Taking people in United StatesNo phase
Alleviant ALLAY-HF Study
Key facts
- Where
- Abilene, Ann Arbor, Asheville, Austin, Baltimore, Boston, Brighton, Charleston, Chicago, Cleveland, Colombia, Dallas, Decatur, Detroit, Durham, Edgewood, Gainesville, Germantown, Harrisburg, Hartford, Houma, Indianapolis, Jacksonville, Knoxville, Las Vegas, Long Beach, Milwaukee, Minneapolis, Naperville, Naples, New Orleans, New York, Oklahoma City, Orlando, Pensacola, Phoenix, Plano, Portland, Raleigh, Rapid City, Roslyn, Sacramento, San Diego, San Francisco, Santa Barbara, Scottsdale, Seattle, Springfield, St Louis, Stony Brook, Toledo, Tucson, and Waco, United StatesSee the 56 sites
Where in United States
- Hendrick HealthAbilene, United StatesTaking people
- VA Ann ArborAnn Arbor, United StatesTaking people
- Mission HospitalAsheville, United StatesTaking people
- Austin HeartAustin, United StatesTaking people
- Johns Hopkins Medical InstitutionBaltimore, United StatesTaking people
- Boston Medical CenterBoston, United StatesTaking people
- Brigham and Women's HospitalBoston, United StatesTaking people
- Steward St. Elizabeth's Medical CenterBrighton, United StatesNo longer taking part
- Medical University of South CarolinaCharleston, United StatesTaking people
- Advocate Illinois Masonic Medical CenterChicago, United StatesNo longer taking part
- Cleveland ClinicCleveland, United StatesTaking people
- Prisma Health - MidlandsColombia, United StatesTaking people
- UT SouthwesternDallas, United StatesTaking people
- Atlanta VA Health Care SystemDecatur, United StatesTaking people
- Ascension St. John HospitalDetroit, United StatesNo longer taking part
- Duke University HospitalDurham, United StatesTaking people
- St. Elizabeth HealthcareEdgewood, United StatesTaking people
- The Cardiac and Vascular Institute (TCAVI)Gainesville, United StatesTaking people
- Stern Cardiovascular FoundationGermantown, United StatesTaking people
- Pinnacle Health Cardiovascular InstituteHarrisburg, United StatesTaking people
- Hartford HospitalHartford, United StatesNo longer taking part
- Cardiovascular Institute of the SouthHouma, United StatesTaking people
- Indiana UniversityIndianapolis, United StatesTaking people
- HCA Florida Memorial HospitalJacksonville, United StatesTaking people
- Tennova Healthcare-Turkey Creek Medical CenterKnoxville, United StatesTaking people
- UMC of Southern NevadaLas Vegas, United StatesTaking people
- Memorial Care Long Beach Medical CenterLong Beach, United StatesTaking people
- Advocate Aurora Health/Aurora Research InstituteMilwaukee, United StatesNo longer taking part
- Minneapolis Heart Institute FoundationMinneapolis, United StatesTaking people
- Midwest Cardiovascular InstituteNaperville, United StatesTaking people
- NCH Research InstituteNaples, United StatesTaking people
- University Medical Center New OrleansNew Orleans, United StatesTaking people
- New York UniversityNew York, United StatesTaking people
- Lenox Hill HospitalNew York, United StatesNo longer taking part
- VA NY Harbor Healthcare SystemNew York, United StatesNo longer taking part
- South Oklahoma Heart Research LLCOklahoma City, United StatesTaking people
- Advent Health OrlandoOrlando, United StatesTaking people
- Ascension Sacred HeartPensacola, United StatesTaking people
- Arizona Cardiovascular Research CenterPhoenix, United StatesNo longer taking part
- Baylor Scott & White Research InstitutePlano, United StatesTaking people
- Providence St. Vincent's Medical CenterPortland, United StatesNo longer taking part
- NC Heart and Vascular ResearchRaleigh, United StatesTaking people
- Monument HealthRapid City, United StatesTaking people
- St. Francis HospitalRoslyn, United StatesNo longer taking part
- UC Davis Medical CenterSacramento, United StatesTaking people
- Scripps Clinical Research ServicesSan Diego, United StatesTaking people
- University of California San FranciscoSan Francisco, United StatesTaking people
- Santa Barbara Cottage HospitalSanta Barbara, United StatesTaking people
- HonorHealthScottsdale, United StatesNo longer taking part
- University of WashingtonSeattle, United StatesNo longer taking part
- Prairie Education And Research CooperativeSpringfield, United StatesNo longer taking part
- Washington University St. LouisSt Louis, United StatesTaking people
- Stony Brook MedicineStony Brook, United StatesTaking people
- ProMedica Toledo HospitalToledo, United StatesTaking people
- PIMA Heart and VascularTucson, 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
- NCT05685303
- Record updated
- 14 August 2026
- Original description
Prospective, multicenter, randomized, sham-controlled, double blinded, adaptive study designed to evaluate the safety and efficacy of a percutaneously created interatrial shunt using the Alleviant ALV1 System in patients with HFpEF/HFmrEF.Read full original descriptionShow less
Safety and Efficacy of the Alleviant System for No-Implant Interatrial Shunt Creation in Patients With Chronic Heart Failure
Prospective, multicenter, randomized, sham-controlled, double blinded, adaptive study designed to evaluate the safety and efficacy of a percutaneously created interatrial shunt using the Alleviant ALV1 System in patients with HFpEF/HFmrEF.
Inclusion: Symptomatic HFpEF/HFmrEF with LVEF greater than or equal to 40%; NYHA Class II, III or ambulatory IV; Exercise right heart catheterization*; Elevated left atrial pressure during exercise right heart catheterization (greater than or equal to 25 mmHg); Exercise PVR < 1.8 WU; Ongoing stable GDMT.
Exclusion: Advanced heart failure; Evidence of right heart dysfunction; Presence of a pacemaker.