Heart failure patients get a tiny shunt without a permanent implant
NCT ID NCT05685303
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a device that creates a small opening between the heart's upper chambers to relieve pressure in people with chronic heart failure. Unlike other shunts, this one leaves no permanent implant behind. The trial will compare the device to a sham procedure in 700 patients and measure effects on survival, heart failure events, and quality of life after one year.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
Active substance
Alleviant ALV1 System (a device that creates a small passage between the upper chambers of the heart without leaving a permanent implant)
What this could lead to
If it works, this could offer a new, less invasive way to lower pressure in the heart and reduce symptoms for people with a certain type of heart failure.
What could go wrong
This is an early-stage study with no prior proof of benefit in humans. The sham control means some patients may not improve, and there are risks from the catheter procedure itself.
Disclaimer
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This is a summary of
the original study
.
Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
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Locations
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4th Military Hospital
Wroclaw, Poland
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AZ Sint Jan Brugge
Bruges, Belgium
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Acibadem City Clinic Cardiovascular Center Sofia
Sofia, 1700, Bulgaria
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Acibadem City Clinic University Tokuda Hospital
Sofia, 1407, Bulgaria
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Advent Health Orlando
Orlando, Florida, 32803, United States
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Advocate Aurora Health/Aurora Research Institute
Milwaukee, Wisconsin, 53215, United States
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Advocate Illinois Masonic Medical Center
Chicago, Illinois, 60657, United States
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Arizona Cardiovascular Research Center
Phoenix, Arizona, 85016, United States
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Ascension Sacred Heart
Pensacola, Florida, 32504, United States
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Askelepios Klinik Altona
Hamburg, 22763, Germany
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Atlanta VA Health Care System
Decatur, Georgia, 30032, United States
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Austin Heart
Austin, Texas, 78756, United States
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Austin Hospital
Heidelberg, Victoria, 3084, Australia
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Barcelona Hospital del Mar
Barcelona, 08033, Spain
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Baylor Scott & White Research Institute
Plano, Texas, 75093, United States
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Boston Medical Center
Boston, Massachusetts, 02118, United States
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Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
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Cardiovascular Institute of the South
Houma, Louisiana, 70360, United States
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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
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Centre hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, H2X 0C1, Canada
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ChristChurch Hospital
Christchurch, 8011, New Zealand
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Cleveland Clinic
Cleveland, Ohio, 44195, United States
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Duke University Hospital
Durham, North Carolina, 27705, United States
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Dunedin Hospital
Dunedin, 9016, New Zealand
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European Interbalken Medical Center
Thessaloniki, Greece
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HCA Florida Memorial Hospital
Jacksonville, Florida, 32216, United States
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Hartford Hospital
Hartford, Connecticut, 06106, United States
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Heart and Vascular Center-Bad Bevensen
Bad Bevensen, 29549, Germany
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Hendrick Health
Abilene, Texas, 79601, United States
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Herz- und Gefasszentrum Bad Bevensen
Bad Bevensen, 29549, Germany
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Hospital Clinic de Barcelona
Barcelona, 08036, Spain
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Hospital Clínico Universitario de Salamanca
Salamanca, Spain
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Hospital Universitario Puerta de Hierro
Madrid, 28222, Spain
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Hospital de la Santa Creu i Sant Pau
Barcelona, 08025, Spain
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Humanitas Research Milan
Rozzano, MI, Italy
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Indiana University
Indianapolis, Indiana, 46202, United States
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Instituto Auxologico Italiano
Milan, 20149, Italy
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Johns Hopkins Medical Institution
Baltimore, Maryland, 21287, United States
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Kardiocentrum Nemocnice AGEL Trinec-Podlesi
Třinec, 73961, Czechia
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Kashubian Center for Heart and Vascular Diseases, Pomeranian
Wejherowo, 84-200, Poland
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Lenox Hill Hospital
New York, New York, 10075, United States
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Marienkrankenhaus
Hamburg, 22087, Germany
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Medizinische Universität Graz
Graz, Austria
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Memorial Care Long Beach Medical Center
Long Beach, California, 90806, United States
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Midwest Cardiovascular Institute
Naperville, Illinois, 60540, United States
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Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407, United States
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Mission Hospital
Asheville, North Carolina, 28801, United States
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Monash Health Victorian Heart Hospital
Clayton, Victoria, 3068, Australia
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Monument Health
Rapid City, South Dakota, 57701, United States
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NC Heart and Vascular Research
Raleigh, North Carolina, 27607, United States
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NCH Research Institute
Naples, Florida, 34102, United States
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New York University
New York, New York, 10016, United States
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NextStage Clinical Research
Waco, Texas, 76712, United States
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OLV Hospital
Aalst, Belgium
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Pima Heart and Vascular
Tucson, Arizona, 85718, United States
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Pinnacle Health Cardiovascular Institute
Harrisburg, Pennsylvania, 17101, United States
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Poznan University of Medical Sciences
Poznan, Poland
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Prairie Education and Research Cooperative
Springfield, Illinois, 62769, United States
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Prisma Health - Midlands
Columbia, South Carolina, 29203, United States
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ProMedica Toledo Hospital
Toledo, Ohio, 43606, United States
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Providence St. Vincent's Medical Center
Portland, Oregon, 97225, United States
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San Francisco VA
San Francisco, California, 94121, United States
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Santa Barbara Cottage Hospital
Santa Barbara, California, 93105, United States
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Scripps Clinical Research Services
San Diego, California, 92121, United States
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Shaare Zedek Medical Center
Jerusalem, Israel
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Shamir Medical Center
Zrifin, Israel
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Silesian Center for Heart Disease
Zabrze, Poland
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South Oklahoma Heart Research, LLC.
Oklahoma City, Oklahoma, 73135, United States
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Southlake Regional Hospital Centre
Newmarket, Ontario, L3Y 2P6, Canada
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St. Elizabeth Healthcare
Edgewood, Kentucky, 41017, United States
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St. Francis Hospital
Roslyn, New York, 11576, United States
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St. Vincentius Kliniken
Karlsruhe, 76137, Germany
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Stern Cardiovascular Foundation
Germantown, Tennessee, 38138, United States
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Stony Brook Medicine
Stony Brook, New York, 11794-8167, United States
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Tbilisi Heart and Vascular
Tbilisi, Georgia
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Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
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Tennova Healthcare - Turkey Creek Medical Center
Knoxville, Tennessee, 37934, United States
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The Cardiac and Vascular Institute (TCAVI)
Gainesville, Florida, 32504, United States
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UC Davis Medical Center
Sacramento, California, 95817, United States
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UT Southwestern
Dallas, Texas, 75930, United States
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Universitatsklinikum Schleswig-Holstein (UKSH)
Lübeck, 23538, Germany
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Universitatsmedizin Rostock
Rostock, 18057, Germany
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University Clinical Hospital in Opole
Opole, Poland
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University Hospital UMHAT Sveti Georgi
Plovdiv, 4002, Bulgaria
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University Medical Center New Orleans
New Orleans, Louisiana, 70112, United States
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University of Alabama
Birmingham, Alabama, 35249, United States
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University of California San Francisco
San Francisco, California, 94143, United States
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University of Gießen
Giessen, 35392, Germany
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University of Washington
Seattle, Washington, 98195, United States
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Universitätsklinikum Kardiologie
Magdeburg, 39120, Germany
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Uniwesytecki Szpital Kliniczny
Wroclaw, Poland
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VA Ann Arbor
Ann Arbor, Michigan, 48105, United States
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VA NY Harbor Healthcare System
New York, New York, 10010, United States
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Valencia Hospital Clinico
Valencia, 46010, Spain
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Vall d'Hebron University Hospital Barcelona
Barcelona, Spain
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Washington University - St Louis
St Louis, Missouri, 63110, United States
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ZAS Middelheim
Antwerp, Belgium