Alleviant ALLAY-HF Study

Last updated: August 12, 2026
Sponsor: Alleviant Medical, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chest Pain

Congestive Heart Failure

Hyponatremia

Treatment

Alleviant ALV1 System

Sham-Control

Clinical Study ID

NCT05685303
CIP-0003
  • Ages > 40
  • All Genders

Study Summary

Prospective, multicenter, randomized, sham-controlled, double blinded, adaptive study designed to evaluate the safety and efficacy of a percutaneously created interatrial shunt using the Alleviant ALV1 System in patients with HFpEF/HFmrEF.

Eligibility Criteria

Inclusion

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*

  4. Elevated left atrial pressure during exercise right heart catheterization (greater than or equal to 25 mmHg)

  5. Exercise PVR < 1.8 WU

  6. Ongoing stable GDMT

Exclusion

Exclusion Criteria:

  1. Advanced heart failure

  2. Presence of a pacemaker

  3. Evidence of right heart dysfunction

Study Design

Total Participants: 700
Treatment Group(s): 2
Primary Treatment: Alleviant ALV1 System
Phase:
Study Start date:
January 10, 2023
Estimated Completion Date:
December 01, 2032

Connect with a study center

  • Monash Health Victorian Heart Hospital

    Clayton, Victoria 3068
    Australia

    Active - Recruiting

  • Austin Hospital

    Heidelberg, Victoria 3084
    Australia

    Active - Recruiting

  • Medizinische Universität Graz

    Graz,
    Austria

    Active - Recruiting

  • OLV Hospital

    Aalst,
    Belgium

    Active - Recruiting

  • ZAS Middelheim

    Antwerp,
    Belgium

    Active - Recruiting

  • AZ Sint Jan Brugge

    Bruges,
    Belgium

    Active - Recruiting

  • University Hospital UMHAT Sveti Georgi

    Plovdiv, 4002
    Bulgaria

    Active - Recruiting

  • Acibadem City Clinic University Tokuda Hospital

    Sofia, 1407
    Bulgaria

    Site Not Available

  • Southlake Regional Hospital Centre

    Newmarket, Ontario L3Y 2P6
    Canada

    Active - Recruiting

  • 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

    Active - Recruiting

  • Centre hospitalier de l'Universite de Montreal (CHUM)

    Montreal, Quebec H2X 0C1
    Canada

    Active - Recruiting

  • Centre hospitalier de l'Universite de Montreal (CHUM)

    Montréal, Quebec H2X 0C1
    Canada

    Site Not Available

  • Centre Integre Universitaire de Sainte et de Services Scoiiaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CIUSSS de l'Estrie - CHUS)

    Montreal 6077243, Quebec 6115047 H2X 0C1
    Canada

    Site Not Available

  • Kardiocentrum Nemocnice AGEL Trinec-Podlesi

    Třinec, 73961
    Czechia

    Active - Recruiting

  • Tbilisi Heart and Vascular

    Tbilisi,
    Georgia

    Active - Recruiting

  • Heart and Vascular Center-Bad Bevensen

    Bad Bevensen, 29549
    Germany

    Site Not Available

  • Heart and Vascular Center-Bad Bevensen

    Bad Bevensen 2949511, 29549
    Germany

    Site Not Available

  • Askelepios Klinik Altona

    Hamburg, 22763
    Germany

    Site Not Available

  • Marienkrankenhaus

    Hamburg, 22087
    Germany

    Terminated

  • Marienkrankenhaus

    Hamburg 2911298, 22087
    Germany

    Site Not Available

  • Universitatsklinikum Schleswig-Holstein (UKSH)

    Lübeck, 23538
    Germany

    Active - Recruiting

  • Universitätsklinikum Kardiologie

    Magdeburg, 39120
    Germany

    Active - Recruiting

  • Shaare Zedek Medical Center

    Jerusalem,
    Israel

    Terminated

  • Tel Aviv Sourasky Medical Center

    Tel Aviv,
    Israel

    Active - Recruiting

  • Shamir Medical Center

    Zrifin,
    Israel

    Active - Recruiting

  • Humanitas Research Milan

    Rozzano, Michigan
    Italy

    Terminated

  • Instituto Auxologico Italiano

    Milan, 20149
    Italy

    Active - Recruiting

  • ChristChurch Hospital

    Christchurch, 8011
    New Zealand

    Active - Recruiting

  • Dunedin Hospital

    Dunedin, 9016
    New Zealand

    Active - Recruiting

  • University Clinical Hospital in Opole

    Opole,
    Poland

    Active - Recruiting

  • Poznan University of Medical Sciences

    Poznan,
    Poland

    Active - Recruiting

  • Kashubian Center for Heart and Vascular Diseases, Pomeranian

    Wejherowo, 84-200
    Poland

    Active - Recruiting

  • 4th Military Hospital

    Wroclaw,
    Poland

    Active - Recruiting

  • Uniwesytecki Szpital Kliniczny

    Wroclaw,
    Poland

    Active - Recruiting

  • Uniwesytecki Szpital Kliniczny

    Wroclaw 3081368,
    Poland

    Site Not Available

  • Uniwesytecki Szpital Kliniczny

    Wrocław,
    Poland

    Site Not Available

  • Silesian Center for Heart Disease

    Zabrze,
    Poland

    Active - Recruiting

  • Barcelona Hospital del Mar

    Barcelona, 08033
    Spain

    Active - Recruiting

  • Germans Trias i Pujol

    Barcelona, 08916
    Spain

    Site Not Available

  • Germans Trias i Pujol University Hospital

    Barcelona, 08916
    Spain

    Terminated

  • Hospital Clinic de Barcelona

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025
    Spain

    Active - Recruiting

  • Vall d'Hebron University Hospital Barcelona

    Barcelona,
    Spain

    Active - Recruiting

  • Barcelona Hospital del Mar

    Barcelona 3128760, 08033
    Spain

    Site Not Available

  • Hospital de la Santa Creu i Sant Pau

    Barcelona 3128760, 08025
    Spain

    Site Not Available

  • Hospital Universitario Puerta del Cadíz

    Cadiz, 11009
    Spain

    Terminated

  • Hospital Universitario Puerta de Hierro

    Madrid, 28222
    Spain

    Active - Recruiting

  • Hospital Clínico Universitario de Salamanca

    Salamanca,
    Spain

    Active - Recruiting

  • Valencia Hospital Clinico

    Valencia, 46010
    Spain

    Active - Recruiting

  • Arizona Cardiovascular Research Center

    Phoenix, Arizona 85016
    United States

    Site Not Available

  • HonorHealth

    Scottsdale, Arizona 85258
    United States

    Terminated

  • Pima Heart and Vascular

    Tucson, Arizona 85718
    United States

    Active - Recruiting

  • Memorial Care Long Beach Medical Center

    Long Beach, California 90806
    United States

    Active - Recruiting

  • UC Davis Medical Center

    Sacramento, California 95817
    United States

    Active - Recruiting

  • Scripps Clinical Research Services

    San Diego, California 92121
    United States

    Active - Recruiting

  • San Francisco VA

    San Francisco, California 94121
    United States

    Site Not Available

  • University of California San Francisco

    San Francisco, California 94143
    United States

    Active - Recruiting

  • Santa Barbara Cottage Hospital

    Santa Barbara, California 93105
    United States

    Active - Recruiting

  • San Francisco VA

    San Francisco 5391959, California 5332921 94121
    United States

    Site Not Available

  • Hartford Hospital

    Hartford, Connecticut 06106
    United States

    Terminated

  • The Cardiac and Vascular Institute (TCAVI)

    Gainesville, Florida 32504
    United States

    Active - Recruiting

  • HCA Florida Memorial Hospital

    Jacksonville, Florida 32216
    United States

    Active - Recruiting

  • University of Florida Jacksonville

    Jacksonville, Florida 32206
    United States

    Site Not Available

  • NCH Research Institute

    Naples, Florida 34102
    United States

    Active - Recruiting

  • Advent Health Orlando

    Orlando, Florida 32803
    United States

    Active - Recruiting

  • Ascension Sacred Heart

    Pensacola, Florida 32504
    United States

    Active - Recruiting

  • Atlanta VA Health Care System

    Decatur, Georgia 30032
    United States

    Active - Recruiting

  • Advocate Illinois Masonic Medical Center

    Chicago, Illinois 60657
    United States

    Terminated

  • Midwest Cardiovascular Institute

    Naperville, Illinois 60540
    United States

    Active - Recruiting

  • Prairie Education and Research Cooperative

    Springfield, Illinois 62769
    United States

    Site Not Available

  • Indiana University

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • St. Elizabeth Healthcare

    Edgewood, Kentucky 41017
    United States

    Active - Recruiting

  • Cardiovascular Institute of the South

    Houma, Louisiana 70360
    United States

    Active - Recruiting

  • University Medical Center New Orleans

    New Orleans, Louisiana 70112
    United States

    Active - Recruiting

  • Johns Hopkins Medical Institution

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • Boston Medical Center

    Boston, Massachusetts 02118
    United States

    Active - Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Steward St. Elizabeth's Medical Center

    Brighton, Massachusetts 02135
    United States

    Terminated

  • Boston Medical Center

    Boston 4930956, Massachusetts 6254926 02118
    United States

    Site Not Available

  • VA Ann Arbor

    Ann Arbor, Michigan 48105
    United States

    Active - Recruiting

  • Ascension St. John Hospital

    Detroit, Michigan 48236
    United States

    Terminated

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota 55407
    United States

    Active - Recruiting

  • Washington University - St Louis

    St Louis, Missouri 63110
    United States

    Active - Recruiting

  • UMC of Southern Nevada

    Las Vegas, Nevada 89102
    United States

    Active - Recruiting

  • Lenox Hill Hospital

    New York, New York 10075
    United States

    Site Not Available

  • New York University

    New York, New York 10016
    United States

    Active - Recruiting

  • VA NY Harbor Healthcare System

    New York, New York 10010
    United States

    Terminated

  • St. Francis Hospital

    Roslyn, New York 11576
    United States

    Terminated

  • Stony Brook Medicine

    Stony Brook, New York 11794-8167
    United States

    Active - Recruiting

  • Lenox Hill Hospital

    New York 5128581, New York 5128638 10075
    United States

    Site Not Available

  • VA NY Harbor Healthcare System

    New York 5128581, New York 5128638 10010
    United States

    Site Not Available

  • Mission Hospital

    Asheville, North Carolina 28801
    United States

    Active - Recruiting

  • Duke University Hospital

    Durham, North Carolina 27705
    United States

    Active - Recruiting

  • NC Heart and Vascular Research

    Raleigh, North Carolina 27607
    United States

    Active - Recruiting

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • ProMedica Toledo Hospital

    Toledo, Ohio 43606
    United States

    Active - Recruiting

  • South Oklahoma Heart Research, LLC.

    Oklahoma City, Oklahoma 73135
    United States

    Active - Recruiting

  • Providence St. Vincent's Medical Center

    Portland, Oregon 97225
    United States

    Terminated

  • Pinnacle Health Cardiovascular Institute

    Harrisburg, Pennsylvania 17101
    United States

    Active - Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • Prisma Health - Midlands

    Colombia, South Carolina 29203
    United States

    Active - Recruiting

  • Monument Health

    Rapid City, South Dakota 57701
    United States

    Active - Recruiting

  • Stern Cardiovascular Foundation

    Germantown, Tennessee 38138
    United States

    Active - Recruiting

  • Tennova Healthcare - Turkey Creek Medical Center

    Knoxville, Tennessee 37934
    United States

    Active - Recruiting

  • Hendrick Health

    Abilene, Texas 79601
    United States

    Active - Recruiting

  • Austin Heart

    Austin, Texas 78756
    United States

    Active - Recruiting

  • UT Southwestern

    Dallas, Texas 75930
    United States

    Active - Recruiting

  • Baylor Scott & White Research Institute

    Plano, Texas 75093
    United States

    Active - Recruiting

  • NextStage Clinical Research

    Waco, Texas 76712
    United States

    Site Not Available

  • Waco Cardiology

    Waco, Texas 76712
    United States

    Active - Recruiting

  • University of Washington

    Seattle, Washington 98195
    United States

    Site Not Available

  • Advocate Aurora Health/Aurora Research Institute

    Milwaukee, Wisconsin 53215
    United States

    Site Not Available

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