Alleviant ALLAY-HF Study

NCT05685303 | Recruiting FDA Device

• 1 other identifier: CIP-0003
• Study Type: interventional
• Target: 700
• Locations: 13 countries
• Sites: 92

Brief Summary

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Composite Primary Endpoint

  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

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

You may qualify if:

• Symptomatic HFpEF/HFmrEF with LVEF greater than or equal to 40%
• NYHA Class II, III or ambulatory IV
• Exercise right heart catheterization\*
• Elevated left atrial pressure during exercise right heart catheterization (greater than or equal to 25 mmHg)
• Exercise PVR \< 1.8 WU
• Ongoing stable GDMT

You may not qualify if:

• Advanced heart failure
• Presence of a pacemaker
• Evidence of right heart dysfunction

Sponsors & Collaborators

• Alleviant Medical, Inc.: lead

Study Sites (93)

Arizona Cardiovascular Research Center

Phoenix, Arizona, 85016, United States

ACTIVE NOT RECRUITING

HonorHealth

Scottsdale, Arizona, 85258, United States

TERMINATED

Pima Heart and Vascular

Tucson, Arizona, 85718, United States

RECRUITING

Memorial Care Long Beach Medical Center

Long Beach, California, 90806, United States

RECRUITING

UC Davis Medical Center

Sacramento, California, 95817, United States

RECRUITING

Scripps Clinical Research Services

San Diego, California, 92121, United States

RECRUITING

University of California San Francisco

San Francisco, California, 94143, United States

RECRUITING

Santa Barbara Cottage Hospital

Santa Barbara, California, 93105, United States

RECRUITING

Hartford Hospital

Hartford, Connecticut, 06106, United States

TERMINATED

The Cardiac and Vascular Institute (TCAVI)

Gainesville, Florida, 32504, United States

RECRUITING

HCA Florida Memorial Hospital

Jacksonville, Florida, 32216, United States

RECRUITING

NCH Research Institute

Naples, Florida, 34102, United States

RECRUITING

Advent Health Orlando

Orlando, Florida, 32803, United States

RECRUITING

Ascension Sacred Heart

Pensacola, Florida, 32504, United States

RECRUITING

Atlanta VA Health Care System

Decatur, Georgia, 30032, United States

RECRUITING

Advocate Illinois Masonic Medical Center

Chicago, Illinois, 60657, United States

TERMINATED

Midwest Cardiovascular Institute

Naperville, Illinois, 60540, United States

RECRUITING

Prairie Education and Research Cooperative

Springfield, Illinois, 62769, United States

ACTIVE NOT RECRUITING

Indiana University

Indianapolis, Indiana, 46202, United States

RECRUITING

St. Elizabeth Healthcare

Edgewood, Kentucky, 41017, United States

RECRUITING

Cardiovascular Institute of the South

Houma, Louisiana, 70360, United States

RECRUITING

University Medical Center New Orleans

New Orleans, Louisiana, 70112, United States

RECRUITING

Johns Hopkins Medical Institution

Baltimore, Maryland, 21287, United States

RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Boston Medical Center

Boston, Massachusetts, 02118, United States

RECRUITING

Steward St. Elizabeth's Medical Center

Brighton, Massachusetts, 02135, United States

TERMINATED

VA Ann Arbor

Ann Arbor, Michigan, 48105, United States

RECRUITING

Ascension St. John Hospital

Detroit, Michigan, 48236, United States

TERMINATED

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

RECRUITING

Washington University - St Louis

St Louis, Missouri, 63110, United States

RECRUITING

UMC of Southern Nevada

Las Vegas, Nevada, 89102, United States

RECRUITING

VA NY Harbor Healthcare System

New York, New York, 10010, United States

TERMINATED

New York University

New York, New York, 10016, United States

RECRUITING

Lenox Hill Hospital

New York, New York, 10075, United States

ACTIVE NOT RECRUITING

St. Francis Hospital

Roslyn, New York, 11576, United States

TERMINATED

Stony Brook Medicine

Stony Brook, New York, 11794-8167, United States

RECRUITING

Mission Hospital

Asheville, North Carolina, 28801, United States

RECRUITING

Duke University Hospital

Durham, North Carolina, 27705, United States

RECRUITING

NC Heart and Vascular Research

Raleigh, North Carolina, 27607, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

ProMedica Toledo Hospital

Toledo, Ohio, 43606, United States

RECRUITING

South Oklahoma Heart Research, LLC.

Oklahoma City, Oklahoma, 73135, United States

RECRUITING

Providence St. Vincent's Medical Center

Portland, Oregon, 97225, United States

TERMINATED

Pinnacle Health Cardiovascular Institute

Harrisburg, Pennsylvania, 17101, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Prisma Health - Midlands

Colombia, South Carolina, 29203, United States

RECRUITING

Monument Health

Rapid City, South Dakota, 57701, United States

RECRUITING

Stern Cardiovascular Foundation

Germantown, Tennessee, 38138, United States

RECRUITING

Tennova Healthcare - Turkey Creek Medical Center

Knoxville, Tennessee, 37934, United States

RECRUITING

Hendrick Health

Abilene, Texas, 79601, United States

RECRUITING

Austin Heart

Austin, Texas, 78756, United States

RECRUITING

UT Southwestern

Dallas, Texas, 75930, United States

RECRUITING

Baylor Scott & White Research Institute

Plano, Texas, 75093, United States

RECRUITING

Waco Cardiology

Waco, Texas, 76712, United States

RECRUITING

University of Washington

Seattle, Washington, 98195, United States

ACTIVE NOT RECRUITING

Advocate Aurora Health/Aurora Research Institute

Milwaukee, Wisconsin, 53215, United States

ACTIVE NOT RECRUITING

Monash Health Victorian Heart Hospital

Clayton, Victoria, 3068, Australia

RECRUITING

Austin Hospital

Heidelberg, Victoria, 3084, Australia

RECRUITING

Medizinische Universität Graz

Graz, Austria

RECRUITING

OLV Hospital

Aalst, Belgium

RECRUITING

ZAS Middelheim

Antwerp, Belgium

RECRUITING

AZ Sint Jan Brugge

Bruges, Belgium

RECRUITING

University Hospital UMHAT Sveti Georgi

Plovdiv, 4002, Bulgaria

RECRUITING

Southlake Regional Hospital Centre

Newmarket, Ontario, L3Y 2P6, Canada

RECRUITING

Centre hospitalier de l'Universite de Montreal (CHUM)

Montreal, Quebec, H2X 0C1, Canada

RECRUITING

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

RECRUITING

Kardiocentrum Nemocnice AGEL Trinec-Podlesi

Třinec, 73961, Czechia

RECRUITING

Tbilisi Heart and Vascular

Tbilisi, Georgia

RECRUITING

Marienkrankenhaus

Hamburg, 22087, Germany

TERMINATED

Universitatsklinikum Schleswig-Holstein (UKSH)

Lübeck, 23538, Germany

RECRUITING

Universitätsklinikum Kardiologie

Magdeburg, 39120, Germany

RECRUITING

Shaare Zedek Medical Center

Jerusalem, Israel

TERMINATED

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

RECRUITING

Shamir Medical Center

Zrifin, Israel

RECRUITING

Humanitas Research Milan

Rozzano, Michigan, Italy

TERMINATED

Instituto Auxologico Italiano

Milan, 20149, Italy

RECRUITING

ChristChurch Hospital

Christchurch, 8011, New Zealand

RECRUITING

Dunedin Hospital

Dunedin, 9016, New Zealand

RECRUITING

University Clinical Hospital in Opole

Opole, Poland

RECRUITING

Poznan University of Medical Sciences

Poznan, Poland

RECRUITING

Kashubian Center for Heart and Vascular Diseases, Pomeranian

Wejherowo, 84-200, Poland

RECRUITING

4th Military Hospital

Wroclaw, Poland

RECRUITING

Uniwesytecki Szpital Kliniczny

Wroclaw, Poland

RECRUITING

Silesian Center for Heart Disease

Zabrze, Poland

RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

RECRUITING

Barcelona Hospital del Mar

Barcelona, 08033, Spain

RECRUITING

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

RECRUITING

Germans Trias i Pujol University Hospital

Barcelona, 08916, Spain

TERMINATED

Vall d'Hebron University Hospital Barcelona

Barcelona, Spain

RECRUITING

Hospital Universitario Puerta del Cadíz

Cadiz, 11009, Spain

TERMINATED

Hospital Universitario Puerta de Hierro

Madrid, 28222, Spain

RECRUITING

Hospital Clínico Universitario de Salamanca

Salamanca, Spain

RECRUITING

Valencia Hospital Clinico

Valencia, 46010, Spain

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• James Udelson, MD

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Olson

CONTACT

+1 612 327 2741; jen.olson@alleviantmedical.com

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: December 14, 2022
• First Posted: January 17, 2023
• Study Start: January 10, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2032
• Last Updated: August 14, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2); CZ (1); BU (1); GE (1); US (56); DE (3); IL (3); NZ (2); CA (3); PL (6); ES (9); BE (3); AU (2)