Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

No-Implant shunt could ease heart failure burden

NCT ID NCT06812533

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 3 times

Summary

This study tests a new device that creates a small passage in the heart to relieve pressure, without leaving a permanent implant. It is for 350 people with heart failure and reduced pumping ability. The goal is to see if it reduces deaths, need for a heart pump or transplant, and heart failure events.

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

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 350 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * LVEF ≤ 40% * NYHA class II, III or ambulatory IV HF * Receiving optimal, maximally tolerated, stable GDMT Exclusion Criteria: * Advanced heart failure * Life-expectancy \< 12 months * Evidence of right heart dysfunction

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Heart failure are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

heart failure systolic heart failure

As listed by the trial registrant

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

Heart failure

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    66 sites in 10 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AZ Sint Jan Brugge

    RECRUITING

    Bruges, Belgium

  • Alfred Hospital

    RECRUITING

    Melbourne, Victoria, 3004, Australia

  • Ascension Sacred Heart

    RECRUITING

    Pensacola, Florida, 32504, United States

  • Atlanta VA Health Care System

    RECRUITING

    Decatur, Georgia, 30032, United States

  • Austin Heart

    RECRUITING

    Austin, Texas, 78756, United States

  • Baylor Scott & White - Temple

    RECRUITING

    Temple, Texas, 76508, United States

  • 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

  • Carilion Clinic

    RECRUITING

    Roanoke, Virginia, 24014, 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

  • Deborah Heart & Lung Center

    RECRUITING

    Browns Mills, New Jersey, 08015, United States

  • Delray Medical Center

    RECRUITING

    Delray Beach, Florida, 33484, United States

  • Duke University Hospital

    RECRUITING

    Durham, North Carolina, 27705, United States

  • Dunedin Hospital

    RECRUITING

    Dunedin, 9016, New Zealand

  • Englewood Medical Center

    RECRUITING

    Englewood, New Jersey, 07631, United States

  • European Interbalken Medical Center

    RECRUITING

    Thessaloniki, Greece

  • Hendrick Health

    RECRUITING

    Abilene, Texas, 79601, United States

  • Hippocration General Hospital Athens

    RECRUITING

    Athens, 11527, Greece

  • Hospital Clinic de Barcelona

    RECRUITING

    Barcelona, 08036, Spain

  • Hospital Clínico Universitario de Salamanca

    RECRUITING

    Salamanca, Spain

  • Hospital Universitario 12 de Octubre

    TERMINATED

    Madrid, 28041, Spain

  • Hospital Universitario A Coruna

    RECRUITING

    A Coruña, Spain

  • Hospital Universitario Puerta de Hierro

    RECRUITING

    Madrid, 28222, Spain

  • Hospital de la Santa Creu i Sant Pau

    RECRUITING

    Barcelona, 08025, Spain

  • Hygeia Hospital

    RECRUITING

    Athens, 15123, Greece

  • IUCPQ - Université Laval (Quebec)

    RECRUITING

    Québec, G1V 4G5, Canada

  • Keck Medical Center of USC

    RECRUITING

    Los Angeles, California, 90033, United States

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, 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

  • Narodowy Instytut Kardiologii im. Stefana kardynała Wyszyńsk

    RECRUITING

    Warsaw, Poland

  • OLV Hospital

    RECRUITING

    Aalst, Belgium

  • Pinnacle Health Cardiovascular Institute

    RECRUITING

    Harrisburg, Pennsylvania, 17101, United States

  • ProMedica Toledo Hospital

    RECRUITING

    Toledo, Ohio, 43606, United States

  • Rochester General Hospital

    RECRUITING

    Rochester, New York, 14621, United States

  • Roper St. Francis Healthcare

    RECRUITING

    Charleston, South Carolina, 29414, United States

  • Scripps Clinical Research Services

    RECRUITING

    San Diego, California, 92121, United States

  • Shamir Medical Center

    RECRUITING

    Zrifin, Israel

  • Southlake Regional Hospital Centre

    RECRUITING

    Newmarket, Ontario, L3Y 2P6, Canada

  • Stony Brook Medicine

    RECRUITING

    New York, New York, 11794, United States

  • Tampa General Hospital

    RECRUITING

    Tampa, Florida, 33606, 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

  • Texas Cardiac Arrhythmia Research Foundation

    TERMINATED

    Austin, Texas, 78705, United States

  • Tufts Medical Center

    RECRUITING

    Boston, Massachusetts, 02111, United States

  • UC Davis Medical Center

    RECRUITING

    Sacramento, California, 95817, United States

  • UMC of Southern Nevada

    RECRUITING

    Las Vegas, Nevada, 89102, United States

  • University California Los Angeles Medical Center

    RECRUITING

    Los Angeles, California, 90095, United States

  • University Clinical Hospital in Opole

    RECRUITING

    Opole, Poland

  • 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 Rochester Medical Center

    NOT_YET_RECRUITING

    Rochester, New York, 14642, United States

  • Uniwesytecki Szpital Kliniczny

    RECRUITING

    Wroclaw, Poland

  • 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

More trials for these conditions

Other studies related to the condition(s) this trial covers.