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NCT05685303Recruiting

Alleviant ALLAY-HF Study

Safety and Efficacy of the Alleviant System for No-Implant Interatrial Shunt Creation in Patients With Chronic Heart Failure

Source: ClinicalTrials.gov · Last updated 14 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
700 (estimated)
First submitted
14 Dec 2022
Start date
10 Jan 2023
Primary completion date
1 Dec 2027
Lead sponsor
Alleviant Medical, Inc.
NCT number
NCT05685303

What you commit to

  • Study type: Interventional
  • Planned participants: 700
  • From 10 Jan 2023 to the primary completion date, 1 Dec 2027
  • 93 sites in 14 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

  • Presence of a pacemaker

Who the study is looking for

  • 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

Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (93)

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

SiteCityCountrySite status
Medizinische Universität Graz
Coordinator of this site? Confirm its status
GrazAustriaRecruiting
Monash Health Victorian Heart Hospital
Coordinator of this site? Confirm its status
ClaytonAustraliaRecruiting
Austin Hospital
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HeidelbergAustraliaRecruiting
OLV Hospital
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AalstBelgiumRecruiting
ZAS Middelheim
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AntwerpBelgiumRecruiting
Az Sint Jan Brugge
Coordinator of this site? Confirm its status
BrugesBelgiumRecruiting
University Hospital UMHAT Sveti Georgi
Coordinator of this site? Confirm its status
PlovdivBulgariaRecruiting
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)
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MontrealCanadaRecruiting
Southlake Regional Hospital Centre
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NewmarketCanadaRecruiting
Kardiocentrum Nemocnice AGEL Trinec-Podlesi
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TřinecCzechiaRecruiting
Marienkrankenhaus
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HamburgGermanyTerminated
Universitätsklinikum Schleswig-Holstein (UKSH)
Coordinator of this site? Confirm its status
LübeckGermanyRecruiting
Universitätsklinikum Kardiologie
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MagdeburgGermanyRecruiting
Germans Trias i Pujol University Hospital
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BarcelonaSpainTerminated
Vall d'Hebron University Hospital Barcelona
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BarcelonaSpainRecruiting
Barcelona Hospital del Mar
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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 Puerta del Cadíz
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CadizSpainTerminated
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
Shaare Zedek Medical Center
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JerusalemIsraelTerminated
Tel-Aviv Sourasky Medical Center
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Tel AvivIsraelRecruiting
Shamir Medical Center
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ZrifinIsraelRecruiting
Instituto Auxologico Italiano
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MilanItalyRecruiting
Humanitas Research Milan
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RozzanoItalyTerminated
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
Poznan University of Medical Sciences
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PoznanPolandRecruiting
Kashubian Center for Heart and Vascular Diseases, Pomeranian
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WejherowoPolandRecruiting
4th Military Hospital
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WroclawPolandRecruiting
Uniwesytecki Szpital Kliniczny
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WroclawPolandRecruiting
Silesian Center for Heart Disease
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ZabrzePolandRecruiting
Hendrick Health
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AbileneUnited StatesRecruiting
VA Ann Arbor
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Ann ArborUnited StatesRecruiting
Mission Hospital
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AshevilleUnited StatesRecruiting
Austin Heart
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AustinUnited StatesRecruiting
Johns Hopkins Medical Institution
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BaltimoreUnited StatesRecruiting
Brigham and Women's Hospital
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BostonUnited StatesRecruiting
Boston Medical Center
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BostonUnited StatesRecruiting
Steward St. Elizabeth's Medical Center
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BrightonUnited StatesTerminated
Medical University of South Carolina
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CharlestonUnited StatesRecruiting
Advocate Illinois Masonic Medical Center
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ChicagoUnited StatesTerminated
Cleveland Clinic
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ClevelandUnited StatesRecruiting
Prisma Health - Midlands
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ColombiaUnited StatesRecruiting
UT Southwestern
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DallasUnited StatesRecruiting
Atlanta VA Health Care System
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DecaturUnited StatesRecruiting
Ascension St. John Hospital
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DetroitUnited StatesTerminated
Duke University Hospital
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DurhamUnited StatesRecruiting
St. Elizabeth Healthcare
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EdgewoodUnited StatesRecruiting
The Cardiac and Vascular Institute (TCAVI)
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GainesvilleUnited StatesRecruiting
Stern Cardiovascular Foundation
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GermantownUnited StatesRecruiting
Pinnacle Health Cardiovascular Institute
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HarrisburgUnited StatesRecruiting
Hartford Hospital
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HartfordUnited StatesTerminated
Cardiovascular Institute of the South
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HoumaUnited StatesRecruiting
Indiana University
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IndianapolisUnited StatesRecruiting
HCA Florida Memorial Hospital
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JacksonvilleUnited StatesRecruiting
Tennova Healthcare-Turkey Creek Medical Center
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KnoxvilleUnited StatesRecruiting
UMC of Southern Nevada
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Las VegasUnited StatesRecruiting
Memorial Care Long Beach Medical Center
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Long BeachUnited StatesRecruiting
Advocate Aurora Health/Aurora Research Institute
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MilwaukeeUnited StatesActive, not recruiting
Minneapolis Heart Institute Foundation
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MinneapolisUnited StatesRecruiting
Midwest Cardiovascular Institute
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NapervilleUnited StatesRecruiting
NCH Research Institute
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NaplesUnited StatesRecruiting
University Medical Center New Orleans
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New OrleansUnited StatesRecruiting
VA NY Harbor Healthcare System
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New YorkUnited StatesTerminated
New York University
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New YorkUnited StatesRecruiting
Lenox Hill Hospital
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New YorkUnited StatesActive, not recruiting
South Oklahoma Heart Research LLC
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Oklahoma CityUnited StatesRecruiting
Advent Health Orlando
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OrlandoUnited StatesRecruiting
Ascension Sacred Heart
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PensacolaUnited StatesRecruiting
Arizona Cardiovascular Research Center
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PhoenixUnited StatesActive, not recruiting
Baylor Scott & White Research Institute
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PlanoUnited StatesRecruiting
Providence St. Vincent's Medical Center
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PortlandUnited StatesTerminated
NC Heart and Vascular Research
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RaleighUnited StatesRecruiting
Monument Health
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Rapid CityUnited StatesRecruiting
St. Francis Hospital
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RoslynUnited StatesTerminated
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
Santa Barbara Cottage Hospital
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Santa BarbaraUnited StatesRecruiting
HonorHealth
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ScottsdaleUnited StatesTerminated
University of Washington
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SeattleUnited StatesActive, not recruiting
Prairie Education And Research Cooperative
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SpringfieldUnited StatesActive, not recruiting
Washington University St. Louis
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St LouisUnited StatesRecruiting
Stony Brook Medicine
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Stony BrookUnited StatesRecruiting
ProMedica Toledo Hospital
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ToledoUnited StatesRecruiting
PIMA Heart and Vascular
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TucsonUnited StatesRecruiting
Waco Cardiology
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WacoUnited StatesRecruiting

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