Recruiting

Alleviant ALV1Alleviant ALLAY-HFrEF Study

Sponsor:

Alleviant Medical, Inc.

Code:

NCT06812533

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Alleviant ALV1 System

Sham-Control

Study Details

Brief summary:

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.

Conditions

Heart Failure

Study ID

NCT06812533

Start date

Mar 10, 2025

Status verified date

Aug, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

350 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment

Subjects randomized to the treatment arm will undergo cardiac imaging, femoral vein access and receive the Alleviant ALV1 System device procedure.

sham comparator: Control

Subjects randomized to the control arm will undergo cardiac imaging and sheath placement in femoral vein.

Interventions

Alleviant ALV1 System

Creation of interatrial shunt

Sham-Control

Cardiac imaging

Primary outcome measure

Composite Primary Endpoint [ Time Frame: 12-Month ]

Central Contacts and Locations

Central contacts

Stacia Kraus

612-387-4552 stacia.kraus@alleviantmedical.com

Locations

Keck Medical Center of USC

Recruiting

Los Angeles, California, United States, 90033

Principal Investigator:

Michael Fong, MD

University California Los Angeles Medical Center

Recruiting

Los Angeles, California, United States, 90095

Principal Investigator:

Richard Cheng, MD

UC Davis Medical Center

Recruiting

Sacramento, California, United States, 95817

Principal Investigator:

Tai Pham, MD

Scripps Clinical Research Services

Recruiting

San Diego, California, United States, 92121

Principal Investigator:

Rajeev Mohan, MD

University of California San Francisco

Recruiting

San Francisco, California, United States, 94143

Principal Investigator:

Liviu Klein, MD

Delray Medical Center

Recruiting

Delray Beach, Florida, United States, 33484

Principal Investigator:

Philip Habib, MD

Ascension Sacred Heart

Recruiting

Pensacola, Florida, United States, 32504

Principal Investigator:

Rohit Amin, MD

Tampa General Hospital

Recruiting

Tampa, Florida, United States, 33606

Principal Investigator:

Jason Feliberti, MD

Atlanta VA Health Care System

Recruiting

Decatur, Georgia, United States, 30032

Principal Investigator:

Gautum Kumar, MD

Midwest Cardiovascular Institute

Recruiting

Naperville, Illinois, United States, 60540

Principal Investigator:

Stanislaw Skaluba, MD

Cardiovascular Institute of the South

Recruiting

Houma, Louisiana, United States, 70360

Principal Investigator:

Peter Fail, MD

University Medical Center New Orleans

Recruiting

New Orleans, Louisiana, United States, 70112

Principal Investigator:

Frank Smart, MD

Tufts Medical Center

Recruiting

Boston, Massachusetts, United States, 02111

Principal Investigator:

Jeong Hwan Kim, MD

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Principal Investigator:

Pinak Shah, MD

Boston Medical Center

Recruiting

Boston, Massachusetts, United States, 02118

Principal Investigator:

Nir Ayalon, MD

Minneapolis Heart Institute Foundation

Recruiting

Minneapolis, Minnesota, United States, 55407

Principal Investigator:

Peter Eckman, MD

Washington University - St Louis

Recruiting

St Louis, Missouri, United States, 63110

Principal Investigator:

Ali Javaheri, MD, PhD

UMC of Southern Nevada

Recruiting

Las Vegas, Nevada, United States, 89102

Principal Investigator:

Ahsan Chowdhury

Deborah Heart & Lung Center

Recruiting

Browns Mills, New Jersey, United States, 08015

Principal Investigator:

Geurys Rojas-Marte

Englewood Medical Center

Recruiting

Englewood, New Jersey, United States, 07631

Principal Investigator:

Ramin Hastings

Stony Brook Medicine

Recruiting

New York, New York, United States, 11794

Principal Investigator:

Ahmad Alkhalil, MD

Rochester General Hospital

Recruiting

Rochester, New York, United States, 14621

Principal Investigator:

Elizabeth Lee, MD

Mission Hospital

Recruiting

Asheville, North Carolina, United States, 28801

Principal Investigator:

Vinay Thohan, MD

Duke University Hospital

Recruiting

Durham, North Carolina, United States, 27705

Principal Investigator:

Robert Mentz, MD, FACC, FAHA, HFSA

NC Heart and Vascular Research

Recruiting

Raleigh, North Carolina, United States, 27607

Principal Investigator:

Elizabeth Volz, MD

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Principal Investigator:

J. Emanuel Finet, MD

ProMedica Toledo Hospital

Recruiting

Toledo, Ohio, United States, 43606

Principal Investigator:

P. Kasi Ramanathan, MD

Pinnacle Health Cardiovascular Institute

Recruiting

Harrisburg, Pennsylvania, United States, 17101

Principal Investigator:

Hemal Gada, MD

Roper St. Francis Healthcare

Recruiting

Charleston, South Carolina, United States, 29414

Principal Investigator:

Matthew O'Steen, MD

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Principal Investigator:

Brian Houston, MD

Monument Health

Recruiting

Rapid City, South Dakota, United States, 57701

Principal Investigator:

Luis Hernandez, MD

Tennova Healthcare - Turkey Creek Medical Center

Recruiting

Knoxville, Tennessee, United States, 37934

Principal Investigator:

Malcolm Foster

Hendrick Health

Recruiting

Abilene, Texas, United States, 79601

Principal Investigator:

Mark Lawrence, D.O.

Texas Cardiac Arrhythmia Research Foundation

Recruiting

Austin, Texas, United States, 78705

Principal Investigator:

Huseng Vefali, MD

Austin Heart

Recruiting

Austin, Texas, United States, 78756

Principal Investigator:

Kunjan Bhatt, MD

Baylor Scott & White Research Institute

Recruiting

Plano, Texas, United States, 75093

Principal Investigator:

Molly Szerlip

Baylor Scott & White - Temple

Recruiting

Temple, Texas, United States, 76508

Principal Investigator:

Ernesto Ruiz Duque, MD

Waco Cardiology

Recruiting

Waco, Texas, United States, 76712

Principal Investigator:

Donald Cross, MD

Carilion Clinic

Recruiting

Roanoke, Virginia, United States, 24014

Principal Investigator:

Daniel Pauly, MD

Southlake Regional Hospital Centre

Recruiting

Newmarket, Ontario, Canada, L3Y 2P6

Principal Investigator:

Liane Porepa, MD

Centre hospitalier de l'Universite de Montreal (CHUM)

Recruiting

Montreal, Quebec, Canada, H2X 0C1

Principal Investigator:

Brian Potter, MD

Centre Integre Universitaire de Sainte et de Services Scoiiaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CIUSSS de l'Estrie - CHUS)

Recruiting

Montreal, Quebec, Canada, H2X 0C1

Principal Investigator:

Benoit Daneault, MD

IUCPQ - Université Laval (Quebec)

Recruiting

Québec, Quebec, Canada, G1V 4G5

Principal Investigator:

Josep Rodés-Cabau, MD, PhD

More Information

Sponsor

Alleviant Medical, Inc.

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Alleviant Medical, Inc. on 2026-08-14.