Alleviant ALLAY-HFrEF Study

August 12, 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

Recruiting

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 Contact

Study Locations

  • Australia
    • Victoria
      • Clayton, Victoria, Australia, 3068
        • Recruiting
        • Monash Health Victorian Heart Hospital
        • Principal Investigator:
          • Robert Gooley
      • Melbourne, Victoria, Australia, 3004
        • Recruiting
        • Alfred Hospital
        • Principal Investigator:
          • David Kaye
  • Belgium
      • Aalst, Belgium
        • Recruiting
        • OLV Hospital
        • Principal Investigator:
          • Jozef Bartunek, Prof.
      • Antwerp, Belgium
        • Recruiting
        • ZAS Middelheim
        • Principal Investigator:
          • Stefan Verheye
      • Bruges, Belgium
        • Recruiting
        • Az Sint Jan Brugge
        • Principal Investigator:
          • Jan Van der Heyden, Prof.
  • Canada
    • Ontario
      • Newmarket, Ontario, Canada, L3Y 2P6
        • Recruiting
        • Southlake Regional Hospital Centre
        • Principal Investigator:
          • Liane Porepa, MD
    • Quebec
      • Montreal, Quebec, Canada, H2X 0C1
        • Recruiting
        • Centre Hospitalier de l'Universite de Montreal (CHUM)
        • Principal Investigator:
          • Brian Potter, MD
      • Montreal, Quebec, Canada, H2X 0C1
        • Recruiting
        • Centre Integre Universitaire de Sainte et de Services Scoiiaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CIUSSS de l'Estrie - CHUS)
        • Principal Investigator:
          • Benoit Daneault, MD
      • Québec, Quebec, Canada, G1V 4G5
        • Recruiting
        • IUCPQ - Université Laval (Quebec)
        • Principal Investigator:
          • Josep Rodés-Cabau, MD, PhD
  • Georgia
      • Tbilisi, Georgia
        • Recruiting
        • Tbilisi Heart and Vascular
        • Principal Investigator:
          • Tamaz Shaburishvili
  • Greece
      • Athens, Greece, 15123
        • Recruiting
        • Hygeia Hospital
        • Principal Investigator:
          • Elias Tsougos
      • Athens, Greece, 11527
        • Recruiting
        • Hippocration General Hospital Athens
        • Principal Investigator:
          • Konstantinos Toutouzas
      • Thessaloniki, Greece
        • Recruiting
        • European Interbalken Medical Center
        • Principal Investigator:
          • Vlasis Ninios
  • Israel
      • Tel Aviv, Israel
        • Recruiting
        • Tel Aviv Sourasky Medical Center
        • Principal Investigator:
          • Michael Laufer-Perl
      • Zrifin, Israel
        • Recruiting
        • Shamir Medical Center
        • Principal Investigator:
          • Gil Moravsky
  • New Zealand
      • Christchurch, New Zealand, 8011
        • Recruiting
        • Christchurch Hospital
        • Principal Investigator:
          • Richard Troughton
      • Dunedin, New Zealand, 9016
        • Recruiting
        • Dunedin Hospital
        • Principal Investigator:
          • Gerard Wilkins
  • Poland
      • Opole, Poland
        • Recruiting
        • University Clinical Hospital in Opole
        • Principal Investigator:
          • Jerzy Sacha
      • Warsaw, Poland
        • Recruiting
        • Narodowy Instytut Kardiologii im. Stefana kardynała Wyszyńsk
        • Principal Investigator:
          • Przemysław Leszek
      • Wroclaw, Poland
        • Recruiting
        • Uniwesytecki Szpital Kliniczny
        • Principal Investigator:
          • Jan Biegus, Prof.
  • Spain
      • A Coruña, Spain
        • Recruiting
        • Hospital Universitario A Coruña
        • Principal Investigator:
          • Maria Generosa Crespo Leiro, Prof.
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic de Barcelona
        • Principal Investigator:
          • Omar Abdul-Jawad Altisent
      • Barcelona, Spain, 08025
        • Recruiting
        • Hospital de la Santa Creu i Sant Pau
        • Principal Investigator:
          • Sonia Mirabet, MD, PhD
      • Barcelona, Spain
        • Recruiting
        • Vall d'Hebron University Hospital Barcelona
        • Principal Investigator:
          • Eduardo Rodenas-Alesina
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
        • Principal Investigator:
          • Javier de Juan Bagudá
      • Madrid, Spain, 28222
        • Recruiting
        • Hospital Universitario Puerta de Hierro
        • Principal Investigator:
          • Marta Cobo Marcos, Prof.
      • Salamanca, Spain
        • Recruiting
        • Hospital Clínico Universitario de Salamanca
        • Principal Investigator:
          • David González Calle, MD
      • Valencia, Spain, 46010
        • Recruiting
        • Valencia Hospital Clinico
        • Principal Investigator:
          • Julio Nunez
  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Recruiting
        • Keck Medical Center of USC
        • Principal Investigator:
          • Michael Fong, MD
      • Los Angeles, California, United States, 90095
        • Recruiting
        • University California Los Angeles Medical Center
        • Principal Investigator:
          • Richard Cheng, MD
      • Sacramento, California, United States, 95817
        • Recruiting
        • UC Davis Medical Center
        • Principal Investigator:
          • Tai Pham, MD
      • San Diego, California, United States, 92121
        • Recruiting
        • Scripps Clinical Research Services
        • Principal Investigator:
          • Rajeev Mohan, MD
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California San Francisco
        • Principal Investigator:
          • Liviu Klein, MD
    • Florida
      • Delray Beach, Florida, United States, 33484
        • Recruiting
        • Delray Medical Center
        • Principal Investigator:
          • Philip Habib, MD
      • Pensacola, Florida, United States, 32504
        • Recruiting
        • Ascension Sacred Heart
        • Principal Investigator:
          • Rohit Amin, MD
      • Tampa, Florida, United States, 33606
        • Recruiting
        • Tampa General Hospital
        • Principal Investigator:
          • Jason Feliberti, MD
    • Georgia
      • Decatur, Georgia, United States, 30032
        • Recruiting
        • Atlanta VA Health Care System
        • Principal Investigator:
          • Gautum Kumar, MD
    • Illinois
      • Naperville, Illinois, United States, 60540
        • Recruiting
        • Midwest Cardiovascular Institute
        • Principal Investigator:
          • Stanislaw Skaluba, MD
    • Louisiana
      • Houma, Louisiana, United States, 70360
        • Recruiting
        • Cardiovascular Institute of the South
        • Principal Investigator:
          • Peter Fail, MD
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • University Medical Center New Orleans
        • Principal Investigator:
          • Frank Smart, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham and Women's Hospital
        • Principal Investigator:
          • Pinak Shah, MD
      • Boston, Massachusetts, United States, 02118
        • Recruiting
        • Boston Medical Center
        • Principal Investigator:
          • Nir Ayalon, MD
      • Boston, Massachusetts, United States, 02111
        • Recruiting
        • Tufts Medical Center
        • Principal Investigator:
          • Jeong Hwan Kim, MD
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • Minneapolis Heart Institute Foundation
        • Principal Investigator:
          • Peter Eckman, MD
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University - St Louis
        • Principal Investigator:
          • Ali Javaheri, MD, PhD
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Recruiting
        • UMC of Southern Nevada
        • Principal Investigator:
          • Ahsan Chowdhury
    • New Jersey
      • Browns Mills, New Jersey, United States, 08015
        • Recruiting
        • Deborah Heart & Lung Center
        • Principal Investigator:
          • Geurys Rojas-Marte
      • Englewood, New Jersey, United States, 07631
        • Recruiting
        • Englewood Medical Center
        • Principal Investigator:
          • Ramin Hastings
    • New York
      • New York, New York, United States, 11794
        • Recruiting
        • Stony Brook Medicine
        • Principal Investigator:
          • Ahmad Alkhalil, MD
      • Rochester, New York, United States, 14621
        • Recruiting
        • Rochester General Hospital
        • Principal Investigator:
          • Elizabeth Lee, MD
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Recruiting
        • Mission Hospital
        • Principal Investigator:
          • Vinay Thohan, MD
      • Durham, North Carolina, United States, 27705
        • Recruiting
        • Duke University Hospital
        • Principal Investigator:
          • Robert Mentz, MD, FACC, FAHA, HFSA
      • Raleigh, North Carolina, United States, 27607
        • Recruiting
        • NC Heart and Vascular Research
        • Principal Investigator:
          • Elizabeth Volz, MD
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Principal Investigator:
          • J. Emanuel Finet, MD
      • Toledo, Ohio, United States, 43606
        • Recruiting
        • ProMedica Toledo Hospital
        • Principal Investigator:
          • P. Kasi Ramanathan, MD
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17101
        • Recruiting
        • Pinnacle Health Cardiovascular Institute
        • Principal Investigator:
          • Hemal Gada, MD
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Principal Investigator:
          • Brian Houston, MD
      • Charleston, South Carolina, United States, 29414
        • Recruiting
        • Roper St. Francis Healthcare
        • Principal Investigator:
          • Matthew O'Steen, MD
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Recruiting
        • Monument Health
        • Principal Investigator:
          • Luis Hernandez, MD
    • Tennessee
      • Knoxville, Tennessee, United States, 37934
        • Recruiting
        • Tennova Healthcare - Turkey Creek Medical Center
        • Principal Investigator:
          • Malcolm Foster
    • Texas
      • Abilene, Texas, United States, 79601
        • Recruiting
        • Hendrick Health
        • Principal Investigator:
          • Mark Lawrence, D.O.
      • Austin, Texas, United States, 78756
        • Recruiting
        • Austin Heart
        • Principal Investigator:
          • Kunjan Bhatt, MD
      • Austin, Texas, United States, 78705
        • Recruiting
        • Texas Cardiac Arrhythmia Research Foundation
        • Principal Investigator:
          • Huseng Vefali, MD
      • Plano, Texas, United States, 75093
        • Recruiting
        • Baylor Scott & White Research Institute
        • Principal Investigator:
          • Molly Szerlip
      • Temple, Texas, United States, 76508
        • Recruiting
        • Baylor Scott & White - Temple
        • Principal Investigator:
          • Ernesto Ruiz Duque, MD
      • Waco, Texas, United States, 76712
        • Recruiting
        • Waco Cardiology
        • Principal Investigator:
          • Donald Cross, MD
    • Virginia
      • Roanoke, Virginia, United States, 24014
        • Recruiting
        • Carilion Clinic
        • Principal Investigator:
          • Daniel Pauly, MD

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)

August 14, 2026

Last Update Submitted That Met QC Criteria

August 12, 2026

Last Verified

August 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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