Alleviant ALLAY-HFrEF Study

September 15, 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
350

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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
      • Québec, Canada, G1V 4G5
        • Recruiting
        • IUCPQ - Université Laval (Quebec)
        • Principal Investigator:
          • Josep Rodés-Cabau, MD, PhD
    • 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'Université de Montréal (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
  • 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 Coruna
        • 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, 28222
        • Recruiting
        • Hospital Universitario Puerta De Hierro
        • Principal Investigator:
          • Marta Cobo Marcos, Prof.
      • Madrid, Spain, 28041
        • Terminated
        • Hospital Universitario 12 de Octubre
      • Salamanca, Spain
        • Recruiting
        • Hospital Clinico 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
      • Rochester, New York, United States, 14642
        • Not yet recruiting
        • University of Rochester Medical Center
        • Principal Investigator:
          • Denizhan Ozdemir, MD, PhD
    • 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
        • Terminated
        • Texas Cardiac Arrhythmia Research Foundation
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alleviant Medical, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 10, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 3, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 6, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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