Study Population
- 400-700 randomized (1:1) participants
- Age > 40 years
- HFpEF (EF ≥ 40%)
Healthcare Professionals
Clinical trial
Study Overview
A randomized, double-blinded, sham-controlled, adaptive trial to evaluate the safety and efficacy of the Alleviant System in patients with heart failure with preserved ejection fraction (HFpEF).
Study design
To evaluate the clinical efficacy and safety of the Alleviant System to improve quality of life and reduce heart failure-related symptoms, hospitalizations and outpatient events in patients with HFpEF.
Alleviant System (Treatment)
Sham Control
Primary Composite Endpoint
- Cardiovascular-related death
- Heart failure events
- Kansas City Cardiomyopathy Questionnaire (KCCQ)
Visit www.clinicaltrials.gov (NCT05685303) for additional trial information.
Who should be considered?
Patients who have symptomatic HF or unexplained dyspnea may be candidates for ALLAY-HF.