🏛️ Verified NIH Record • Updated 2026-08-12
Alleviant ALLAY-HFrEF Study (NCT06812533)
🟢 Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Alleviant Medical, Inc.
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (4 items).
Location: Keck Medical Center of USC — Los Angeles, California
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Advanced heart failure
- Life-expectancy \< 12 months
- Evidence of right heart dysfunction
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (67 Sites)
- Keck Medical Center of USC — Los Angeles, California
- University California Los Angeles Medical Center — Los Angeles, California
- UC Davis Medical Center — Sacramento, California
- Scripps Clinical Research Services — San Diego, California
- University of California San Francisco — San Francisco, California
- Delray Medical Center — Delray Beach, Florida
- Ascension Sacred Heart — Pensacola, Florida
- Tampa General Hospital — Tampa, Florida
- Atlanta VA Health Care System — Decatur, Georgia
- Midwest Cardiovascular Institute — Naperville, Illinois
- Cardiovascular Institute of the South — Houma, Louisiana
- University Medical Center New Orleans — New Orleans, Louisiana
- Tufts Medical Center — Boston, Massachusetts
- Brigham and Women's Hospital — Boston, Massachusetts
- Boston Medical Center — Boston, Massachusetts
- Minneapolis Heart Institute Foundation — Minneapolis, Minnesota
- Washington University - St Louis — St Louis, Missouri
- UMC of Southern Nevada — Las Vegas, Nevada
- Deborah Heart & Lung Center — Browns Mills, New Jersey
- Englewood Medical Center — Englewood, New Jersey
- Stony Brook Medicine — New York, New York
- Rochester General Hospital — Rochester, New York
- Mission Hospital — Asheville, North Carolina
- Duke University Hospital — Durham, North Carolina
- NC Heart and Vascular Research — Raleigh, North Carolina
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.