Alleviant ALLAY-HF Study
Key facts
- Where
- Aalst, Antwerp, and Bruges, BelgiumSee the 3 sites
Where in Belgium
- OLV HospitalAalst, BelgiumTaking people
- ZAS MiddelheimAntwerp, BelgiumTaking people
- Az Sint Jan BruggeBruges, BelgiumTaking 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
- NCT05685303
- Record updated
- 14 August 2026
- Original description
Prospective, multicenter, randomized, sham-controlled, double blinded, adaptive study designed to evaluate the safety and efficacy of a percutaneously created interatrial shunt using the Alleviant ALV1 System in patients with HFpEF/HFmrEF.Read full original descriptionShow less
Safety and Efficacy of the Alleviant System for No-Implant Interatrial Shunt Creation in Patients With Chronic Heart Failure
Prospective, multicenter, randomized, sham-controlled, double blinded, adaptive study designed to evaluate the safety and efficacy of a percutaneously created interatrial shunt using the Alleviant ALV1 System in patients with HFpEF/HFmrEF.
Inclusion: Symptomatic HFpEF/HFmrEF with LVEF greater than or equal to 40%; NYHA Class II, III or ambulatory IV; Exercise right heart catheterization*; Elevated left atrial pressure during exercise right heart catheterization (greater than or equal to 25 mmHg); Exercise PVR < 1.8 WU; Ongoing stable GDMT.
Exclusion: Advanced heart failure; Evidence of right heart dysfunction; Presence of a pacemaker.