Clinical trialNCT06812533RecruitingInterventional

Alleviant ALLAY-HFrEF Study

SponsorAlleviant Medical, Inc.Enrollment350Heart Failure

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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.

Gregg Stone
Icahn School of Medicine at Mount Sinai
Principal Investigator
clinicaltrials.gov ↗
James Udelson
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

67 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
Recruiting
Alfred Hospital
Melbourne, Victoria, Australia
David Kaye
Recruiting

Belgium

Olv Hospital
Aalst, Belgium
Jozef Bartunek, Prof.
Recruiting
Zas Middelheim
Antwerp, Belgium
Stefan Verheye
Recruiting
Az Sint Jan Brugge
Bruges, Belgium
Jan Van der Heyden, Prof.
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
Iucpq - Université Laval (quebec)
Québec, Quebec, Canada
Josep Rodés-Cabau, MD, PhD
Recruiting

Georgia

Tbilisi Heart and Vascular
Tbilisi, Georgia
Tamaz Shaburishvili
Recruiting

Greece

Hippocration General Hospital Athens
Athens, Greece
Konstantinos Toutouzas
Recruiting
Hygeia Hospital
Athens, Greece
Elias Tsougos
Recruiting
European Interbalken Medical Center
Thessaloniki, Greece
Vlasis Ninios
Recruiting

Israel

Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Michael Laufer-Perl
Recruiting
Shamir Medical Center
Zrifin, Israel
Gil Moravsky
Recruiting

New Zealand

Christchurch Hospital
Christchurch, New Zealand
Richard Troughton
Recruiting
Dunedin Hospital
Dunedin, New Zealand
Gerard Wilkins
Recruiting

Poland

University Clinical Hospital in Opole
Opole, Poland
Jerzy Sacha
Recruiting
Narodowy Instytut Kardiologii Im. Stefana Kardynała Wyszyńsk
Warsaw, Poland
Przemysław Leszek
Recruiting
Uniwesytecki Szpital Kliniczny
Wroclaw, Poland
Jan Biegus, Prof.
Recruiting

Spain

Hospital Universitario A Coruna
A Coruña, Spain
Maria Generosa Crespo Leiro, Prof.
Recruiting
Hospital Clinic de Barcelona
Barcelona, Spain
Omar Abdul-Jawad Altisent
Recruiting
Hospital de la Santa Creu I Sant Pau
Barcelona, Spain
Sonia Mirabet, MD, PhD
Recruiting
Vall D'Hebron University Hospital Barcelona
Barcelona, Spain
Eduardo Rodenas-Alesina
Recruiting
Hospital Universitario 12 de Octubre
Madrid, Spain
Javier de Juan Bagudá
Recruiting
Hospital Universitario Puerta de Hierro
Madrid, Spain
Marta Cobo Marcos, Prof.
Recruiting
Hospital Clínico Universitario de Salamanca
Salamanca, Spain
David González Calle, MD
Recruiting
Valencia Hospital Clinico
Valencia, Spain
Julio Nunez
Recruiting

United States

Keck Medical Center of Usc
Los Angeles, California, United States
Michael Fong, MD
Recruiting
University California Los Angeles Medical Center
Los Angeles, California, United States
Richard Cheng, MD
Recruiting
Uc Davis Medical Center
Sacramento, California, United States
Tai Pham, MD
Recruiting
Scripps Clinical Research Services
San Diego, California, United States
Rajeev Mohan, MD
Recruiting
University of California San Francisco
San Francisco, California, United States
Liviu Klein, MD
Recruiting
Delray Medical Center
Delray Beach, Florida, United States
Philip Habib, MD
Recruiting
Ascension Sacred Heart
Pensacola, Florida, United States
Rohit Amin, MD
Recruiting
Tampa General Hospital
Tampa, Florida, United States
Jason Feliberti, MD
Recruiting
Atlanta Va Health Care System
Decatur, Georgia, United States
Gautum Kumar, MD
Recruiting
Midwest Cardiovascular Institute
Naperville, Illinois, United States
Stanislaw Skaluba, MD
Recruiting
Cardiovascular Institute of the South
Houma, Louisiana, United States
Peter Fail, MD
Recruiting
University Medical Center New Orleans
New Orleans, Louisiana, United States
Frank Smart, MD
Recruiting

27 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 Mar 2025
Primary completion: 31 Dec 2028
Completion: 31 Dec 2028
Last update posted: 14 Aug 2026
Registered enrollment: 350
Registry id: NCT06812533

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.