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Alleviant ALLAY-HFrEF Study
Recruiting
Safety and Efficacy of the Alleviant No-Implant Interatrial Shunt in Patients With Heart Failure and Reduced Ejection Fraction
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria:
* LVEF ≤ 40%
* NYHA class II, III or ambulatory IV HF
* Receiving optimal, maximally tolerated, stable GDMT
Exclusion Criteria:
* Advanced heart failure
* Life-expectancy \< 12 months
* Evidence of right heart dysfunction
About the study
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.
What is being tested
- Alleviant ALV1 System (device)
- Sham-Control (other)
Sponsor: Alleviant Medical, Inc. · Participants: 350 · Started: Mar 10, 2025
Contact the study team
Official record on ClinicalTrials.gov — NCT06812533
Locations in the U.S.
| California | Keck Medical Center of USC, Los Angeles
University California Los Angeles Medical Center, Los Angeles
UC Davis Medical Center, Sacramento
Scripps Clinical Research Services, San Diego
University of California San Francisco, San Francisco |
| Florida | Delray Medical Center, Delray Beach
Ascension Sacred Heart, Pensacola
Tampa General Hospital, Tampa |
| Georgia | Atlanta VA Health Care System, Decatur |
| Illinois | Midwest Cardiovascular Institute, Naperville |
| Louisiana | Cardiovascular Institute of the South, Houma
University Medical Center New Orleans, New Orleans |
| Massachusetts | Boston Medical Center, Boston
Brigham and Women's Hospital, Boston
Tufts Medical Center, Boston |
| Minnesota | Minneapolis Heart Institute Foundation, Minneapolis |
| Missouri | Washington University - St Louis, St Louis |
| Nevada | UMC of Southern Nevada, Las Vegas |
| New Jersey | Deborah Heart & Lung Center, Browns Mills
Englewood Medical Center, Englewood |
| New York | Stony Brook Medicine, New York
Rochester General Hospital, Rochester
University of Rochester Medical Center, Rochester (Not yet recruiting) |
| North Carolina | Mission Hospital, Asheville
Duke University Hospital, Durham
NC Heart and Vascular Research, Raleigh |
| Ohio | Cleveland Clinic, Cleveland
ProMedica Toledo Hospital, Toledo |
| Pennsylvania | Pinnacle Health Cardiovascular Institute, Harrisburg |
| South Carolina | Medical University of South Carolina, Charleston
Roper St. Francis Healthcare, Charleston |
| South Dakota | Monument Health, Rapid City |
| Tennessee | Tennova Healthcare - Turkey Creek Medical Center, Knoxville |
| Texas | Hendrick Health, Abilene
Austin Heart, Austin
Baylor Scott & White Research Institute, Plano
Baylor Scott & White - Temple, Temple
Waco Cardiology, Waco |
| Virginia | Carilion Clinic, Roanoke |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.