Alleviant ALLAY-HFrEF Study (NCT06812533)
Safety and Efficacy of the Alleviant No-Implant Interatrial Shunt in Patients With Heart Failure and Reduced Ejection Fraction
🩺 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: Review the eligibility criteria below.
Location: Keck Medical Center of USC — Los Angeles, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (67 Sites)
Showing the first 25 of 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
📞 Contact the Study Coordinator
Phone: (612) 387-4552
Email: stacia.kraus@alleviantmedical.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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.
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Explore by condition: All Heart Failure clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.