Alleviant ALLAY-HF Study
Safety and Efficacy of the Alleviant System for No-Implant Interatrial Shunt Creation in Patients With Chronic Heart Failure
1 other identifier
interventional
700
14 countries
95
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable heart-failure
Started Jan 2023
Longer than P75 for not_applicable heart-failure
95 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 14, 2022
CompletedStudy Start
First participant enrolled
January 10, 2023
CompletedFirst Posted
Study publicly available on registry
January 17, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2032
May 4, 2026
April 1, 2026
4.9 years
December 14, 2022
April 30, 2026
Conditions
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
EXPERIMENTALSubjects randomized to the treatment arm will undergo cardiac imaging, femoral vein access and receive the Alleviant ALV1 System device procedure.
Control
SHAM COMPARATORSubjects randomized to the control arm will undergo cardiac imaging and sheath placement in femoral vein.
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (97)
University of Alabama
Birmingham, Alabama, 35249, United States
Arizona Cardiovascular Research Center
Phoenix, Arizona, 85016, United States
Pima Heart and Vascular
Tucson, Arizona, 85718, United States
Memorial Care Long Beach Medical Center
Long Beach, California, 90806, United States
UC Davis Medical Center
Sacramento, California, 95817, United States
Scripps Clinical Research Services
San Diego, California, 92121, United States
San Francisco VA
San Francisco, California, 94121, United States
University of California San Francisco
San Francisco, California, 94143, United States
Santa Barbara Cottage Hospital
Santa Barbara, California, 93105, United States
Hartford Hospital
Hartford, Connecticut, 06106, United States
The Cardiac and Vascular Institute (TCAVI)
Gainesville, Florida, 32504, United States
HCA Florida Memorial Hospital
Jacksonville, Florida, 32216, United States
NCH Research Institute
Naples, Florida, 34102, United States
Advent Health Orlando
Orlando, Florida, 32803, United States
Ascension Sacred Heart
Pensacola, Florida, 32504, United States
Atlanta VA Health Care System
Decatur, Georgia, 30032, United States
Advocate Illinois Masonic Medical Center
Chicago, Illinois, 60657, United States
Midwest Cardiovascular Institute
Naperville, Illinois, 60540, United States
Prairie Education and Research Cooperative
Springfield, Illinois, 62769, United States
Indiana University
Indianapolis, Indiana, 46202, United States
St. Elizabeth Healthcare
Edgewood, Kentucky, 41017, United States
Cardiovascular Institute of the South
Houma, Louisiana, 70360, United States
University Medical Center New Orleans
New Orleans, Louisiana, 70112, United States
Johns Hopkins Medical Institution
Baltimore, Maryland, 21287, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
VA Ann Arbor
Ann Arbor, Michigan, 48105, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407, United States
Washington University - St Louis
St Louis, Missouri, 63110, United States
VA NY Harbor Healthcare System
New York, New York, 10010, United States
New York University
New York, New York, 10016, United States
Lenox Hill Hospital
New York, New York, 10075, United States
St. Francis Hospital
Roslyn, New York, 11576, United States
Stony Brook Medicine
Stony Brook, New York, 11794-8167, United States
Mission Hospital
Asheville, North Carolina, 28801, United States
Duke University Hospital
Durham, North Carolina, 27705, United States
NC Heart and Vascular Research
Raleigh, North Carolina, 27607, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
ProMedica Toledo Hospital
Toledo, Ohio, 43606, United States
South Oklahoma Heart Research, LLC.
Oklahoma City, Oklahoma, 73135, United States
Providence St. Vincent's Medical Center
Portland, Oregon, 97225, United States
Pinnacle Health Cardiovascular Institute
Harrisburg, Pennsylvania, 17101, United States
Prisma Health - Midlands
Columbia, South Carolina, 29203, United States
Monument Health
Rapid City, South Dakota, 57701, United States
Stern Cardiovascular Foundation
Germantown, Tennessee, 38138, United States
Tennova Healthcare - Turkey Creek Medical Center
Knoxville, Tennessee, 37934, United States
Hendrick Health
Abilene, Texas, 79601, United States
Austin Heart
Austin, Texas, 78756, United States
UT Southwestern
Dallas, Texas, 75930, United States
Baylor Scott & White Research Institute
Plano, Texas, 75093, United States
NextStage Clinical Research
Waco, Texas, 76712, United States
University of Washington
Seattle, Washington, 98195, United States
Advocate Aurora Health/Aurora Research Institute
Milwaukee, Wisconsin, 53215, United States
Monash Health Victorian Heart Hospital
Clayton, Victoria, 3068, Australia
Austin Hospital
Heidelberg, Victoria, 3084, Australia
Medizinische Universität Graz
Graz, Austria
OLV Hospital
Aalst, Belgium
ZAS Middelheim
Antwerp, Belgium
AZ Sint Jan Brugge
Bruges, Belgium
University Hospital UMHAT Sveti Georgi
Plovdiv, 4002, Bulgaria
Acibadem City Clinic University Tokuda Hospital
Sofia, 1407, Bulgaria
Acibadem City Clinic Cardiovascular Center Sofia
Sofia, 1700, Bulgaria
Southlake Regional Hospital Centre
Newmarket, Ontario, L3Y 2P6, Canada
Centre hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, H2X 0C1, Canada
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
Kardiocentrum Nemocnice AGEL Trinec-Podlesi
Třinec, 73961, Czechia
Tbilisi Heart and Vascular
Tbilisi, Georgia
Heart and Vascular Center-Bad Bevensen
Bad Bevensen, 29549, Germany
Herz- und Gefasszentrum Bad Bevensen
Bad Bevensen, 29549, Germany
University of Gießen
Giessen, 35392, Germany
Marienkrankenhaus
Hamburg, 22087, Germany
Askelepios Klinik Altona
Hamburg, 22763, Germany
St. Vincentius Kliniken
Karlsruhe, 76137, Germany
Universitatsklinikum Schleswig-Holstein (UKSH)
Lübeck, 23538, Germany
Universitätsklinikum Kardiologie
Magdeburg, 39120, Germany
Universitatsmedizin Rostock
Rostock, 18057, Germany
European Interbalken Medical Center
Thessaloniki, Greece
Shaare Zedek Medical Center
Jerusalem, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Shamir Medical Center
Zrifin, Israel
Humanitas Research Milan
Rozzano, MI, Italy
Instituto Auxologico Italiano
Milan, 20149, Italy
ChristChurch Hospital
Christchurch, 8011, New Zealand
Dunedin Hospital
Dunedin, 9016, New Zealand
University Clinical Hospital in Opole
Opole, Poland
Poznan University of Medical Sciences
Poznan, Poland
Kashubian Center for Heart and Vascular Diseases, Pomeranian
Wejherowo, 84-200, Poland
4th Military Hospital
Wroclaw, Poland
Uniwesytecki Szpital Kliniczny
Wroclaw, Poland
Silesian Center for Heart Disease
Zabrze, Poland
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025, Spain
Barcelona Hospital del Mar
Barcelona, 08033, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Vall d'Hebron University Hospital Barcelona
Barcelona, Spain
Hospital Universitario Puerta de Hierro
Madrid, 28222, Spain
Hospital Clínico Universitario de Salamanca
Salamanca, Spain
Valencia Hospital Clinico
Valencia, 46010, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James Udelson, MD
Tufts Medical Center
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
May 4, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share