No-Implant heart shunt could ease burden of chronic heart failure

NCT ID NCT05685303

ENROLLING_BY_INVITATION Disease control Sponsor: Alleviant Medical, Inc. Source: ClinicalTrials.gov ↗

First seen Nov 01, 2025 · Last updated May 13, 2026 · Updated 28 times

Summary

This study tests a new device that creates a small passage between the upper chambers of the heart to help relieve pressure in people with chronic heart failure. The device is inserted through a blood vessel and does not leave a permanent implant. About 700 participants with heart failure and preserved heart pumping function will be randomly assigned to receive the procedure or a sham procedure. The goal is to see if this approach improves survival, reduces heart failure events, and enhances quality of life over 12 months.

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Contacts and locations

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Locations

4th Military Hospital

Wroclaw, Poland
AZ Sint Jan Brugge

Bruges, Belgium
Acibadem City Clinic Cardiovascular Center Sofia

Sofia, 1700, Bulgaria
Acibadem City Clinic University Tokuda Hospital

Sofia, 1407, Bulgaria
Advent Health Orlando

Orlando, Florida, 32803, United States
Advocate Aurora Health/Aurora Research Institute

Milwaukee, Wisconsin, 53215, United States
Advocate Illinois Masonic Medical Center

Chicago, Illinois, 60657, United States
Arizona Cardiovascular Research Center

Phoenix, Arizona, 85016, United States
Ascension Sacred Heart

Pensacola, Florida, 32504, United States
Askelepios Klinik Altona

Hamburg, 22763, Germany
Atlanta VA Health Care System

Decatur, Georgia, 30032, United States
Austin Heart

Austin, Texas, 78756, United States
Austin Hospital

Heidelberg, Victoria, 3084, Australia
Barcelona Hospital del Mar

Barcelona, 08033, Spain
Baylor Scott & White Research Institute

Plano, Texas, 75093, United States
Boston Medical Center

Boston, Massachusetts, 02118, United States
Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States
Cardiovascular Institute of the South

Houma, Louisiana, 70360, United States
Centre Integre Universitaire de Sainte et de Services Scoiiaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CIUSSS de l'Estrie - CHUS)

Montreal, Quebec, H2X 0C1, Canada
Centre hospitalier de l'Universite de Montreal (CHUM)

Montreal, Quebec, H2X 0C1, Canada
ChristChurch Hospital

Christchurch, 8011, New Zealand
Cleveland Clinic

Cleveland, Ohio, 44195, United States
Duke University Hospital

Durham, North Carolina, 27705, United States
Dunedin Hospital

Dunedin, 9016, New Zealand
European Interbalken Medical Center

Thessaloniki, Greece
HCA Florida Memorial Hospital

Jacksonville, Florida, 32216, United States
Hartford Hospital

Hartford, Connecticut, 06106, United States
Heart and Vascular Center-Bad Bevensen

Bad Bevensen, 29549, Germany
Hendrick Health

Abilene, Texas, 79601, United States
Herz- und Gefasszentrum Bad Bevensen

Bad Bevensen, 29549, Germany
Hospital Clinic de Barcelona

Barcelona, 08036, Spain
Hospital Clínico Universitario de Salamanca

Salamanca, Spain
Hospital Universitario Puerta de Hierro

Madrid, 28222, Spain
Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain
Humanitas Research Milan

Rozzano, MI, Italy
Indiana University

Indianapolis, Indiana, 46202, United States
Instituto Auxologico Italiano

Milan, 20149, Italy
Johns Hopkins Medical Institution

Baltimore, Maryland, 21287, United States
Kardiocentrum Nemocnice AGEL Trinec-Podlesi

Třinec, 73961, Czechia
Kashubian Center for Heart and Vascular Diseases, Pomeranian

Wejherowo, 84-200, Poland
Lenox Hill Hospital

New York, New York, 10075, United States
Marienkrankenhaus

Hamburg, 22087, Germany
Medizinische Universität Graz

Graz, Austria
Memorial Care Long Beach Medical Center

Long Beach, California, 90806, United States
Midwest Cardiovascular Institute

Naperville, Illinois, 60540, United States
Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States
Mission Hospital

Asheville, North Carolina, 28801, United States
Monash Health Victorian Heart Hospital

Clayton, Victoria, 3068, Australia
Monument Health

Rapid City, South Dakota, 57701, United States
NC Heart and Vascular Research

Raleigh, North Carolina, 27607, United States
NCH Research Institute

Naples, Florida, 34102, United States
New York University

New York, New York, 10016, United States
NextStage Clinical Research

Waco, Texas, 76712, United States
OLV Hospital

Aalst, Belgium
Pima Heart and Vascular

Tucson, Arizona, 85718, United States
Pinnacle Health Cardiovascular Institute

Harrisburg, Pennsylvania, 17101, United States
Poznan University of Medical Sciences

Poznan, Poland
Prairie Education and Research Cooperative

Springfield, Illinois, 62769, United States
Prisma Health - Midlands

Columbia, South Carolina, 29203, United States
ProMedica Toledo Hospital

Toledo, Ohio, 43606, United States
Providence St. Vincent's Medical Center

Portland, Oregon, 97225, United States
San Francisco VA

San Francisco, California, 94121, United States
Santa Barbara Cottage Hospital

Santa Barbara, California, 93105, United States
Scripps Clinical Research Services

San Diego, California, 92121, United States
Shaare Zedek Medical Center

Jerusalem, Israel
Shamir Medical Center

Zrifin, Israel
Silesian Center for Heart Disease

Zabrze, Poland
South Oklahoma Heart Research, LLC.

Oklahoma City, Oklahoma, 73135, United States
Southlake Regional Hospital Centre

Newmarket, Ontario, L3Y 2P6, Canada
St. Elizabeth Healthcare

Edgewood, Kentucky, 41017, United States
St. Francis Hospital

Roslyn, New York, 11576, United States
St. Vincentius Kliniken

Karlsruhe, 76137, Germany
Stern Cardiovascular Foundation

Germantown, Tennessee, 38138, United States
Stony Brook Medicine

Stony Brook, New York, 11794-8167, United States
Tbilisi Heart and Vascular

Tbilisi, Georgia
Tel Aviv Sourasky Medical Center

Tel Aviv, Israel
Tennova Healthcare - Turkey Creek Medical Center

Knoxville, Tennessee, 37934, United States
The Cardiac and Vascular Institute (TCAVI)

Gainesville, Florida, 32504, United States
UC Davis Medical Center

Sacramento, California, 95817, United States
UT Southwestern

Dallas, Texas, 75930, United States
Universitatsklinikum Schleswig-Holstein (UKSH)

Lübeck, 23538, Germany
Universitatsmedizin Rostock

Rostock, 18057, Germany
University Clinical Hospital in Opole

Opole, Poland
University Hospital UMHAT Sveti Georgi

Plovdiv, 4002, Bulgaria
University Medical Center New Orleans

New Orleans, Louisiana, 70112, United States
University of Alabama

Birmingham, Alabama, 35249, United States
University of California San Francisco

San Francisco, California, 94143, United States
University of Gießen

Giessen, 35392, Germany
University of Washington

Seattle, Washington, 98195, United States
Universitätsklinikum Kardiologie

Magdeburg, 39120, Germany
Uniwesytecki Szpital Kliniczny

Wroclaw, Poland
VA Ann Arbor

Ann Arbor, Michigan, 48105, United States
VA NY Harbor Healthcare System

New York, New York, 10010, United States
Valencia Hospital Clinico

Valencia, 46010, Spain
Vall d'Hebron University Hospital Barcelona

Barcelona, Spain
Washington University - St Louis

St Louis, Missouri, 63110, United States
ZAS Middelheim

Antwerp, Belgium

Conditions

Explore the condition pages connected to this study.

HEART FAILURE