingHeart Failure With Preserved Ejection Fraction (HFpEF)

ELEVATE-HFpEF Clinical Study

Eligible age

40+ yrs

Accepts

All genders

Locations

22 states

Healthy volunteers

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About this study

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).

Sponsor: Medtronic Cardiac Rhythm and Heart Failure

You may qualify if…

✓ 1. Age ≥ 40 years
✓ 2. Documented EF ≥50% within the preceding 12 months
✓ 3. HFpEF defined as:
✓ 1. 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
✓ 2. Dyspnea on exertion and New York Heart Association (NYHA) ≥ class II symptoms AND AT LEAST ONE OF THE FOLLOWING CRITERIA:
✓ Interstitial / pulmonary edema on prior chest imaging in the last year AND current loop diuretic use for heart failure
✓ Elevated NT-proBNP in the last year defined as \>400 pg/m for patients with no AF or paroxysmal AF, or \>900 pg/ml for patients with ≥persistent AF
✓ Mean pulmonary capillary wedge pressure (PCWP) ≥15 mm Hg or LVEDP ≥16 mm Hg at rest on cardiac catheterization OR pulmonary artery diastolic and wedge pressure (PADP) ≥15 mm Hg at rest on implantable monitor (e.g., CardioMEMs)

You may not qualify if…

✕ 1. Improved or recovered EF (i.e., prior LVEF\<50%)
✕ 2. 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))
✕ 3. Current pregnancy (requirement for negative pregnancy test may vary by jurisdiction)
✕ 4. Average heart rate \<50 bpm or symptomatic bradycardia
✕ 5. Acute coronary syndrome (including MI), cardiovascular surgery, or urgent percutaneous coronary intervention (PCI) within the 3 months prior to baseline visit or an elective PCI within 30 days prior to baseline visit.
✕ 6. Current acute decompensated HF requiring intravenous diuretics, vasodilators and/or inotropic drugs.
✕ 7. Severe obesity defined as BMI \>45.
✕ 8. Persistent, long-standing persistent, or permanent atrial fibrillation (AF) with an average heart rate \<50 bpm or evidence of ventricular pauses exceeding 6 seconds