RecruitingRecruiting
Alleviant ALLAY-HFrEF Study
NCT06812533 · Alleviant Medical, Inc.
In plain English
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Official title
Safety and Efficacy of the Alleviant No-Implant Interatrial Shunt in Patients With Heart Failure and Reduced Ejection Fraction
About this 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.
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
Study design
Enrollment target: 350 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2025-03-10
Estimated completion: 2028-12
Last updated: 2026-09-16
Interventions
Device: Alleviant ALV1 SystemOther: Sham-Control
Primary outcomes
- • Composite Primary Endpoint (12-Month)
Sponsor
Alleviant Medical, Inc. · industry
Contacts & investigators
ContactStacia Kraus · contact · stacia.kraus@alleviantmedical.com · 612-387-4552
InvestigatorGregg Stone · principal_investigator, Icahn School of Medicine at Mount Sinai
InvestigatorJames Udelson · principal_investigator, Tufts Medical Center
All locations (68)
Keck Medical Center of USCRecruiting
Los Angeles, California, United States
University California Los Angeles Medical CenterRecruiting
Los Angeles, California, United States
UC Davis Medical CenterRecruiting
Sacramento, California, United States
Scripps Clinical Research ServicesRecruiting
San Diego, California, United States
University of California San FranciscoRecruiting
San Francisco, California, United States
Delray Medical CenterRecruiting
Delray Beach, Florida, United States
Ascension Sacred HeartRecruiting
Pensacola, Florida, United States
Tampa General HospitalRecruiting
Tampa, Florida, United States
Atlanta VA Health Care SystemRecruiting
Decatur, Georgia, United States
Midwest Cardiovascular InstituteRecruiting
Naperville, Illinois, United States
Cardiovascular Institute of the SouthRecruiting
Houma, Louisiana, United States
University Medical Center New OrleansRecruiting
New Orleans, Louisiana, United States
Tufts Medical CenterRecruiting
Boston, Massachusetts, United States
Brigham and Women's HospitalRecruiting
Boston, Massachusetts, United States
Boston Medical CenterRecruiting
Boston, Massachusetts, United States
Minneapolis Heart Institute FoundationRecruiting
Minneapolis, Minnesota, United States
Washington University - St LouisRecruiting
St Louis, Missouri, United States
UMC of Southern NevadaRecruiting
Las Vegas, Nevada, United States
Deborah Heart & Lung CenterRecruiting
Browns Mills, New Jersey, United States
Englewood Medical CenterRecruiting
Englewood, New Jersey, United States
Stony Brook MedicineRecruiting
New York, New York, United States
Rochester General HospitalRecruiting
Rochester, New York, United States
University of Rochester Medical CenterNot Yet Recruiting
Rochester, New York, United States
Mission HospitalRecruiting
Asheville, North Carolina, United States
Duke University HospitalRecruiting
Durham, North Carolina, United States
NC Heart and Vascular ResearchRecruiting
Raleigh, North Carolina, United States
Cleveland ClinicRecruiting
Cleveland, Ohio, United States
ProMedica Toledo HospitalRecruiting
Toledo, Ohio, United States
Pinnacle Health Cardiovascular InstituteRecruiting
Harrisburg, Pennsylvania, United States
Roper St. Francis HealthcareRecruiting
Charleston, South Carolina, United States
Medical University of South CarolinaRecruiting
Charleston, South Carolina, United States
Monument HealthRecruiting
Rapid City, South Dakota, United States
Tennova Healthcare - Turkey Creek Medical CenterRecruiting
Knoxville, Tennessee, United States
Hendrick HealthRecruiting
Abilene, Texas, United States
Texas Cardiac Arrhythmia Research FoundationTerminated
Austin, Texas, United States
Austin HeartRecruiting
Austin, Texas, United States
Baylor Scott & White Research InstituteRecruiting
Plano, Texas, United States
Baylor Scott & White - TempleRecruiting
Temple, Texas, United States
Waco CardiologyRecruiting
Waco, Texas, United States
Carilion ClinicRecruiting
Roanoke, Virginia, United States
Monash Health Victorian Heart HospitalRecruiting
Clayton, Victoria, Australia
Alfred HospitalRecruiting
Melbourne, Victoria, Australia
OLV HospitalRecruiting
Aalst, Belgium
ZAS MiddelheimRecruiting
Antwerp, Belgium
AZ Sint Jan BruggeRecruiting
Bruges, Belgium
Southlake Regional Hospital CentreRecruiting
Newmarket, Ontario, Canada
Centre hospitalier de l'Universite de Montreal (CHUM)Recruiting
Montreal, Quebec, Canada
Centre Integre Universitaire de Sainte et de Services Scoiiaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CIUSSS de l'Estrie - CHUS)Recruiting
Montreal, Quebec, Canada
IUCPQ - Université Laval (Quebec)Recruiting
Québec, Canada
Tbilisi Heart and VascularRecruiting
Tbilisi, Georgia
Hippocration General Hospital AthensRecruiting
Athens, Greece
Hygeia HospitalRecruiting
Athens, Greece
European Interbalken Medical CenterRecruiting
Thessaloniki, Greece
Tel Aviv Sourasky Medical CenterRecruiting
Tel Aviv, Israel
Shamir Medical CenterRecruiting
Zrifin, Israel
ChristChurch HospitalRecruiting
Christchurch, New Zealand
Dunedin HospitalRecruiting
Dunedin, New Zealand
University Clinical Hospital in OpoleRecruiting
Opole, Poland
Narodowy Instytut Kardiologii im. Stefana kardynała WyszyńskRecruiting
Warsaw, Poland
Uniwesytecki Szpital KlinicznyRecruiting
Wroclaw, Poland
Hospital Universitario A CorunaRecruiting
A Coruña, Spain
Hospital de la Santa Creu i Sant PauRecruiting
Barcelona, Spain
Hospital Clinic de BarcelonaRecruiting
Barcelona, Spain
Vall d'Hebron University Hospital BarcelonaRecruiting
Barcelona, Spain
Hospital Universitario 12 de OctubreTerminated
Madrid, Spain
Hospital Universitario Puerta de HierroRecruiting
Madrid, Spain
Hospital Clínico Universitario de SalamancaRecruiting
Salamanca, Spain
Valencia Hospital ClinicoRecruiting
Valencia, Spain