NCT06812533Recruiting
Alleviant ALLAY-HFrEF Study
Safety and Efficacy of the Alleviant No-Implant Interatrial Shunt in Patients With Heart Failure and Reduced Ejection Fraction
Source: ClinicalTrials.gov · Last updated 6 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 350 (estimated)
- First submitted
- 3 Feb 2025
- Start date
- 10 Mar 2025
- Primary completion date
- Dec 2028
- Lead sponsor
- Alleviant Medical, Inc.
- Diseases
- Heart failure
- NCT number
- NCT06812533
What you commit to
- Study type: Interventional
- Planned participants: 350
- From 10 Mar 2025 to the primary completion date, Dec 2028
- 70 sites in 11 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Advanced heart failure
- Evidence of right heart dysfunction
Other
- Life-expectancy \< 12 months
Who the study is looking for
- LVEF ≤ 40%
- NYHA class II, III or ambulatory IV HF
- Receiving optimal, maximally tolerated, stable GDMT
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (70)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Monash Health Victorian Heart Hospital Coordinator of this site? Confirm its status | Clayton | Australia | Recruiting |
| Alfred Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| OLV Hospital Coordinator of this site? Confirm its status | Aalst | Belgium | Recruiting |
| ZAS Middelheim Coordinator of this site? Confirm its status | Antwerp | Belgium | Recruiting |
| Az Sint Jan Brugge Coordinator of this site? Confirm its status | Bruges | Belgium | Recruiting |
| Centre Integre Universitaire de Sainte et de Services Scoiiaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CIUSSS de l'Estrie - CHUS) Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| Centre Hospitalier de l'Universite de Montreal (CHUM) Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| Southlake Regional Hospital Centre Coordinator of this site? Confirm its status | Newmarket | Canada | Recruiting |
| IUCPQ - Université Laval (Quebec) Coordinator of this site? Confirm its status | Québec | Canada | Recruiting |
| Hospital Universitario A Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Recruiting |
| Vall d'Hebron University Hospital Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Terminated |
| Hospital Universitario Puerta de Hierro Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Clinico Universitario de Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Recruiting |
| Valencia Hospital Clinico Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Tbilisi Heart and Vascular Coordinator of this site? Confirm its status | Tbilisi | Georgia | Recruiting |
| Hippocration General Hospital Athens Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| HYGEIA Hospital Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| European Interbalken Medical Center Coordinator of this site? Confirm its status | Thessaloniki | Greece | Recruiting |
| Tel-Aviv Sourasky Medical Center Coordinator of this site? Confirm its status | Tel Aviv | Israel | Recruiting |
| Shamir Medical Center Coordinator of this site? Confirm its status | Zrifin | Israel | Recruiting |
| Christchurch Hospital Coordinator of this site? Confirm its status | Christchurch | New Zealand | Recruiting |
| Dunedin Hospital Coordinator of this site? Confirm its status | Dunedin | New Zealand | Recruiting |
| University Clinical Hospital in Opole Coordinator of this site? Confirm its status | Opole | Poland | Recruiting |
| Narodowy Instytut Kardiologii im. Stefana kardynała Wyszyńsk Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Uniwesytecki Szpital Kliniczny Coordinator of this site? Confirm its status | Wroclaw | Poland | Recruiting |
| National Institute for Heart and Blood Vessels Dedinje Coordinator of this site? Confirm its status | Belgrade | Serbia | Recruiting |
| University Clinical Centre of Kragujevac Coordinator of this site? Confirm its status | Kragujevac | Serbia | Recruiting |
| Hendrick Health Coordinator of this site? Confirm its status | Abilene | United States | Recruiting |
| Mission Hospital Coordinator of this site? Confirm its status | Asheville | United States | Recruiting |
| Texas Cardiac Arrhythmia Research Foundation Coordinator of this site? Confirm its status | Austin | United States | Terminated |
| Austin Heart Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Tufts Medical Center Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Boston Medical Center Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Deborah Heart & Lung Center Coordinator of this site? Confirm its status | Browns Mills | United States | Recruiting |
| Roper St. Francis Healthcare Coordinator of this site? Confirm its status | Charleston | United States | Recruiting |
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Recruiting |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| Atlanta VA Health Care System Coordinator of this site? Confirm its status | Decatur | United States | Recruiting |
| Delray Medical Center Coordinator of this site? Confirm its status | Delray Beach | United States | Recruiting |
| Duke University Hospital Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
| Englewood Medical Center Coordinator of this site? Confirm its status | Englewood | United States | Recruiting |
| Pinnacle Health Cardiovascular Institute Coordinator of this site? Confirm its status | Harrisburg | United States | Recruiting |
| Cardiovascular Institute of the South Coordinator of this site? Confirm its status | Houma | United States | Recruiting |
| Tennova Healthcare-Turkey Creek Medical Center Coordinator of this site? Confirm its status | Knoxville | United States | Recruiting |
| UMC of Southern Nevada Coordinator of this site? Confirm its status | Las Vegas | United States | Recruiting |
| Keck Medical Center of USC Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| University California Los Angeles Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Minneapolis Heart Institute Foundation Coordinator of this site? Confirm its status | Minneapolis | United States | Recruiting |
| Midwest Cardiovascular Institute Coordinator of this site? Confirm its status | Naperville | United States | Recruiting |
| University Medical Center New Orleans Coordinator of this site? Confirm its status | New Orleans | United States | Recruiting |
| Stony Brook Medicine Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Ascension Sacred Heart Coordinator of this site? Confirm its status | Pensacola | United States | Recruiting |
| Baylor Scott & White Research Institute Coordinator of this site? Confirm its status | Plano | United States | Recruiting |
| NC Heart and Vascular Research Coordinator of this site? Confirm its status | Raleigh | United States | Recruiting |
| Monument Health Coordinator of this site? Confirm its status | Rapid City | United States | Recruiting |
| Carilion Clinic Coordinator of this site? Confirm its status | Roanoke | United States | Recruiting |
| University of Rochester Medical Center Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| Rochester General Hospital Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| UC Davis Medical Center Coordinator of this site? Confirm its status | Sacramento | United States | Recruiting |
| Scripps Clinical Research Services Coordinator of this site? Confirm its status | San Diego | United States | Recruiting |
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
| Washington University St. Louis Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| Tampa General Hospital Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
| Baylor Scott & White - Temple Coordinator of this site? Confirm its status | Temple | United States | Recruiting |
| ProMedica Toledo Hospital Coordinator of this site? Confirm its status | Toledo | United States | Recruiting |
| Waco Cardiology Coordinator of this site? Confirm its status | Waco | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.