Alleviant ALLAY-HF Study

August 12, 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

Recruiting

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 Contact

Study Locations

  • Australia
    • Victoria
      • Clayton, Victoria, Australia, 3068
        • Recruiting
        • Monash Health Victorian Heart Hospital
        • Principal Investigator:
          • Robert Gooley, A/Prof
      • Heidelberg, Victoria, Australia, 3084
        • Recruiting
        • Austin Hospital
        • Principal Investigator:
          • Matias Yudi
  • Austria
      • Graz, Austria
        • Recruiting
        • MEDIZINISCHE UNIVERSITAT GRAZ
        • Principal Investigator:
          • Gabor Toth, MD, PhD
  • Belgium
      • Aalst, Belgium
        • Recruiting
        • OLV Hospital
        • Principal Investigator:
          • Martin Penicka, MD, PhD
      • Antwerp, Belgium
        • Recruiting
        • ZAS Middelheim
        • Principal Investigator:
          • Stefan Verheye
      • Bruges, Belgium
        • Recruiting
        • AZ Sint Jan Brugge
        • Principal Investigator:
          • Jan Van der Heyden, MD, PhD
  • Bulgaria
      • Plovdiv, Bulgaria, 4002
        • Recruiting
        • University Hospital UMHAT Sveti Georgi
        • Principal Investigator:
          • Krasimir Dzhinsov
  • 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'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
  • Czechia
      • Třinec, Czechia, 73961
        • Recruiting
        • Kardiocentrum Nemocnice AGEL Trinec-Podlesi
        • Principal Investigator:
          • Jaroslav Januska
  • Georgia
      • Tbilisi, Georgia
        • Recruiting
        • Tbilisi Heart and Vascular
        • Principal Investigator:
          • Tamaz Shaburishvili
  • Germany
      • Hamburg, Germany, 22087
        • Terminated
        • Marienkrankenhaus
      • Lübeck, Germany, 23538
        • Recruiting
        • Universitätsklinikum Schleswig-Holstein (UKSH)
        • Principal Investigator:
          • Tobias Schmidt, MD
      • Magdeburg, Germany, 39120
        • Recruiting
        • Universitätsklinikum Kardiologie
        • Principal Investigator:
          • Rüdiger Braun-Dullaeus, MD, PhD
  • Israel
      • Jerusalem, Israel
        • Terminated
        • Shaare Zedek Medical Center
      • Tel Aviv, Israel
        • Recruiting
        • Tel Aviv Sourasky Medical Center
        • Principal Investigator:
          • Michal Laufer-Perl, MD
      • Zrifin, Israel
        • Recruiting
        • Shamir Medical Center
        • Principal Investigator:
          • Gil Moravsky, MD
  • Italy
      • Milan, Italy, 20149
        • Recruiting
        • Instituto Auxologico Italiano
        • Principal Investigator:
          • Sergio Caravita, MD, PhD
    • Michigan
      • Rozzano, Michigan, Italy
        • Terminated
        • Humanitas Research Milan
  • New Zealand
      • Christchurch, New Zealand, 8011
        • Recruiting
        • Christchurch Hospital
        • Principal Investigator:
          • Richard Troughton, PhD
      • Dunedin, New Zealand, 9016
        • Recruiting
        • Dunedin Hospital
        • Principal Investigator:
          • Gerry Wilkins, A/Prof
  • Poland
      • Opole, Poland
        • Recruiting
        • University Clinical Hospital in Opole
        • Principal Investigator:
          • Jerzy Sacha
      • Poznan, Poland
        • Recruiting
        • Poznan University of Medical Sciences
        • Principal Investigator:
          • Marek Grygier, MD, PhD
      • Wejherowo, Poland, 84-200
        • Recruiting
        • Kashubian Center for Heart and Vascular Diseases, Pomeranian
        • Principal Investigator:
          • Lukasz Lewicki
      • Wroclaw, Poland
        • Recruiting
        • Uniwesytecki Szpital Kliniczny
        • Principal Investigator:
          • Jan Leon Biegus, MD, PhD
      • Wroclaw, Poland
        • Recruiting
        • 4th Military Hospital
        • Principal Investigator:
          • Bartek Krakowiak, MD, PhD
      • Zabrze, Poland
        • Recruiting
        • Silesian Center for Heart Disease
        • Principal Investigator:
          • Michal Hawranek
  • Spain
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic de Barcelona
        • Principal Investigator:
          • Omar Abdul-Jawad Altisent, MD, PhD
      • Barcelona, Spain, 08025
        • Recruiting
        • Hospital De La Santa Creu I Sant Pau
        • Principal Investigator:
          • Sonia Mirabel, MD, PhD
      • Barcelona, Spain
        • Recruiting
        • Vall d'Hebron University Hospital Barcelona
        • Principal Investigator:
          • Eduard Ródenas-Alesina
      • Barcelona, Spain, 08033
        • Recruiting
        • Barcelona Hospital del Mar
        • Principal Investigator:
          • Nuria Farre, MD
      • Barcelona, Spain, 08916
        • Terminated
        • Germans Trias i Pujol University Hospital
      • Cadiz, Spain, 11009
        • Terminated
        • Hospital Universitario Puerta del Cadíz
      • Madrid, Spain, 28222
        • Recruiting
        • Hospital Universitario Puerta de Hierro
        • Principal Investigator:
          • Marta Cobo Marcos, MD
      • Salamanca, Spain
        • Recruiting
        • Hospital Clinico Universitario de Salamanca
        • Principal Investigator:
          • Inès Maria Toranzo Nieto
      • Valencia, Spain, 46010
        • Recruiting
        • Valencia Hospital Clinico
        • Principal Investigator:
          • Julio Nunez, MD, PhD
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Active, not recruiting
        • Arizona Cardiovascular Research Center
      • Scottsdale, Arizona, United States, 85258
        • Terminated
        • HonorHealth
      • Tucson, Arizona, United States, 85718
        • Recruiting
        • Pima Heart and Vascular
        • Principal Investigator:
          • Thomas Waggoner, DO
    • California
      • Long Beach, California, United States, 90806
        • Recruiting
        • Memorial Care Long Beach Medical Center
        • Principal Investigator:
          • Kevin Shah, 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:
          • Richard Cheng, MD
      • Santa Barbara, California, United States, 93105
        • Recruiting
        • Santa Barbara Cottage Hospital
        • Principal Investigator:
          • Joseph Aragon, MD
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Terminated
        • Hartford Hospital
    • Florida
      • Gainesville, Florida, United States, 32504
        • Recruiting
        • The Cardiac and Vascular Institute (TCAVI)
        • Principal Investigator:
          • Ann Tong, MD
      • Jacksonville, Florida, United States, 32216
        • Recruiting
        • HCA Florida Memorial Hospital
        • Principal Investigator:
          • Amir Azarbal, MD
      • Naples, Florida, United States, 34102
        • Recruiting
        • NCH Research Institute
        • Principal Investigator:
          • Mazen Albaghdadi, MD
      • Orlando, Florida, United States, 32803
        • Recruiting
        • Advent Health Orlando
        • Principal Investigator:
          • Rohit Bhatheja, MD
      • Pensacola, Florida, United States, 32504
        • Recruiting
        • Ascension Sacred Heart
        • Principal Investigator:
          • Rohit Amin, MD
    • Georgia
      • Decatur, Georgia, United States, 30032
        • Recruiting
        • Atlanta VA Health Care System
        • Principal Investigator:
          • Gautum Kumar, MD
    • Illinois
      • Chicago, Illinois, United States, 60657
        • Terminated
        • Advocate Illinois Masonic Medical Center
      • Naperville, Illinois, United States, 60540
        • Recruiting
        • Midwest Cardiovascular Institute
        • Principal Investigator:
          • Maria Rosa Costanzo, MD
      • Springfield, Illinois, United States, 62769
        • Active, not recruiting
        • Prairie Education And Research Cooperative
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University
        • Principal Investigator:
          • Sujal Modi, MD
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • Recruiting
        • St. Elizabeth Healthcare
        • Principal Investigator:
          • Benjamin Peterson, 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
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins Medical Institution
        • Principal Investigator:
          • Kavita Sharma, 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:
          • Deepa Gopal, MD
      • Brighton, Massachusetts, United States, 02135
        • Terminated
        • Steward St. Elizabeth's Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • Recruiting
        • VA Ann Arbor
        • Principal Investigator:
          • Scott Hummel, MD, MS
      • Detroit, Michigan, United States, 48236
        • Terminated
        • Ascension St. John Hospital
    • 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 York
      • New York, New York, United States, 10016
        • Recruiting
        • New York University
        • Principal Investigator:
          • Tajinderpal Saraon, MD
      • New York, New York, United States, 10075
        • Active, not recruiting
        • Lenox Hill Hospital
      • New York, New York, United States, 10010
        • Terminated
        • VA NY Harbor Healthcare System
      • Roslyn, New York, United States, 11576
        • Terminated
        • St. Francis Hospital
      • Stony Brook, New York, United States, 11794-8167
        • Recruiting
        • Stony Brook Medicine
        • Principal Investigator:
          • Ahmad Alkhalil, 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:
          • Kishan Parikh, MD
      • 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:
          • Rishi Puri, MD
      • Toledo, Ohio, United States, 43606
        • Recruiting
        • ProMedica Toledo Hospital
        • Principal Investigator:
          • Kasi Ramanathan, MD
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73135
        • Recruiting
        • South Oklahoma Heart Research, LLC.
        • Principal Investigator:
          • Naeem Tahirkheli, MD
    • Oregon
      • Portland, Oregon, United States, 97225
        • Terminated
        • Providence St. Vincent's Medical Center
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17101
        • Recruiting
        • Pinnacle Health Cardiovascular Institute
        • Principal Investigator:
          • Roberto Hodara, MD
        • Principal Investigator:
          • Hemal Gada, MD
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Principal Investigator:
          • Sheldon Litwin, MD
      • Colombia, South Carolina, United States, 29203
        • Recruiting
        • Prisma Health - Midlands
        • Principal Investigator:
          • Vince Vismara, MD
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Recruiting
        • Monument Health
        • Principal Investigator:
          • K John Heilman III, MD
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Recruiting
        • Stern Cardiovascular Foundation
        • Principal Investigator:
          • Basil Paulus, MD
      • Knoxville, Tennessee, United States, 37934
        • Recruiting
        • Tennova Healthcare - Turkey Creek Medical Center
        • Principal Investigator:
          • Malcolm Foster, MD
    • 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
      • Dallas, Texas, United States, 75930
        • Recruiting
        • UT Southwestern
        • Principal Investigator:
          • Ambarish Pandey, MD
      • Plano, Texas, United States, 75093
        • Recruiting
        • Baylor Scott & White Research Institute
        • Principal Investigator:
          • Mollyu Szerlip, MD
      • Waco, Texas, United States, 76712
        • Recruiting
        • Waco Cardiology
        • Principal Investigator:
          • Donald Cross, MD
    • Washington
      • Seattle, Washington, United States, 98195
        • Active, not recruiting
        • University of Washington
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Active, not recruiting
        • 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)

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-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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