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: 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
Age range: 18 Years
🧪 Interventions in This Study
📋 "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)
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.
More studies in Heart Failure
- REDUCE LAP-HFREF TRIAL — New York, New York
- Comparison Between a Robotic Tele-echo-cardiography Technique and a Standard Echocardiography in the Management of Heart Failure in the Guadeloupe Archipelago Between the University Hospital of Guadeloupe and the Marie-Galante Hospital — Grand-Bourg,
- Physiological Effects Ketone Ester in Heart — Cleveland, Ohio
- Staged Kidney Transplantation During Combined Heart/Kidney Transplantation — Los Angeles, California
- A Research Study Comparing Different Doses of CDR132L With Placebo on the Structure and Function of the Heart in People With Heart Failure With Preserved Ejection Fraction and Left Ventricular Hypertrophy — Birmingham, Alabama
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.