Taking people in United StatesNo phase
Tests a no-implant heart shunt device in adults with heart failure
Tests a heart shunt device against a sham procedure in adults with heart failure.
Plain-language title generated from the registry record
Registry title: Alleviant ALLAY-HFrEF Study
Key facts
- Where
- Abilene, Asheville, Austin, Boston, Browns Mills, Charleston, Cleveland, Decatur, Delray Beach, Durham, Englewood, Harrisburg, Houma, Knoxville, Las Vegas, Los Angeles, Minneapolis, Naperville, New Orleans, New York, Pensacola, Plano, Raleigh, Rapid City, Roanoke, Rochester, Sacramento, San Diego, San Francisco, St Louis, Tampa, Temple, Toledo, and Waco, United StatesSee the 40 sites
Where in United States
- Hendrick HealthAbilene, United StatesTaking people
- Mission HospitalAsheville, United StatesTaking people
- Austin HeartAustin, United StatesTaking people
- Texas Cardiac Arrhythmia Research FoundationAustin, United StatesNo longer taking part
- Boston Medical CenterBoston, United StatesTaking people
- Brigham and Women's HospitalBoston, United StatesTaking people
- Tufts Medical CenterBoston, United StatesTaking people
- Deborah Heart & Lung CenterBrowns Mills, United StatesTaking people
- Medical University of South CarolinaCharleston, United StatesTaking people
- Roper St. Francis HealthcareCharleston, United StatesTaking people
- Cleveland ClinicCleveland, United StatesTaking people
- Atlanta VA Health Care SystemDecatur, United StatesTaking people
- Delray Medical CenterDelray Beach, United StatesTaking people
- Duke University HospitalDurham, United StatesTaking people
- Englewood Medical CenterEnglewood, United StatesTaking people
- Pinnacle Health Cardiovascular InstituteHarrisburg, United StatesTaking people
- Cardiovascular Institute of the SouthHouma, United StatesTaking people
- Tennova Healthcare-Turkey Creek Medical CenterKnoxville, United StatesTaking people
- UMC of Southern NevadaLas Vegas, United StatesTaking people
- Keck Medical Center of USCLos Angeles, United StatesTaking people
- University California Los Angeles Medical CenterLos Angeles, United StatesTaking people
- Minneapolis Heart Institute FoundationMinneapolis, United StatesTaking people
- Midwest Cardiovascular InstituteNaperville, United StatesTaking people
- University Medical Center New OrleansNew Orleans, United StatesTaking people
- Stony Brook MedicineNew York, United StatesTaking people
- Ascension Sacred HeartPensacola, United StatesTaking people
- Baylor Scott & White Research InstitutePlano, United StatesTaking people
- NC Heart and Vascular ResearchRaleigh, United StatesTaking people
- Monument HealthRapid City, United StatesTaking people
- Carilion ClinicRoanoke, United StatesTaking people
- Rochester General HospitalRochester, United StatesTaking people
- University of Rochester Medical CenterRochester, United StatesTaking people
- UC Davis Medical CenterSacramento, United StatesTaking people
- Scripps Clinical Research ServicesSan Diego, United StatesTaking people
- University of California San FranciscoSan Francisco, United StatesTaking people
- Washington University St. LouisSt Louis, United StatesTaking people
- Tampa General HospitalTampa, United StatesTaking people
- Baylor Scott & White - TempleTemple, United StatesTaking people
- ProMedica Toledo HospitalToledo, United StatesTaking people
- Waco CardiologyWaco, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Alleviant Medical, Inc.
- Trial code
- NCT06812533
- Record updated
- 6 October 2026
- Original description
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.Read full original descriptionShow less
Safety and Efficacy of the Alleviant No-Implant Interatrial Shunt in Patients With Heart Failure and Reduced Ejection Fraction
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.
Inclusion: LVEF ≤ 40%; NYHA class II, III or ambulatory IV HF; Receiving optimal, maximally tolerated, stable GDMT.
Exclusion: Advanced heart failure; Evidence of right heart dysfunction; Life-expectancy < 12 months.