Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
350 participants
INTERVENTIONAL
2025-03-10
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Treatment
Subjects randomized to the treatment arm will undergo cardiac imaging, femoral vein access and receive the Alleviant ALV1 System device procedure.
Alleviant ALV1 System
Creation of interatrial shunt
Control
Subjects randomized to the control arm will undergo cardiac imaging and sheath placement in femoral vein.
Sham-Control
Cardiac imaging
Interventions
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Alleviant ALV1 System
Creation of interatrial shunt
Sham-Control
Cardiac imaging
Eligibility Criteria
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Inclusion Criteria
* NYHA class II, III or ambulatory IV HF
* Receiving optimal, maximally tolerated, stable GDMT
Exclusion Criteria
* Life-expectancy \< 12 months
* Evidence of right heart dysfunction
18 Years
ALL
No
Sponsors
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Alleviant Medical, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Gregg Stone
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
James Udelson
Role: PRINCIPAL_INVESTIGATOR
Tufts Medical Center
Locations
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Keck Medical Center of USC
Los Angeles, California, United States
UC Davis Medical Center
Sacramento, California, United States
Scripps Clinical Research Services
San Diego, California, United States
University of California San Francisco
San Francisco, California, United States
Ascension Sacred Heart
Pensacola, Florida, United States
Atlanta VA Health Care System
Decatur, Georgia, United States
Midwest Cardiovascular Institute
Naperville, Illinois, United States
Cardiovascular Institute of the South
Houma, Louisiana, United States
University Medical Center New Orleans
New Orleans, Louisiana, United States
Tufts Medical Center
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Boston Medical Center
Boston, Massachusetts, United States
Washington University - St Louis
St Louis, Missouri, United States
Stony Brook Medicine
New York, New York, United States
Rochester General Hospital
Rochester, New York, United States
Mission Hospital
Asheville, North Carolina, United States
Duke University Hospital
Durham, North Carolina, United States
NC Heart and Vascular Research
Raleigh, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
ProMedica Toledo Hospital
Toledo, Ohio, United States
Pinnacle Health Cardiovascular Institute
Harrisburg, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Monument Health
Rapid City, South Dakota, United States
Tennova Healthcare - Turkey Creek Medical Center
Knoxville, Tennessee, United States
Hendrick Health
Abilene, Texas, United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States
Austin Heart
Austin, Texas, United States
NextStage Clinical Research
Waco, Texas, United States
Carilion Clinic
Roanoke, Virginia, United States
OLV Hospital
Aalst, , Belgium
AZ Sint Jan Brugge
Bruges, , Belgium
Southlake Regional Hospital Centre
Newmarket, Ontario, Canada
Centre hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, 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, Canada
IUCPQ - Université Laval (Quebec)
Québec, , Canada
Tbilisi Heart and Vascular
Tbilisi, , Georgia
Uniwesytecki Szpital Kliniczny
Wroclaw, , Poland
Hospital Universitario A Coruna
A Coruña, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Vall d'Hebron University Hospital Barcelona
Barcelona, , Spain
Hospital Universitario Puerta de Hierro
Madrid, , Spain
Hospital Clínico Universitario de Salamanca
Salamanca, , Spain
Valencia Hospital Clinico
Valencia, , Spain
Countries
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Other Identifiers
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CIP-0006
Identifier Type: -
Identifier Source: org_study_id