RecruitingNot ApplicableNCT06812533

Alleviant ALLAY-HFrEF Study

Safety and Efficacy of the Alleviant No-Implant Interatrial Shunt in Patients With Heart Failure and Reduced Ejection Fraction

Sponsor

Alleviant Medical, Inc.

Enrollment

350 participants

Start Date

Mar 10, 2025

Study Type

INTERVENTIONAL

Conditions

Heart Failure

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Alleviant ALV1 System and Sham-Control for people with heart failure. The study is currently recruiting participants at 67 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAlleviant ALV1 System

Creation of interatrial shunt

OTHERSham-Control

Cardiac imaging

Locations(68)

Keck Medical Center of USC

Los Angeles, California, United States

University California Los Angeles Medical Center

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

Delray Medical Center

Delray Beach, Florida, United States

Ascension Sacred Heart

Pensacola, Florida, United States

Tampa General Hospital

Tampa, 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

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, United States

Washington University - St Louis

St Louis, Missouri, United States

UMC of Southern Nevada

Las Vegas, Nevada, United States

Deborah Heart & Lung Center

Browns Mills, New Jersey, United States

Englewood Medical Center

Englewood, New Jersey, United States

Stony Brook Medicine

New York, New York, United States

Rochester General Hospital

Rochester, New York, United States

University of Rochester Medical Center

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

Roper St. Francis Healthcare

Charleston, South Carolina, 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

Baylor Scott & White Research Institute

Plano, Texas, United States

Baylor Scott & White - Temple

Temple, Texas, United States

Waco Cardiology

Waco, Texas, United States

Carilion Clinic

Roanoke, Virginia, United States

Monash Health Victorian Heart Hospital

Clayton, Victoria, Australia

Alfred Hospital

Melbourne, Victoria, Australia

OLV Hospital

Aalst, Belgium

ZAS Middelheim

Antwerp, 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

Hippocration General Hospital Athens

Athens, Greece

Hygeia Hospital

Athens, Greece

European Interbalken Medical Center

Thessaloniki, Greece

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Shamir Medical Center

Zrifin, Israel

ChristChurch Hospital

Christchurch, New Zealand

Dunedin Hospital

Dunedin, New Zealand

University Clinical Hospital in Opole

Opole, Poland

Narodowy Instytut Kardiologii im. Stefana kardynała Wyszyńsk

Warsaw, Poland

Uniwesytecki Szpital Kliniczny

Wroclaw, Poland

Hospital Universitario A Coruna

A Coruña, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Hospital Clinic de Barcelona

Barcelona, Spain

Vall d'Hebron University Hospital Barcelona

Barcelona, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario Puerta de Hierro

Madrid, Spain

Hospital Clínico Universitario de Salamanca

Salamanca, Spain

Valencia Hospital Clinico

Valencia, Spain

View Full Details on ClinicalTrials.gov

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NCT06812533

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Alleviant ALLAY-HFrEF Study

Conditions

Summary

Eligibility

Plain Language Summary

Interventions

Locations(68)

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