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Heart failure patients get a tiny shunt without a permanent implant

NCT ID NCT05685303

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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.

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 700 people

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

Started

Jan 2023

Expected to finish

Dec 2032

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

40 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: 1. Symptomatic HFpEF/HFmrEF with LVEF greater than or equal to 40% 2. NYHA Class II, III or ambulatory IV 3. Exercise right heart catheterization\* 1. Elevated left atrial pressure during exercise right heart catheterization (greater than or equal to 25 mmHg) 2. Exercise PVR \< 1.8 WU 4. Ongoing stable GDMT Exclusion Criteria: 1. Advanced heart failure 2. Presence of a pacemaker 3. Evidence of right heart dysfunction

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Get notified about this study

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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

How to take part

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

  1. The places running it

    75 sites in 14 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

  • 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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