Clinical trialNCT05685303RecruitingInterventional

Alleviant ALLAY-HF Study

SponsorAlleviant Medical, Inc.Enrollment700Heart Failure

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

James Udelson, MD
Tufts Medical Center
Principal InvestigatorKOL profile →
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

93 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Australia

Monash Health Victorian Heart Hospital
Clayton, Victoria, Australia
Robert Gooley, A/Prof
Recruiting
Austin Hospital
Heidelberg, Victoria, Australia
Matias Yudi
Recruiting

Austria

Medizinische Universität Graz
Graz, Austria
Gabor Toth, MD, PhD
Recruiting

Belgium

Olv Hospital
Aalst, Belgium
Martin Penicka, MD, PhD
Recruiting
Zas Middelheim
Antwerp, Belgium
Stefan Verheye
Recruiting
Az Sint Jan Brugge
Bruges, Belgium
Jan Van der Heyden, MD, PhD
Recruiting

Bulgaria

University Hospital Umhat Sveti Georgi
Plovdiv, Bulgaria
Krasimir Dzhinsov
Recruiting

Canada

Southlake Regional Hospital Centre
Newmarket, Ontario, Canada
Liane Porepa, MD
Recruiting
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
Benoit Daneault, MD
Recruiting
Centre Hospitalier de L'Universite de Montreal (chum)
Montreal, Quebec, Canada
Brian Potter, MD
Recruiting

Czechia

Kardiocentrum Nemocnice Agel Trinec-Podlesi
Třinec, Czechia
Jaroslav Januska
Recruiting

Georgia

Tbilisi Heart and Vascular
Tbilisi, Georgia
Tamaz Shaburishvili
Recruiting

Germany

Marienkrankenhaus
Hamburg, Germany
Terminated
Universitatsklinikum Schleswig-Holstein (uksh)
Lübeck, Germany
Tobias Schmidt, MD
Recruiting
Universitätsklinikum Kardiologie
Magdeburg, Germany
Rüdiger Braun-Dullaeus, MD, PhD
Recruiting

Israel

Shaare Zedek Medical Center
Jerusalem, Israel
Terminated
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Michal Laufer-Perl, MD
Recruiting
Shamir Medical Center
Zrifin, Israel
Gil Moravsky, MD
Recruiting

Italy

Humanitas Research Milan
Rozzano, Michigan, Italy
Terminated
Instituto Auxologico Italiano
Milan, Italy
Sergio Caravita, MD, PhD
Recruiting

New Zealand

Christchurch Hospital
Christchurch, New Zealand
Richard Troughton, PhD
Recruiting
Dunedin Hospital
Dunedin, New Zealand
Gerry Wilkins, A/Prof
Recruiting

Poland

University Clinical Hospital in Opole
Opole, Poland
Jerzy Sacha
Recruiting
Poznan University of Medical Sciences
Poznan, Poland
Marek Grygier, MD, PhD
Recruiting
Kashubian Center for Heart and Vascular Diseases, Pomeranian
Wejherowo, Poland
Lukasz Lewicki
Recruiting
4th Military Hospital
Wroclaw, Poland
Bartek Krakowiak, MD, PhD
Recruiting
Uniwesytecki Szpital Kliniczny
Wroclaw, Poland
Jan Leon Biegus, MD, PhD
Recruiting
Silesian Center for Heart Disease
Zabrze, Poland
Michal Hawranek
Recruiting

Spain

Barcelona Hospital del Mar
Barcelona, Spain
Nuria Farre, MD
Recruiting
Germans Trias I Pujol University Hospital
Barcelona, Spain
Terminated
Hospital Clinic de Barcelona
Barcelona, Spain
Omar Abdul-Jawad Altisent, MD, PhD
Recruiting
Hospital de la Santa Creu I Sant Pau
Barcelona, Spain
Sonia Mirabel, MD, PhD
Recruiting
Vall D'Hebron University Hospital Barcelona
Barcelona, Spain
Eduard Ródenas-Alesina
Recruiting
Hospital Universitario Puerta del Cadíz
Cadiz, Spain
Terminated
Hospital Universitario Puerta de Hierro
Madrid, Spain
Marta Cobo Marcos, MD
Recruiting
Hospital Clínico Universitario de Salamanca
Salamanca, Spain
Inès Maria Toranzo Nieto
Recruiting
Valencia Hospital Clinico
Valencia, Spain
Julio Nunez, MD, PhD
Recruiting

United States

Arizona Cardiovascular Research Center
Phoenix, Arizona, United States
Active, not recruiting
Honorhealth
Scottsdale, Arizona, United States
Terminated
Pima Heart and Vascular
Tucson, Arizona, United States
Thomas Waggoner, DO
Recruiting

53 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 10 Jan 2023
Primary completion: 1 Dec 2027
Completion: 1 Dec 2032
Last update posted: 14 Aug 2026
Registered enrollment: 700
Registry id: NCT05685303

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.