Alleviant ALLAY-HF Study

April 30, 2026 updated by: Alleviant Medical, Inc.

Safety and Efficacy of the Alleviant System for No-Implant Interatrial Shunt Creation in Patients With Chronic Heart Failure

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

700

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Clayton, Victoria, Australia, 3068
        • Monash Health Victorian Heart Hospital
      • Heidelberg, Victoria, Australia, 3084
        • Austin Hospital
  • Austria
      • Graz, Austria
        • Medizinische Universität Graz
  • Belgium
      • Aalst, Belgium
        • OLV Hospital
      • Antwerp, Belgium
        • ZAS Middelheim
      • Bruges, Belgium
        • AZ Sint Jan Brugge
  • Bulgaria
      • Plovdiv, Bulgaria, 4002
        • University Hospital UMHAT Sveti Georgi
      • Sofia, Bulgaria, 1407
        • Acibadem City Clinic University Tokuda Hospital
      • Sofia, Bulgaria, 1700
        • Acibadem City Clinic Cardiovascular Center Sofia
  • Canada
    • Ontario
      • Newmarket, Ontario, Canada, L3Y 2P6
        • Southlake Regional Hospital Centre
    • Quebec
      • Montreal, Quebec, Canada, H2X 0C1
        • Centre Hospitalier de l'Universite de Montreal (CHUM)
      • Montreal, Quebec, Canada, H2X 0C1
        • Centre Integre Universitaire de Sainte et de Services Scoiiaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CIUSSS de l'Estrie - CHUS)
  • Czechia
      • Třinec, Czechia, 73961
        • Kardiocentrum Nemocnice AGEL Trinec-Podlesi
  • Georgia
      • Tbilisi, Georgia
        • Tbilisi Heart and Vascular
  • Germany
      • Bad Bevensen, Germany, 29549
        • Herz- und Gefasszentrum Bad Bevensen
      • Bad Bevensen, Germany, 29549
        • Heart and Vascular Center-Bad Bevensen
      • Giessen, Germany, 35392
        • University of Gießen
      • Hamburg, Germany, 22087
        • Marienkrankenhaus
      • Hamburg, Germany, 22763
        • Askelepios Klinik Altona
      • Karlsruhe, Germany, 76137
        • St. Vincentius Kliniken
      • Lübeck, Germany, 23538
        • Universitätsklinikum Schleswig-Holstein (UKSH)
      • Magdeburg, Germany, 39120
        • Universitätsklinikum Kardiologie
      • Rostock, Germany, 18057
        • Universitätsmedizin Rostock
  • Greece
      • Thessaloniki, Greece
        • European Interbalken Medical Center
  • Israel
      • Jerusalem, Israel
        • Shaare Zedek Medical Center
      • Tel Aviv, Israel
        • Tel Aviv Sourasky Medical Center
      • Zrifin, Israel
        • Shamir Medical Center
  • Italy
      • Milan, Italy, 20149
        • Instituto Auxologico Italiano
    • MI
      • Rozzano, MI, Italy
        • Humanitas Research Milan
  • New Zealand
      • Christchurch, New Zealand, 8011
        • Christchurch Hospital
      • Dunedin, New Zealand, 9016
        • Dunedin Hospital
  • Poland
      • Opole, Poland
        • University Clinical Hospital in Opole
      • Poznan, Poland
        • Poznan University of Medical Sciences
      • Wejherowo, Poland, 84-200
        • Kashubian Center for Heart and Vascular Diseases, Pomeranian
      • Wroclaw, Poland
        • 4th Military Hospital
      • Wroclaw, Poland
        • Uniwesytecki Szpital Kliniczny
      • Zabrze, Poland
        • Silesian Center for Heart Disease
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic De Barcelona
      • Barcelona, Spain, 08025
        • Hospital De La Santa Creu I Sant Pau
      • Barcelona, Spain, 08033
        • Barcelona Hospital del Mar
      • Barcelona, Spain
        • Vall d'Hebron University Hospital Barcelona
      • Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro
      • Salamanca, Spain
        • Hospital Clinico Universitario de Salamanca
      • Valencia, Spain, 46010
        • Valencia Hospital Clinico
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • University of Alabama
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Arizona Cardiovascular Research Center
      • Tucson, Arizona, United States, 85718
        • Pima Heart and Vascular
    • California
      • Long Beach, California, United States, 90806
        • Memorial Care Long Beach Medical Center
      • Sacramento, California, United States, 95817
        • UC Davis Medical Center
      • San Diego, California, United States, 92121
        • Scripps Clinical Research Services
      • San Francisco, California, United States, 94143
        • University of California San Francisco
      • San Francisco, California, United States, 94121
        • San Francisco VA
      • Santa Barbara, California, United States, 93105
        • Santa Barbara Cottage Hospital
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Hartford Hospital
    • Florida
      • Gainesville, Florida, United States, 32504
        • The Cardiac and Vascular Institute (TCAVI)
      • Jacksonville, Florida, United States, 32216
        • HCA Florida Memorial Hospital
      • Naples, Florida, United States, 34102
        • NCH Research Institute
      • Orlando, Florida, United States, 32803
        • Advent Health Orlando
      • Pensacola, Florida, United States, 32504
        • Ascension Sacred Heart
    • Georgia
      • Decatur, Georgia, United States, 30032
        • Atlanta VA Health Care System
    • Illinois
      • Chicago, Illinois, United States, 60657
        • Advocate Illinois Masonic Medical Center
      • Naperville, Illinois, United States, 60540
        • Midwest Cardiovascular Institute
      • Springfield, Illinois, United States, 62769
        • Prairie Education and Research Cooperative
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • St. Elizabeth Healthcare
    • Louisiana
      • Houma, Louisiana, United States, 70360
        • Cardiovascular Institute of the South
      • New Orleans, Louisiana, United States, 70112
        • University Medical Center New Orleans
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Medical Institution
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • VA Ann Arbor
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Minneapolis Heart Institute Foundation
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University - St Louis
    • New York
      • New York, New York, United States, 10016
        • New York University
      • New York, New York, United States, 10075
        • Lenox Hill Hospital
      • New York, New York, United States, 10010
        • VA NY Harbor Healthcare System
      • Roslyn, New York, United States, 11576
        • St. Francis Hospital
      • Stony Brook, New York, United States, 11794-8167
        • Stony Brook Medicine
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Mission Hospital
      • Durham, North Carolina, United States, 27705
        • Duke University Hospital
      • Raleigh, North Carolina, United States, 27607
        • NC Heart and Vascular Research
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Toledo, Ohio, United States, 43606
        • ProMedica Toledo Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73135
        • South Oklahoma Heart Research, LLC.
    • Oregon
      • Portland, Oregon, United States, 97225
        • Providence St. Vincent's Medical Center
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17101
        • Pinnacle Health Cardiovascular Institute
    • South Carolina
      • Columbia, South Carolina, United States, 29203
        • Prisma Health - Midlands
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Monument Health
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Stern Cardiovascular Foundation
      • Knoxville, Tennessee, United States, 37934
        • Tennova Healthcare - Turkey Creek Medical Center
    • Texas
      • Abilene, Texas, United States, 79601
        • Hendrick Health
      • Austin, Texas, United States, 78756
        • Austin Heart
      • Dallas, Texas, United States, 75930
        • UT Southwestern
      • Plano, Texas, United States, 75093
        • Baylor Scott & White Research Institute
      • Waco, Texas, United States, 76712
        • NextStage Clinical Research
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Advocate Aurora Health/Aurora Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Subjects randomized to the treatment arm will undergo cardiac imaging, femoral vein access and receive the Alleviant ALV1 System device procedure.
Device: Alleviant ALV1 System
Creation of interatrial shunt
Sham Comparator: Control
Subjects randomized to the control arm will undergo cardiac imaging and sheath placement in femoral vein.
Other: Sham-Control
Cardiac imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite Primary Endpoint
Time Frame: 12-month
The primary endpoint is a composite of mortality, heart failure events and quality of life based on Kansas City Cardiomyopathy Questionnaire (KCCQ) calculated at 12 months. KCCQ responses are provided along a rating scale from 0-100 with a higher score indicating better health.
12-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alleviant Medical, Inc.

Investigators

  • Principal Investigator: James Udelson, MD, Tufts Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2023

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2032

Study Registration Dates

First Submitted

December 14, 2022

First Submitted That Met QC Criteria

January 5, 2023

First Posted (Actual)

January 17, 2023

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP-0003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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