Alleviant ALLAY-HFrEF Study

June 2, 2026 updated by: Alleviant Medical, Inc.

Safety and Efficacy of the Alleviant No-Implant Interatrial Shunt in Patients With Heart Failure and Reduced Ejection Fraction

Prospective, multicenter, randomized, sham-controlled, double blind (patient and observer), study designed to evaluate the safety and efficacy of a percutaneously created interatrial shunt using the Alleviant ALV1 System in patients with HFrEF.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

350

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
      • Melbourne, Victoria, Australia, 3004
        • Alfred Hospital
  • Belgium
      • Aalst, Belgium
        • OLV Hospital
      • Antwerp, Belgium
        • ZAS Middelheim
      • Bruges, Belgium
        • Az Sint Jan Brugge
  • Canada
      • Québec, Canada, G1V 4G5
        • IUCPQ - Université Laval (Quebec)
    • 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)
  • Georgia
      • Tbilisi, Georgia
        • Tbilisi Heart and Vascular
  • Greece
      • Athens, Greece, 15123
        • Hygeia Hospital
      • Thessaloniki, Greece
        • European Interbalken Medical Center
  • Israel
      • Tel Aviv, Israel
        • Tel Aviv Sourasky Medical Center
      • Zrifin, Israel
        • Shamir Medical Center
  • New Zealand
      • Christchurch, New Zealand, 8011
        • Christchurch Hospital
      • Dunedin, New Zealand, 9016
        • Dunedin Hospital
  • Poland
      • Opole, Poland
        • University Clinical Hospital in Opole
      • Warsaw, Poland
        • Narodowy Instytut Kardiologii im. Stefana kardynała Wyszyńsk
      • Wroclaw, Poland
        • Uniwesytecki Szpital Kliniczny
  • Spain
      • A Coruña, Spain
        • Hospital Universitario A Coruña
      • Barcelona, Spain, 08025
        • Hospital De La Santa Creu I Sant Pau
      • Barcelona, Spain
        • Vall d'Hebron University Hospital Barcelona
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro
      • Salamanca, Spain
        • Hospital Clinico Universitario de Salamanca
      • Valencia, Spain, 46010
        • Valencia Hospital Clinico
  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Keck Medical Center of USC
      • 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
    • Florida
      • Delray Beach, Florida, United States, 33484
        • Delray Medical Center
      • Pensacola, Florida, United States, 32504
        • Ascension Sacred Heart
      • Tampa, Florida, United States, 33606
        • Tampa General Hospital
    • Georgia
      • Decatur, Georgia, United States, 30032
        • Atlanta VA Health Care System
    • Illinois
      • Naperville, Illinois, United States, 60540
        • Midwest Cardiovascular Institute
    • Louisiana
      • Houma, Louisiana, United States, 70360
        • Cardiovascular Institute of the South
      • New Orleans, Louisiana, United States, 70112
        • University Medical Center New Orleans
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center
    • 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, 11794
        • Stony Brook Medicine
      • Rochester, New York, United States, 14621
        • Rochester General Hospital
    • 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
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17101
        • Pinnacle Health Cardiovascular Institute
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
      • Charleston, South Carolina, United States, 29414
        • Roper St. Francis Healthcare
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Monument Health
    • Tennessee
      • Knoxville, Tennessee, United States, 37934
        • Tennova Healthcare - Turkey Creek Medical Center
    • Texas
      • Abilene, Texas, United States, 79601
        • Hendrick Health
      • Austin, Texas, United States, 78705
        • Texas Cardiac Arrhythmia Research Foundation
      • Austin, Texas, United States, 78756
        • Austin Heart
      • Plano, Texas, United States, 75093
        • Baylor Scott & White Research Institute
      • Temple, Texas, United States, 76508
        • Baylor Scott & White - Temple
      • Waco, Texas, United States, 76712
        • NextStage Clinical Research
    • Virginia
      • Roanoke, Virginia, United States, 24014
        • Carilion Clinic

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

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 all-cause mortality or cardiac transplantation or permanent left ventricular assist device (LVAD) and heart failure events.
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: Gregg Stone, Icahn School of Medicine at Mount Sinai
  • Principal Investigator: James Udelson, 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)

March 10, 2025

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

February 3, 2025

First Submitted That Met QC Criteria

February 3, 2025

First Posted (Actual)

February 6, 2025

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP-0006

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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