RecruitingRecruiting
Alleviant ALLAY-HF Study
NCT05685303 · Alleviant Medical, Inc.
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Safety and Efficacy of the Alleviant System for No-Implant Interatrial Shunt Creation in Patients With Chronic Heart Failure
About this study
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.
Eligibility criteria
Inclusion Criteria:
1. Symptomatic HFpEF/HFmrEF with LVEF greater than or equal to 40%
2. NYHA Class II, III or ambulatory IV
3. Exercise right heart catheterization\*
1. Elevated left atrial pressure during exercise right heart catheterization (greater than or equal to 25 mmHg)
2. Exercise PVR \< 1.8 WU
4. Ongoing stable GDMT
Exclusion Criteria:
1. Advanced heart failure
2. Presence of a pacemaker
3. Evidence of right heart dysfunction
Study design
Enrollment target: 700 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2023-01-10
Estimated completion: 2032-12-01
Last updated: 2026-08-14
Interventions
Device: Alleviant ALV1 SystemOther: Sham-Control
Primary outcomes
- • Composite Primary Endpoint (12-month)
Sponsor
Alleviant Medical, Inc. · industry
Contacts & investigators
ContactJennifer Olson · contact · jen.olson@alleviantmedical.com · +1 612 327 2741
InvestigatorJames Udelson, MD · principal_investigator, Tufts Medical Center
All locations (93)
Arizona Cardiovascular Research CenterActive Not Recruiting
Phoenix, Arizona, United States
HonorHealthTerminated
Scottsdale, Arizona, United States
Pima Heart and VascularRecruiting
Tucson, Arizona, United States
Memorial Care Long Beach Medical CenterRecruiting
Long Beach, 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
Santa Barbara Cottage HospitalRecruiting
Santa Barbara, California, United States
Hartford HospitalTerminated
Hartford, Connecticut, United States
The Cardiac and Vascular Institute (TCAVI)Recruiting
Gainesville, Florida, United States
HCA Florida Memorial HospitalRecruiting
Jacksonville, Florida, United States
NCH Research InstituteRecruiting
Naples, Florida, United States
Advent Health OrlandoRecruiting
Orlando, Florida, United States
Ascension Sacred HeartRecruiting
Pensacola, Florida, United States
Atlanta VA Health Care SystemRecruiting
Decatur, Georgia, United States
Advocate Illinois Masonic Medical CenterTerminated
Chicago, Illinois, United States
Midwest Cardiovascular InstituteRecruiting
Naperville, Illinois, United States
Prairie Education and Research CooperativeActive Not Recruiting
Springfield, Illinois, United States
Indiana UniversityRecruiting
Indianapolis, Indiana, United States
St. Elizabeth HealthcareRecruiting
Edgewood, Kentucky, United States
Cardiovascular Institute of the SouthRecruiting
Houma, Louisiana, United States
University Medical Center New OrleansRecruiting
New Orleans, Louisiana, United States
Johns Hopkins Medical InstitutionRecruiting
Baltimore, Maryland, United States
Brigham and Women's HospitalRecruiting
Boston, Massachusetts, United States
Boston Medical CenterRecruiting
Boston, Massachusetts, United States
Steward St. Elizabeth's Medical CenterTerminated
Brighton, Massachusetts, United States
VA Ann ArborRecruiting
Ann Arbor, Michigan, United States
Ascension St. John HospitalTerminated
Detroit, Michigan, 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
VA NY Harbor Healthcare SystemTerminated
New York, New York, United States
New York UniversityRecruiting
New York, New York, United States
Lenox Hill HospitalActive Not Recruiting
New York, New York, United States
St. Francis HospitalTerminated
Roslyn, New York, United States
Stony Brook MedicineRecruiting
Stony Brook, 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
South Oklahoma Heart Research, LLC.Recruiting
Oklahoma City, Oklahoma, United States
Providence St. Vincent's Medical CenterTerminated
Portland, Oregon, United States
Pinnacle Health Cardiovascular InstituteRecruiting
Harrisburg, Pennsylvania, United States
Medical University of South CarolinaRecruiting
Charleston, South Carolina, United States
Prisma Health - MidlandsRecruiting
Colombia, South Carolina, United States
Monument HealthRecruiting
Rapid City, South Dakota, United States
Stern Cardiovascular FoundationRecruiting
Germantown, Tennessee, United States
Tennova Healthcare - Turkey Creek Medical CenterRecruiting
Knoxville, Tennessee, United States
Hendrick HealthRecruiting
Abilene, Texas, United States
Austin HeartRecruiting
Austin, Texas, United States
UT SouthwesternRecruiting
Dallas, Texas, United States
Baylor Scott & White Research InstituteRecruiting
Plano, Texas, United States
Waco CardiologyRecruiting
Waco, Texas, United States
University of WashingtonActive Not Recruiting
Seattle, Washington, United States
Advocate Aurora Health/Aurora Research InstituteActive Not Recruiting
Milwaukee, Wisconsin, United States
Monash Health Victorian Heart HospitalRecruiting
Clayton, Victoria, Australia
Austin HospitalRecruiting
Heidelberg, Victoria, Australia
Medizinische Universität GrazRecruiting
Graz, Austria
OLV HospitalRecruiting
Aalst, Belgium
ZAS MiddelheimRecruiting
Antwerp, Belgium
AZ Sint Jan BruggeRecruiting
Bruges, Belgium
University Hospital UMHAT Sveti GeorgiRecruiting
Plovdiv, Bulgaria
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
Kardiocentrum Nemocnice AGEL Trinec-PodlesiRecruiting
Třinec, Czechia
Tbilisi Heart and VascularRecruiting
Tbilisi, Georgia
MarienkrankenhausTerminated
Hamburg, Germany
Universitatsklinikum Schleswig-Holstein (UKSH)Recruiting
Lübeck, Germany
Universitätsklinikum KardiologieRecruiting
Magdeburg, Germany
Shaare Zedek Medical CenterTerminated
Jerusalem, Israel
Tel Aviv Sourasky Medical CenterRecruiting
Tel Aviv, Israel
Shamir Medical CenterRecruiting
Zrifin, Israel
Humanitas Research MilanTerminated
Rozzano, Michigan, Italy
Instituto Auxologico ItalianoRecruiting
Milan, Italy
ChristChurch HospitalRecruiting
Christchurch, New Zealand
Dunedin HospitalRecruiting
Dunedin, New Zealand
University Clinical Hospital in OpoleRecruiting
Opole, Poland
Poznan University of Medical SciencesRecruiting
Poznan, Poland
Kashubian Center for Heart and Vascular Diseases, PomeranianRecruiting
Wejherowo, Poland
4th Military HospitalRecruiting
Wroclaw, Poland
Uniwesytecki Szpital KlinicznyRecruiting
Wroclaw, Poland
Silesian Center for Heart DiseaseRecruiting
Zabrze, Poland
Hospital de la Santa Creu i Sant PauRecruiting
Barcelona, Spain
Barcelona Hospital del MarRecruiting
Barcelona, Spain
Hospital Clinic de BarcelonaRecruiting
Barcelona, Spain
Germans Trias i Pujol University HospitalTerminated
Barcelona, Spain
Vall d'Hebron University Hospital BarcelonaRecruiting
Barcelona, Spain
Hospital Universitario Puerta del CadízTerminated
Cadiz, Spain
Hospital Universitario Puerta de HierroRecruiting
Madrid, Spain
Hospital Clínico Universitario de SalamancaRecruiting
Salamanca, Spain
Valencia Hospital ClinicoRecruiting
Valencia, Spain