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ENROLLING BY INVITATION
NCT06812533
NA

Alleviant ALLAY-HFrEF Study

Sponsor: Alleviant Medical, Inc.

View on ClinicalTrials.gov

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

DEVICE

Alleviant ALV1 System

Creation of interatrial shunt

OTHER

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