Tests a no-implant heart shunt device in adults with heart failure
Tests a heart shunt device against a sham procedure in adults with heart failure.
Plain-language title generated from the registry record
Registry title: Alleviant ALLAY-HFrEF Study
Key facts
- Where
- Clayton and Melbourne, AustraliaSee the 2 sites
Where in Australia
- Monash Health Victorian Heart HospitalClayton, AustraliaTaking people
- Alfred HospitalMelbourne, AustraliaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Alleviant Medical, Inc.
- Trial code
- NCT06812533
- Record updated
- 6 October 2026
- Original description
Prospective, multicenter, randomized, sham-controlled, double blind (patient and observer), study designed to evaluate the safety and efficacy of a percutaneously created interatrial shunt using the Alleviant ALV1 System in patients with HFrEF.Read full original descriptionShow less
Safety and Efficacy of the Alleviant No-Implant Interatrial Shunt in Patients With Heart Failure and Reduced Ejection Fraction
Prospective, multicenter, randomized, sham-controlled, double blind (patient and observer), study designed to evaluate the safety and efficacy of a percutaneously created interatrial shunt using the Alleviant ALV1 System in patients with HFrEF.
Inclusion: LVEF ≤ 40%; NYHA class II, III or ambulatory IV HF; Receiving optimal, maximally tolerated, stable GDMT.
Exclusion: Advanced heart failure; Evidence of right heart dysfunction; Life-expectancy < 12 months.