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Alleviant ALLAY-HFrEF Study
Sponsor: Alleviant Medical, Inc.
Summary
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.
Official title: Safety and Efficacy of the Alleviant No-Implant Interatrial Shunt in Patients With Heart Failure and Reduced Ejection Fraction
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
350
Start Date
2025-03-10
Completion Date
2028-12
Last Updated
2025-12-16
Healthy Volunteers
No
Conditions
Interventions
Alleviant ALV1 System
Creation of interatrial shunt
Sham-Control
Cardiac imaging
Locations (43)
Keck Medical Center of USC
Los Angeles, California, United States
UC Davis Medical Center
Sacramento, California, United States
Scripps Clinical Research Services
San Diego, California, United States
University of California San Francisco
San Francisco, California, United States
Ascension Sacred Heart
Pensacola, Florida, United States
Atlanta VA Health Care System
Decatur, Georgia, United States
Midwest Cardiovascular Institute
Naperville, Illinois, United States
Cardiovascular Institute of the South
Houma, Louisiana, United States
University Medical Center New Orleans
New Orleans, Louisiana, United States
Tufts Medical Center
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Boston Medical Center
Boston, Massachusetts, United States
Washington University - St Louis
St Louis, Missouri, United States
Stony Brook Medicine
New York, New York, United States
Rochester General Hospital
Rochester, New York, United States
Mission Hospital
Asheville, North Carolina, United States
Duke University Hospital
Durham, North Carolina, United States
NC Heart and Vascular Research
Raleigh, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
ProMedica Toledo Hospital
Toledo, Ohio, United States
Pinnacle Health Cardiovascular Institute
Harrisburg, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Monument Health
Rapid City, South Dakota, United States
Tennova Healthcare - Turkey Creek Medical Center
Knoxville, Tennessee, United States
Hendrick Health
Abilene, Texas, United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States
Austin Heart
Austin, Texas, United States
NextStage Clinical Research
Waco, Texas, United States
Carilion Clinic
Roanoke, Virginia, United States
OLV Hospital
Aalst, Belgium
AZ Sint Jan Brugge
Bruges, Belgium
Southlake Regional Hospital Centre
Newmarket, Ontario, Canada
Centre hospitalier de l'Universite de Montreal (CHUM)
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)
Montreal, Quebec, Canada
IUCPQ - Université Laval (Quebec)
Québec, Canada
Tbilisi Heart and Vascular
Tbilisi, Georgia
Uniwesytecki Szpital Kliniczny
Wroclaw, Poland
Hospital Universitario A Coruna
A Coruña, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Vall d'Hebron University Hospital Barcelona
Barcelona, Spain
Hospital Universitario Puerta de Hierro
Madrid, Spain
Hospital Clínico Universitario de Salamanca
Salamanca, Spain
Valencia Hospital Clinico
Valencia, Spain