Clinical trial NCT05685303: Alleviant ALLAY-HF Study
Official title: Safety and Efficacy of the Alleviant System for No-Implant Interatrial Shunt Creation in Patients With Chronic Heart Failure
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Heart Failure
Lead sponsor: Alleviant Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2023-01-17
Enrollment: 500
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Symptomatic HFpEF/HFmrEF with LVEF greater than or equal to 40%
2. NYHA Class II, III or ambulatory IV
3. Exercise right heart catheterization\*

   1. Elevated left atrial pressure during exercise right heart catheterization (greater than or equal to 25 mmHg)
   2. Exercise PVR \< 1.8 WU
4. Ongoing stable GDMT

Exclusion Criteria:

1. Advanced heart failure
2. Presence of a pacemaker
3. Evidence of right heart dysfunction

Primary outcomes:
measure: Composite Primary Endpoint
timeFrame: 12-month
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Phoenix
country: United States
facility: Arizona Cardiovascular Research Center
state: Arizona
city: Tucson
country: United States
facility: Pima Heart and Vascular
state: Arizona
city: Long Beach
country: United States
facility: Memorial Care Long Beach Medical Center
state: California
city: San Diego
country: United States
facility: Scripps Clinical Research Services
state: California
city: San Francisco
country: United States
facility: San Francisco VA
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Santa Barbara
country: United States
facility: Santa Barbara Cottage Hospital
state: California
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Gainesville
country: United States
facility: The Cardiac and Vascular Institute (TCAVI)
state: Florida
city: Jacksonville
country: United States
facility: HCA Florida Memorial Hospital
state: Florida
city: Naples
country: United States
facility: NCH Research Institute
state: Florida
city: Orlando
country: United States
facility: Advent Health Orlando
state: Florida
city: Pensacola
country: United States
facility: Ascension Sacred Heart
state: Florida
city: Decatur
country: United States
facility: Atlanta VA Health Care System
state: Georgia
city: Chicago
country: United States
facility: Advocate Illinois Masonic Medical Center
state: Illinois
city: Naperville
country: United States
facility: Midwest Cardiovascular Institute
state: Illinois
city: Springfield
country: United States
facility: Prairie Education and Research Cooperative
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Edgewood
country: United States
facility: St. Elizabeth Healthcare
state: Kentucky
city: Houma
country: United States
facility: Cardiovascular Institute of the South
state: Louisiana
city: New Orleans
country: United States
facility: University Medical Center New Orleans
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins Medical Institution
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: VA Ann Arbor
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute Foundation
state: Minnesota
city: New York
country: United States
facility: VA NY Harbor Healthcare System
state: New York
city: New York
country: United States
facility: New York University
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: Roslyn
country: United States
facility: St. Francis Hospital
state: New York
city: Stony Brook
country: United States
facility: Stony Brook Medicine
state: New York
city: Asheville
country: United States
facility: Mission Hospital
state: North Carolina
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Toledo
country: United States
facility: ProMedica Toledo Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: South Oklahoma Heart Research, LLC.
state: Oklahoma
city: Portland
country: United States
facility: Providence St. Vincent's Medical Center
state: Oregon
city: Harrisburg
country: United States
facility: Pinnacle Health Cardiovascular Institute
state: Pennsylvania
city: Colombia
country: United States
facility: Prisma Health - Midlands
state: South Carolina
city: Rapid City
country: United States
facility: Monument Health
state: South Dakota
city: Germantown
country: United States
facility: Stern Cardiovascular Foundation
state: Tennessee
city: Knoxville
country: United States
facility: Tennova Healthcare - Turkey Creek Medical Center
state: Tennessee
city: Abilene
country: United States
facility: Hendrick Health
state: Texas
city: Austin
country: United States
facility: Austin Heart
state: Texas
city: Dallas
country: United States
facility: UT Southwestern
state: Texas
city: Plano
country: United States
facility: Baylor Scott & White Research Institute
state: Texas
city: Waco
country: United States
facility: NextStage Clinical Research
state: Texas
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Milwaukee
country: United States
facility: Advocate Aurora Health/Aurora Research Institute
state: Wisconsin
city: Clayton
country: Australia
facility: Monash Health Victorian Heart Hospital
state: Victoria
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
city: Graz
country: Austria
facility: Medizinische Universität Graz
city: Aalst
country: Belgium
facility: OLV Hospital
city: Antwerpen
country: Belgium
facility: ZNA Middelheim
city: Bruges
country: Belgium
facility: AZ Sint Jan Brugge
city: Newmarket
country: Canada
facility: Southlake Regional Hospital Centre
state: Ontario
city: Montréal
country: Canada
facility: Centre hospitalier de l'Universite de Montreal (CHUM)
state: Quebec
city: Montréal
country: Canada
facility: Centre Integre Universitaire de Sainte et de Services Scoiiaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CIUSSS de l'Estrie - CHUS)
state: Quebec
city: Tbilisi
country: Georgia
facility: Tbilisi Heart and Vascular
city: Bad Bevensen
country: Germany
facility: Heart and Vascular Center-Bad Bevensen
city: Bad Bevensen
country: Germany
facility: Herz- und Gefasszentrum Bad Bevensen
city: Gießen
country: Germany
facility: University of Gießen
city: Hamburg
country: Germany
facility: Marienkrankenhaus
city: Hamburg
country: Germany
facility: Askelepios Klinik Altona
city: Karlsruhe
country: Germany
facility: St. Vincentius Kliniken
city: Luebeck
country: Germany
facility: Universitatsklinikum Schleswig-Holstein (UKSH)
city: Magdeburg
country: Germany
facility: Universitätsklinikum Kardiologie
city: Rostock
country: Germany
facility: Universitatsmedizin Rostock
city: Thessaloníki
country: Greece
facility: European Interbalken Medical Center
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Zrifin
country: Israel
facility: Shamir Medical Center
city: Rozzano
country: Italy
facility: Humanitas Research Milan
state: MI
city: Milan
country: Italy
facility: Instituto Auxologico Italiano
city: Christchurch
country: New Zealand
facility: ChristChurch Hospital
city: Dunedin
country: New Zealand
facility: Dunedin Hospital
city: Poznań
country: Poland
facility: Poznan University of Medical Sciences
city: Wrocław
country: Poland
facility: 4th Military Hospital
city: Wrocław
country: Poland
facility: Uniwesytecki Szpital Kliniczny
city: Zabrze
country: Poland
facility: Silesian Center for Heart Disease
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Barcelona Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro
city: Salamanca
country: Spain
facility: Hospital Clínico Universitario de Salamanca
city: Valencia
country: Spain
facility: Valencia Hospital Clinico
Study officials:
affiliation: Tufts Medical Center
name: James Udelson, MD
role: PRINCIPAL_INVESTIGATOR
References: