ELEVATE-HFpEF Clinical 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).

Inclusion Criteria: 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) * Echo criteria defined by ≥2 of: * LV wall thickness ≥ 12 mm * LV mass index (BSA indexed LVH): sex at birth male \>115 g/m2, sex at birth female \>95 g/m2 * Relative wall thickness ≥0.42 * E/e' ≥15 in sinus rhythm (or \> 11 in the setting of atrial fibrillation) OR septal \