Alleviant ALLAY-HF Study
Eligible age
40+ yrs
Accepts
All genders
Locations
27 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: Alleviant Medical, Inc.
You may qualify if…
- ✓ 1. Symptomatic HFpEF/HFmrEF with LVEF greater than or equal to 40%
- ✓ 2. NYHA Class II, III or ambulatory IV
- ✓ 3. Exercise right heart catheterization\*
- ✓ 1. Elevated left atrial pressure during exercise right heart catheterization (greater than or equal to 25 mmHg)
- ✓ 2. Exercise PVR \< 1.8 WU
- ✓ 4. Ongoing stable GDMT
You may not qualify if…
- ✕ 1. Advanced heart failure
- ✕ 2. Presence of a pacemaker
- ✕ 3. Evidence of right heart dysfunction
Where it's recruiting
Phoenix · Scottsdale · Tucson
Long Beach · Sacramento · San Diego · San Francisco …
Hartford
Gainesville · Jacksonville · Naples · Orlando …
Decatur
Chicago · Naperville · Springfield
Indianapolis
Edgewood
Houma · New Orleans
Baltimore
Boston · Brighton
Ann Arbor · Detroit · Rozzano
Source: ClinicalTrials.gov · NCT05685303 · last updated 2026-08-14