Alleviant ALLAY-HFrEF Study
Recruiting · NCT06812533 · Interventional (participants receive a specific treatment) · Lead sponsor: Alleviant Medical, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
Alleviant ALV1 SystemSham-Control
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
60 locations listed across 19 US states.
- Keck Medical Center of USC - Los Angeles, California, United States
- University California Los Angeles Medical Center - 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
- Delray Medical Center - Delray Beach, Florida, United States
- Ascension Sacred Heart - Pensacola, Florida, United States
- Tampa General Hospital - Tampa, 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
- Minneapolis Heart Institute Foundation - Minneapolis, Minnesota, United States
- Washington University - St Louis - St Louis, Missouri, United States
- UMC of Southern Nevada - Las Vegas, Nevada, United States
- Deborah Heart & Lung Center - Browns Mills, New Jersey, United States
- Englewood Medical Center - Englewood, New Jersey, 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
- Roper St. Francis Healthcare - Charleston, South Carolina, 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
- Baylor Scott & White Research Institute - Plano, Texas, United States
- Baylor Scott & White - Temple - Temple, Texas, United States
- Waco Cardiology - Waco, Texas, United States
- Carilion Clinic - Roanoke, Virginia, United States
- Hospital Universitario A Coruna - A Coruña, Spain
- OLV Hospital - Aalst, Belgium
- ZAS Middelheim - Antwerp, Belgium
- Hippocration General Hospital Athens - Athens, Greece
- Hygeia Hospital - Athens, Greece
- Hospital de la Santa Creu i Sant Pau - Barcelona, Spain
- Hospital Clinic de Barcelona - Barcelona, Spain
- Vall d'Hebron University Hospital Barcelona - Barcelona, Spain
- AZ Sint Jan Brugge - Bruges, Belgium
- ChristChurch Hospital - Christchurch, New Zealand
- Dunedin Hospital - Dunedin, New Zealand
- Hospital Universitario 12 de Octubre - Madrid, Spain
- Hospital Universitario Puerta de Hierro - Madrid, Spain
- University Clinical Hospital in Opole - Opole, Poland
- Hospital Clínico Universitario de Salamanca - Salamanca, Spain
- Tbilisi Heart and Vascular - Tbilisi, Georgia
- Tel Aviv Sourasky Medical Center - Tel Aviv, Israel
- European Interbalken Medical Center - Thessaloniki, Greece
- Valencia Hospital Clinico - Valencia, Spain
- Narodowy Instytut Kardiologii im. Stefana kardynała Wyszyńsk - Warsaw, Poland
- Uniwesytecki Szpital Kliniczny - Wroclaw, Poland
Showing 60 of 67 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →