Safety and Efficacy of the Alleviant No-Implant Interatrial Shunt in Patients with Heart Failure and Reduced Ejection Fraction (NCT06812533)

This study is to evaluate the safety and efficacy of the Alleviant ALV1 System in patients with reduced ejection fraction (HFrEF), who remain symptomatic despite optimal maximally tolerated guideline directed medical therapy (GDMT).

Trial phase

Phase 2

Trial participation type

This trial has been designed for the Clinical Research of a Device.

Principal investigator

Prof David Kaye

Key inclusion data

Key Inclusion: 1. Symptomatic heart failure (HF) with reduced ejection fraction (LVEF ? 40%) (site-determined via study-specific TTE); 2. Age ? 18 years; 3. NYHA class II, III or ambulatory IV HF; 4. Receiving optimal, maximally tolerated, stable guideline-directed medical therapy (GDMT) for heart failure, which refers to those HF drugs and devices carrying a class I indication. Key Exclusion: 1. Advanced HF; 2. Clinically significant untreated coronary artery disease (CAD) or carotid artery stenosis that is likely to require intervention within 1 year; 3. Stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT) or thromboembolic episode within 6 months of consent; 4. Uncontrolled tachyarrhythmias, including defibrillation shocks reported by the patient within 30 days prior to consent. Refer to protocol for further details.