Study Population
- Approx. 350 randomized (1:1) participants
- Age ≥ 18 years
- HFrEF (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 reduced ejection fraction (HFrEF).
Study design
To evaluate the clinical efficacy and safety of the Alleviant System to reduce heart failure-related symptoms, hospitalizations and outpatient events in patients with HFrEF.
Alleviant System (Treatment)
Sham Control
Primary Composite Endpoint
- All-cause mortality or cardiac transplant or LVAD
- Heart failure events
Visit www.clinicaltrials.gov (NCT06812533) for additional trial information.
Who should be considered?
Patients who have symptomatic HF may be candidates for ALLAY-HFrEF.