Alleviant ALLAY-HF Study

Last updated: March 21, 2025
Sponsor: Alleviant Medical, Inc.
Overall Status: Active - Enrolling

Phase

N/A

Condition

Chest Pain

Congestive Heart Failure

Heart Failure

Treatment

Sham-Control

Alleviant ALV1 System

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: 500
Treatment Group(s): 2
Primary Treatment: Sham-Control
Phase:
Study Start date:
January 10, 2023
Estimated Completion Date:
July 31, 2032

Connect with a study center

  • Monash Health Victorian Heart Hospital

    Clayton, Victoria 3068
    Australia

    Site Not Available

  • Royal Adelaide Hospital

    Adelaide, 5000
    Australia

    Site Not Available

  • Medizinische Universität Graz

    Graz,
    Austria

    Site Not Available

  • OLV Hospital

    Aalst,
    Belgium

    Site Not Available

  • ZNA Middelheim

    Antwerpen,
    Belgium

    Site Not Available

  • AZ Sint Jan Brugge

    Bruges,
    Belgium

    Site Not Available

  • Southlake Regional Hospital Centre

    Newmarket, Ontario L3Y 2P6
    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)

    Montréal, Quebec H2X 0C1
    Canada

    Site Not Available

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

    Montréal, Quebec H2X 0C1
    Canada

    Site Not Available

  • Tbilisi Heart and Vascular

    Tbilisi,
    Georgia

    Site Not Available

  • Heart and Vascular Center-Bad Bevensen

    Bad Bevensen, 29549
    Germany

    Site Not Available

  • Herz- und Gefasszentrum Bad Bevensen

    Bad Bevensen, 29549
    Germany

    Site Not Available

  • Vivantes Klinikum im Friedrichshain

    Berlin, 10249
    Germany

    Site Not Available

  • St. Johannes Hospital

    Dortmund, 44137
    Germany

    Site Not Available

  • University of Gießen

    Gießen, 35392
    Germany

    Site Not Available

  • Askelepios Klinik Altona

    Hamburg, 22763
    Germany

    Site Not Available

  • Marienkrankenhaus

    Hamburg, 22087
    Germany

    Site Not Available

  • St. Vincentius Kliniken

    Karlsruhe, 76137
    Germany

    Site Not Available

  • Universitatsklinikum Schleswig-Holstein (UKSH)

    Luebeck, 23538
    Germany

    Site Not Available

  • Universitätsklinikum Kardiologie

    Magdeburg, 39120
    Germany

    Site Not Available

  • Universitatsmedizin Rostock

    Rostock, 18057
    Germany

    Site Not Available

  • European Interbalken Medical Center

    Thessaloníki,
    Greece

    Site Not Available

  • Shaare Zedek Medical Center

    Jerusalem,
    Israel

    Site Not Available

  • Tel Aviv Sourasky Medical Center

    Tel Aviv,
    Israel

    Site Not Available

  • Shamir Medical Center

    Zrifin,
    Israel

    Site Not Available

  • Humanitas Research Milan

    Rozzano, MI
    Italy

    Site Not Available

  • Instituto Auxologico Italiano

    Milan, 20149
    Italy

    Site Not Available

  • ChristChurch Hospital

    Christchurch, 8011
    New Zealand

    Site Not Available

  • Dunedin Hospital

    Dunedin, 9016
    New Zealand

    Site Not Available

  • Poznan University of Medical Sciences

    Poznań,
    Poland

    Site Not Available

  • 4th Military Hospital

    Wrocław,
    Poland

    Site Not Available

  • Uniwesytecki Szpital Kliniczny

    Wrocław,
    Poland

    Site Not Available

  • Silesian Center for Heart Disease

    Zabrze,
    Poland

    Site Not Available

  • Barcelona Hospital del Mar

    Barcelona, 08033
    Spain

    Site Not Available

  • Germans Trias i Pujol

    Barcelona, 08916
    Spain

    Site Not Available

  • Hospital Clinic de Barcelona

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025
    Spain

    Site Not Available

  • Cadiz Hospital Universitario Puerta del Mar

    Cadiz, 11009
    Spain

    Site Not Available

  • Hospital Universitario Puerta de Hierro

    Madrid, 28222
    Spain

    Site Not Available

  • Hospital Clínico Universitario de Salamanca

    Salamanca,
    Spain

    Site Not Available

  • Valencia Hospital Clinico

    Valencia, 46010
    Spain

    Site Not Available

  • University of Alabama

    Birmingham, Alabama 35249
    United States

    Site Not Available

  • Arizona Cardiovascular Research Center

    Phoenix, Arizona 85016
    United States

    Site Not Available

  • Honor Health

    Scottsdale, Arizona 85258
    United States

    Site Not Available

  • Pima Heart and Vascular

    Tucson, Arizona 85718
    United States

    Site Not Available

  • Memorial Care Long Beach Medical Center

    Long Beach, California 90806
    United States

    Site Not Available

  • Scripps Clinical Research Services

    San Diego, California 92121
    United States

    Site Not Available

  • San Francisco VA

    San Francisco, California 94121
    United States

    Site Not Available

  • University of California San Francisco

    San Francisco, California 94143
    United States

    Site Not Available

  • Santa Barbara Cottage Hospital

    Santa Barbara, California 93105
    United States

    Site Not Available

  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA-Medical Center

    Torrance, California 90502
    United States

    Site Not Available

  • Hartford Hospital

    Hartford, Connecticut 06106
    United States

    Site Not Available

  • The Cardiac and Vascular Institute (TCAVI)

    Gainesville, Florida 32504
    United States

    Site Not Available

  • HCA Florida Memorial Hospital

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • University of Florida Jacksonville

    Jacksonville, Florida 32206
    United States

    Site Not Available

  • NCH Research Institute

    Naples, Florida 34102
    United States

    Site Not Available

  • Advent Health Orlando

    Orlando, Florida 32803
    United States

    Site Not Available

  • Ascension Sacred Heart

    Pensacola, Florida 32504
    United States

    Site Not Available

  • Atlanta VA Health Care System

    Decatur, Georgia 30032
    United States

    Site Not Available

  • Advocate Illinois Masonic Medical Center

    Chicago, Illinois 60657
    United States

    Site Not Available

  • Midwest Cardiovascular Institute

    Naperville, Illinois 60540
    United States

    Site Not Available

  • Prairie Education and Research Cooperative

    Springfield, Illinois 62769
    United States

    Site Not Available

  • Indiana University

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • St. Elizabeth Healthcare

    Edgewood, Kentucky 41017
    United States

    Site Not Available

  • Baptist Health Louisville Cardiology Research

    Louisville, Kentucky 402207
    United States

    Site Not Available

  • Cardiovascular Institute of the South

    Houma, Louisiana 70360
    United States

    Site Not Available

  • University Medical Center New Orleans

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • Johns Hopkins Medical Institution

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Boston Medical Center

    Boston, Massachusetts 02118
    United States

    Site Not Available

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Steward St. Elizabeth's Medical Center

    Brighton, Massachusetts 02135
    United States

    Site Not Available

  • VA Ann Arbor

    Ann Arbor, Michigan 48105
    United States

    Site Not Available

  • Ascension St. John Hospital

    Detroit, Michigan 48236
    United States

    Site Not Available

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota 55407
    United States

    Site Not Available

  • The Valley Hospital

    Ridgewood, New Jersey 07450
    United States

    Site Not Available

  • Lenox Hill Hospital

    New York, New York 10075
    United States

    Site Not Available

  • New York University

    New York, New York 10016
    United States

    Site Not Available

  • VA NY Harbor Healthcare System

    New York, New York 10010
    United States

    Site Not Available

  • St. Francis Hospital

    Roslyn, New York 11576
    United States

    Site Not Available

  • Stony Brook Medicine

    Stony Brook, New York 11794-8167
    United States

    Site Not Available

  • Mission Hospital

    Asheville, North Carolina 28801
    United States

    Site Not Available

  • Duke University Hospital

    Durham, North Carolina 27705
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • The MetroHealth System

    Cleveland, Ohio 44109
    United States

    Site Not Available

  • Mount Carmel Health System

    Columbus, Ohio 43213
    United States

    Site Not Available

  • ProMedica Toledo Hospital

    Toledo, Ohio 43606
    United States

    Site Not Available

  • South Oklahoma Heart Research, LLC.

    Oklahoma City, Oklahoma 73135
    United States

    Site Not Available

  • Providence St. Vincent's Medical Center

    Portland, Oregon 97225
    United States

    Site Not Available

  • Pinnacle Health Cardiovascular Institute

    Harrisburg, Pennsylvania 17101
    United States

    Site Not Available

  • Prisma Health - Midlands

    Colombia, South Carolina 29203
    United States

    Site Not Available

  • Prisma Health - Midlands

    Columbia, South Carolina 29203
    United States

    Site Not Available

  • Monument Health

    Rapid City, South Dakota 57701
    United States

    Site Not Available

  • Stern Cardiovascular Foundation

    Germantown, Tennessee 38138
    United States

    Site Not Available

  • Tennova Healthcare - Turkey Creek Medical Center

    Knoxville, Tennessee 37934
    United States

    Site Not Available

  • Hendrick Health

    Abilene, Texas 79601
    United States

    Site Not Available

  • Austin Heart

    Austin, Texas 78756
    United States

    Site Not Available

  • UT Southwestern

    Dallas, Texas 75930
    United States

    Site Not Available

  • Texas Tech University Health Sciences Center

    Lubbock, Texas 79430
    United States

    Site Not Available

  • Baylor Scott & White Research Institute

    Plano, Texas 75093
    United States

    Site Not Available

  • NextStage Clinical Research

    Waco, Texas 76712
    United States

    Site Not Available

  • 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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