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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.
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

Full criteria on ClinicalTrials.gov

Sites (70)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Monash Health Victorian Heart Hospital
Coordinator of this site? Confirm its status
ClaytonAustraliaRecruiting
Alfred Hospital
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MelbourneAustraliaRecruiting
OLV Hospital
Coordinator of this site? Confirm its status
AalstBelgiumRecruiting
ZAS Middelheim
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AntwerpBelgiumRecruiting
Az Sint Jan Brugge
Coordinator of this site? Confirm its status
BrugesBelgiumRecruiting
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
MontrealCanadaRecruiting
Centre Hospitalier de l'Universite de Montreal (CHUM)
Coordinator of this site? Confirm its status
MontrealCanadaRecruiting
Southlake Regional Hospital Centre
Coordinator of this site? Confirm its status
NewmarketCanadaRecruiting
IUCPQ - Université Laval (Quebec)
Coordinator of this site? Confirm its status
QuébecCanadaRecruiting
Hospital Universitario A Coruña
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A CoruñaSpainRecruiting
Vall d'Hebron University Hospital Barcelona
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BarcelonaSpainRecruiting
Hospital Clinic de Barcelona
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BarcelonaSpainRecruiting
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainRecruiting
Hospital Universitario 12 de Octubre
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MadridSpainTerminated
Hospital Universitario Puerta de Hierro
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MadridSpainRecruiting
Hospital Clinico Universitario de Salamanca
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SalamancaSpainRecruiting
Valencia Hospital Clinico
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ValenciaSpainRecruiting
Tbilisi Heart and Vascular
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TbilisiGeorgiaRecruiting
Hippocration General Hospital Athens
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AthensGreeceRecruiting
HYGEIA Hospital
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AthensGreeceRecruiting
European Interbalken Medical Center
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ThessalonikiGreeceRecruiting
Tel-Aviv Sourasky Medical Center
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Tel AvivIsraelRecruiting
Shamir Medical Center
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ZrifinIsraelRecruiting
Christchurch Hospital
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ChristchurchNew ZealandRecruiting
Dunedin Hospital
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DunedinNew ZealandRecruiting
University Clinical Hospital in Opole
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OpolePolandRecruiting
Narodowy Instytut Kardiologii im. Stefana kardynała Wyszyńsk
Coordinator of this site? Confirm its status
WarsawPolandRecruiting
Uniwesytecki Szpital Kliniczny
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WroclawPolandRecruiting
National Institute for Heart and Blood Vessels Dedinje
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BelgradeSerbiaRecruiting
University Clinical Centre of Kragujevac
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KragujevacSerbiaRecruiting
Hendrick Health
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AbileneUnited StatesRecruiting
Mission Hospital
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AshevilleUnited StatesRecruiting
Texas Cardiac Arrhythmia Research Foundation
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AustinUnited StatesTerminated
Austin Heart
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AustinUnited StatesRecruiting
Brigham and Women's Hospital
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BostonUnited StatesRecruiting
Tufts Medical Center
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BostonUnited StatesRecruiting
Boston Medical Center
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BostonUnited StatesRecruiting
Deborah Heart & Lung Center
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Browns MillsUnited StatesRecruiting
Roper St. Francis Healthcare
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CharlestonUnited StatesRecruiting
Medical University of South Carolina
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CharlestonUnited StatesRecruiting
Cleveland Clinic
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ClevelandUnited StatesRecruiting
Atlanta VA Health Care System
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DecaturUnited StatesRecruiting
Delray Medical Center
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Delray BeachUnited StatesRecruiting
Duke University Hospital
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DurhamUnited StatesRecruiting
Englewood Medical Center
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EnglewoodUnited StatesRecruiting
Pinnacle Health Cardiovascular Institute
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HarrisburgUnited StatesRecruiting
Cardiovascular Institute of the South
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HoumaUnited StatesRecruiting
Tennova Healthcare-Turkey Creek Medical Center
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KnoxvilleUnited StatesRecruiting
UMC of Southern Nevada
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Las VegasUnited StatesRecruiting
Keck Medical Center of USC
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Los AngelesUnited StatesRecruiting
University California Los Angeles Medical Center
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Los AngelesUnited StatesRecruiting
Minneapolis Heart Institute Foundation
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MinneapolisUnited StatesRecruiting
Midwest Cardiovascular Institute
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NapervilleUnited StatesRecruiting
University Medical Center New Orleans
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New OrleansUnited StatesRecruiting
Stony Brook Medicine
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New YorkUnited StatesRecruiting
Ascension Sacred Heart
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PensacolaUnited StatesRecruiting
Baylor Scott & White Research Institute
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PlanoUnited StatesRecruiting
NC Heart and Vascular Research
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RaleighUnited StatesRecruiting
Monument Health
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Rapid CityUnited StatesRecruiting
Carilion Clinic
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RoanokeUnited StatesRecruiting
University of Rochester Medical Center
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RochesterUnited StatesRecruiting
Rochester General Hospital
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RochesterUnited StatesRecruiting
UC Davis Medical Center
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SacramentoUnited StatesRecruiting
Scripps Clinical Research Services
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San DiegoUnited StatesRecruiting
University of California San Francisco
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San FranciscoUnited StatesRecruiting
Washington University St. Louis
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St LouisUnited StatesRecruiting
Tampa General Hospital
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TampaUnited StatesRecruiting
Baylor Scott & White - Temple
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TempleUnited StatesRecruiting
ProMedica Toledo Hospital
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ToledoUnited StatesRecruiting
Waco Cardiology
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WacoUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.