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ENROLLING BY INVITATION
NCT05685303
NA

Alleviant ALLAY-HF Study

Sponsor: Alleviant Medical, Inc.

View on ClinicalTrials.gov

Summary

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.

Official title: Safety and Efficacy of the Alleviant System for No-Implant Interatrial Shunt Creation in Patients With Chronic Heart Failure

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

500

Start Date

2023-01-10

Completion Date

2032-07-31

Last Updated

2025-10-23

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Alleviant ALV1 System

Creation of interatrial shunt

OTHER

Sham-Control

Cardiac imaging

Locations (90)

University of Alabama

Birmingham, Alabama, United States

Arizona Cardiovascular Research Center

Phoenix, Arizona, United States

Pima Heart and Vascular

Tucson, Arizona, United States

Memorial Care Long Beach Medical Center

Long Beach, California, United States

UC Davis Medical Center

Sacramento, California, United States

Scripps Clinical Research Services

San Diego, California, United States

San Francisco VA

San Francisco, California, United States

University of California San Francisco

San Francisco, California, United States

Santa Barbara Cottage Hospital

Santa Barbara, California, United States

Hartford Hospital

Hartford, Connecticut, United States

The Cardiac and Vascular Institute (TCAVI)

Gainesville, Florida, United States

HCA Florida Memorial Hospital

Jacksonville, Florida, United States

NCH Research Institute

Naples, Florida, United States

Advent Health Orlando

Orlando, Florida, United States

Ascension Sacred Heart

Pensacola, Florida, United States

Atlanta VA Health Care System

Decatur, Georgia, United States

Advocate Illinois Masonic Medical Center

Chicago, Illinois, United States

Midwest Cardiovascular Institute

Naperville, Illinois, United States

Prairie Education and Research Cooperative

Springfield, Illinois, United States

Indiana University

Indianapolis, Indiana, United States

St. Elizabeth Healthcare

Edgewood, Kentucky, United States

Cardiovascular Institute of the South

Houma, Louisiana, United States

University Medical Center New Orleans

New Orleans, Louisiana, United States

Johns Hopkins Medical Institution

Baltimore, Maryland, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Boston Medical Center

Boston, Massachusetts, United States

VA Ann Arbor

Ann Arbor, Michigan, United States

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, United States

Washington University - St Louis

St Louis, Missouri, United States

VA NY Harbor Healthcare System

New York, New York, United States

New York University

New York, New York, United States

Lenox Hill Hospital

New York, New York, United States

St. Francis Hospital

Roslyn, New York, United States

Stony Brook Medicine

Stony Brook, 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

South Oklahoma Heart Research, LLC.

Oklahoma City, Oklahoma, United States

Providence St. Vincent's Medical Center

Portland, Oregon, United States

Pinnacle Health Cardiovascular Institute

Harrisburg, Pennsylvania, United States

Prisma Health - Midlands

Columbia, South Carolina, United States

Monument Health

Rapid City, South Dakota, United States

Stern Cardiovascular Foundation

Germantown, Tennessee, United States

Tennova Healthcare - Turkey Creek Medical Center

Knoxville, Tennessee, United States

Hendrick Health

Abilene, Texas, United States

Austin Heart

Austin, Texas, United States

UT Southwestern

Dallas, Texas, United States

Baylor Scott & White Research Institute

Plano, Texas, United States

NextStage Clinical Research

Waco, Texas, United States

University of Washington

Seattle, Washington, United States

Advocate Aurora Health/Aurora Research Institute

Milwaukee, Wisconsin, United States

Monash Health Victorian Heart Hospital

Clayton, Victoria, Australia

Royal Adelaide Hospital

Adelaide, Australia

Medizinische Universität Graz

Graz, Austria

OLV Hospital

Aalst, Belgium

ZNA 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

Tbilisi Heart and Vascular

Tbilisi, Georgia

Heart and Vascular Center-Bad Bevensen

Bad Bevensen, Germany

Herz- und Gefasszentrum Bad Bevensen

Bad Bevensen, Germany

University of Gießen

Giessen, Germany

Marienkrankenhaus

Hamburg, Germany

Askelepios Klinik Altona

Hamburg, Germany

St. Vincentius Kliniken

Karlsruhe, Germany

Universitatsklinikum Schleswig-Holstein (UKSH)

Lübeck, Germany

Universitätsklinikum Kardiologie

Magdeburg, Germany

Universitatsmedizin Rostock

Rostock, Germany

European Interbalken Medical Center

Thessaloniki, Greece

Shaare Zedek Medical Center

Jerusalem, Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Shamir Medical Center

Zrifin, Israel

Humanitas Research Milan

Rozzano, MI, Italy

Instituto Auxologico Italiano

Milan, Italy

ChristChurch Hospital

Christchurch, New Zealand

Dunedin Hospital

Dunedin, New Zealand

Poznan University of Medical Sciences

Poznan, Poland

4th Military Hospital

Wroclaw, Poland

Uniwesytecki Szpital Kliniczny

Wroclaw, Poland

Silesian Center for Heart Disease

Zabrze, Poland

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Barcelona Hospital del Mar

Barcelona, Spain

Hospital Clinic de Barcelona

Barcelona, Spain

Hospital Universitario Puerta de Hierro

Madrid, Spain

Hospital Clínico Universitario de Salamanca

Salamanca, Spain

Valencia Hospital Clinico

Valencia, Spain