Heart failure patients get a tiny shunt without a permanent implant

NCT ID NCT05685303

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

First seen Jun 24, 2026 · Last updated Aug 14, 2026 · Updated 2 times

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

diastolic heart failure heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HEART FAILURE

Contacts and locations

Locations

4th Military Hospital
RECRUITING

Wroclaw, Poland
AZ Sint Jan Brugge
RECRUITING

Bruges, Belgium
Advent Health Orlando
RECRUITING

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

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

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

Phoenix, Arizona, 85016, United States
Ascension Sacred Heart
RECRUITING

Pensacola, Florida, 32504, United States
Ascension St. John Hospital
TERMINATED

Detroit, Michigan, 48236, United States
Atlanta VA Health Care System
RECRUITING

Decatur, Georgia, 30032, United States
Austin Heart
RECRUITING

Austin, Texas, 78756, United States
Austin Hospital
RECRUITING

Heidelberg, Victoria, 3084, Australia
Barcelona Hospital del Mar
RECRUITING

Barcelona, 08033, Spain
Baylor Scott & White Research Institute
RECRUITING

Plano, Texas, 75093, United States
Boston Medical Center
RECRUITING

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

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

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)
RECRUITING

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

Montreal, Quebec, H2X 0C1, Canada
ChristChurch Hospital
RECRUITING

Christchurch, 8011, New Zealand
Cleveland Clinic
RECRUITING

Cleveland, Ohio, 44195, United States
Duke University Hospital
RECRUITING

Durham, North Carolina, 27705, United States
Dunedin Hospital
RECRUITING

Dunedin, 9016, New Zealand
Germans Trias i Pujol University Hospital
TERMINATED

Barcelona, 08916, Spain
HCA Florida Memorial Hospital
RECRUITING

Jacksonville, Florida, 32216, United States
Hartford Hospital
TERMINATED

Hartford, Connecticut, 06106, United States
Hendrick Health
RECRUITING

Abilene, Texas, 79601, United States
HonorHealth
TERMINATED

Scottsdale, Arizona, 85258, United States
Hospital Clinic de Barcelona
RECRUITING

Barcelona, 08036, Spain
Hospital Clínico Universitario de Salamanca
RECRUITING

Salamanca, Spain
Hospital Universitario Puerta de Hierro
RECRUITING

Madrid, 28222, Spain
Hospital Universitario Puerta del Cadíz
TERMINATED

Cadiz, 11009, Spain
Hospital de la Santa Creu i Sant Pau
RECRUITING

Barcelona, 08025, Spain
Humanitas Research Milan
TERMINATED

Rozzano, Michigan, Italy
Indiana University
RECRUITING

Indianapolis, Indiana, 46202, United States
Instituto Auxologico Italiano
RECRUITING

Milan, 20149, Italy
Johns Hopkins Medical Institution
RECRUITING

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

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

Wejherowo, 84-200, Poland
Lenox Hill Hospital
ACTIVE_NOT_RECRUITING

New York, New York, 10075, United States
Marienkrankenhaus
TERMINATED

Hamburg, 22087, Germany
Medical University of South Carolina
RECRUITING

Charleston, South Carolina, 29425, United States
Medizinische Universität Graz
RECRUITING

Graz, Austria
Memorial Care Long Beach Medical Center
RECRUITING

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

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

Minneapolis, Minnesota, 55407, United States
Mission Hospital
RECRUITING

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

Clayton, Victoria, 3068, Australia
Monument Health
RECRUITING

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

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

Naples, Florida, 34102, United States
New York University
RECRUITING

New York, New York, 10016, United States
OLV Hospital
RECRUITING

Aalst, Belgium
Pima Heart and Vascular
RECRUITING

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

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

Poznan, Poland
Prairie Education and Research Cooperative
ACTIVE_NOT_RECRUITING

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

Colombia, South Carolina, 29203, United States
ProMedica Toledo Hospital
RECRUITING

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

Portland, Oregon, 97225, United States
Santa Barbara Cottage Hospital
RECRUITING

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

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

Jerusalem, Israel
Shamir Medical Center
RECRUITING

Zrifin, Israel
Silesian Center for Heart Disease
RECRUITING

Zabrze, Poland
South Oklahoma Heart Research, LLC.
RECRUITING

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

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

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

Roslyn, New York, 11576, United States
Stern Cardiovascular Foundation
RECRUITING

Germantown, Tennessee, 38138, United States
Steward St. Elizabeth's Medical Center
TERMINATED

Brighton, Massachusetts, 02135, United States
Stony Brook Medicine
RECRUITING

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

Tbilisi, Georgia
Tel Aviv Sourasky Medical Center
RECRUITING

Tel Aviv, Israel
Tennova Healthcare - Turkey Creek Medical Center
RECRUITING

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

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

Sacramento, California, 95817, United States
UMC of Southern Nevada
RECRUITING

Las Vegas, Nevada, 89102, United States
UT Southwestern
RECRUITING

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

Lübeck, 23538, Germany
University Clinical Hospital in Opole
RECRUITING

Opole, Poland
University Hospital UMHAT Sveti Georgi
RECRUITING

Plovdiv, 4002, Bulgaria
University Medical Center New Orleans
RECRUITING

New Orleans, Louisiana, 70112, United States
University of California San Francisco
RECRUITING

San Francisco, California, 94143, United States
University of Washington
ACTIVE_NOT_RECRUITING

Seattle, Washington, 98195, United States
Universitätsklinikum Kardiologie
RECRUITING

Magdeburg, 39120, Germany
Uniwesytecki Szpital Kliniczny
RECRUITING

Wroclaw, Poland
VA Ann Arbor
RECRUITING

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

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

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

Barcelona, Spain
Waco Cardiology
RECRUITING

Waco, Texas, 76712, United States
Washington University - St Louis
RECRUITING

St Louis, Missouri, 63110, United States
ZAS Middelheim
RECRUITING

Antwerp, Belgium

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