Alleviant ALLAY-HFrEF Study

NCT06812533 | Enrolling By Invitation FDA Device

• 1 other identifier: CIP-0006
• Study Type: interventional
• Target: 350
• Locations: 10 countries
• Sites: 58

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

Outcome Measures

Primary Outcomes (1)

• Composite Primary Endpoint

  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

Study Arms (2)

Treatment

EXPERIMENTAL

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

Control

SHAM COMPARATOR

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

Other: Sham-Control

Interventions

Alleviant ALV1 System DEVICE

Creation of interatrial shunt

Treatment

Sham-Control OTHER

Cardiac imaging

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• LVEF ≤ 40%
• NYHA class II, III or ambulatory IV HF
• Receiving optimal, maximally tolerated, stable GDMT

You may not qualify if:

• Advanced heart failure
• Life-expectancy \< 12 months
• Evidence of right heart dysfunction

Sponsors & Collaborators

• Alleviant Medical, Inc.: lead

Study Sites (58)

Keck Medical Center of USC

Los Angeles, California, 90033, United States

Location

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

Scripps Clinical Research Services

San Diego, California, 92121, United States

Location

University of California San Francisco

San Francisco, California, 94143, United States

Location

Ascension Sacred Heart

Pensacola, Florida, 32504, United States

Location

Atlanta VA Health Care System

Decatur, Georgia, 30032, United States

Location

Midwest Cardiovascular Institute

Naperville, Illinois, 60540, United States

Location

Cardiovascular Institute of the South

Houma, Louisiana, 70360, United States

Location

University Medical Center New Orleans

New Orleans, Louisiana, 70112, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

Location

Washington University - St Louis

St Louis, Missouri, 63110, United States

Location

Stony Brook Medicine

New York, New York, 11794, United States

Location

Rochester General Hospital

Rochester, New York, 14621, United States

Location

Mission Hospital

Asheville, North Carolina, 28801, United States

Location

Duke University Hospital

Durham, North Carolina, 27705, United States

Location

NC Heart and Vascular Research

Raleigh, North Carolina, 27607, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

ProMedica Toledo Hospital

Toledo, Ohio, 43606, United States

Location

Pinnacle Health Cardiovascular Institute

Harrisburg, Pennsylvania, 17101, United States

Location

Roper St. Francis Healthcare

Charleston, South Carolina, 29414, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Monument Health

Rapid City, South Dakota, 57701, United States

Location

Tennova Healthcare - Turkey Creek Medical Center

Knoxville, Tennessee, 37934, United States

Location

Hendrick Health

Abilene, Texas, 79601, United States

Location

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, 78705, United States

Location

Austin Heart

Austin, Texas, 78756, United States

Location

Baylor Scott & White Research Institute

Plano, Texas, 75093, United States

Location

NextStage Clinical Research

Waco, Texas, 76712, United States

Location

Carilion Clinic

Roanoke, Virginia, 24014, United States

Location

Monash Health Victorian Heart Hospital

Clayton, Victoria, 3068, Australia

Location

Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

OLV Hospital

Aalst, Belgium

Location

ZAS Middelheim

Antwerp, Belgium

Location

AZ Sint Jan Brugge

Bruges, Belgium

Location

Southlake Regional Hospital Centre

Newmarket, Ontario, L3Y 2P6, Canada

Location

Centre hospitalier de l'Universite de Montreal (CHUM)

Montreal, Quebec, H2X 0C1, Canada

Location

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

Montreal, Quebec, H2X 0C1, Canada

Location

IUCPQ - Université Laval (Quebec)

Québec, G1V 4G5, Canada

Location

Tbilisi Heart and Vascular

Tbilisi, Georgia

Location

Hygeia Hospital

Athens, 15123, Greece

Location

European Interbalken Medical Center

Thessaloniki, Greece

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

Shamir Medical Center

Zrifin, Israel

Location

ChristChurch Hospital

Christchurch, 8011, New Zealand

Location

Dunedin Hospital

Dunedin, 9016, New Zealand

Location

University Clinical Hospital in Opole

Opole, Poland

Location

Narodowy Instytut Kardiologii im. Stefana kardynała Wyszyńsk

Warsaw, Poland

Location

Uniwesytecki Szpital Kliniczny

Wroclaw, Poland

Location

Hospital Universitario A Coruna

A Coruña, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

Vall d'Hebron University Hospital Barcelona

Barcelona, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario Puerta de Hierro

Madrid, 28222, Spain

Location

Hospital Clínico Universitario de Salamanca

Salamanca, Spain

Location

Valencia Hospital Clinico

Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Gregg Stone

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• James Udelson

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 6, 2025
• Study Start: March 10, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (32); BE (3); PL (3); ES (7); CA (4); GE (1); GR (2); AU (2); NZ (2); IL (2)