Alleviant ALLAY-HF Study
- Conditions
- Heart Failure
- Interventions
- Other: Sham-ControlDevice: Alleviant ALV1 System
- Registration Number
- NCT05685303
- Lead Sponsor
- Alleviant Medical, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 500
-
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
- Advanced heart failure
- Presence of a pacemaker
- Evidence of right heart dysfunction
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Control Sham-Control Subjects randomized to the control arm will undergo cardiac imaging and sheath placement in femoral vein. Treatment Alleviant ALV1 System Subjects randomized to the treatment arm will undergo cardiac imaging, femoral vein access and receive the Alleviant ALV1 System device procedure.
- Primary Outcome Measures
Name Time Method Composite Primary Endpoint 12-month The primary endpoint is a composite of mortality, heart failure events and quality of life based on Kansas City Cardiomyopathy Questionnaire (KCCQ) calculated at 12 months. KCCQ responses are provided along a rating scale from 0-100 with a higher score indicating better health.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (87)
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Barcelona Hospital del Mar
🇪🇸Barcelona, Spain
University of Alabama
🇺🇸Birmingham, Alabama, United States
Arizona Cardiovascular Research Center
🇺🇸Phoenix, Arizona, United States
Pima Heart and Vascular
🇺🇸Tucson, Arizona, United States
Memorial Care Long Beach Medical Center
🇺🇸Long Beach, California, United States
Scripps Clinical Research Services
🇺🇸San Diego, California, United States
San Francisco VA
🇺🇸San Francisco, California, United States
University of California San Francisco
🇺🇸San Francisco, California, United States
Santa Barbara Cottage Hospital
🇺🇸Santa Barbara, California, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
The Cardiac and Vascular Institute (TCAVI)
🇺🇸Gainesville, Florida, United States
HCA Florida Memorial Hospital
🇺🇸Jacksonville, Florida, United States
NCH Research Institute
🇺🇸Naples, Florida, United States
Advent Health Orlando
🇺🇸Orlando, Florida, United States
Ascension Sacred Heart
🇺🇸Pensacola, Florida, United States
Atlanta VA Health Care System
🇺🇸Decatur, Georgia, United States
Advocate Illinois Masonic Medical Center
🇺🇸Chicago, Illinois, United States
Midwest Cardiovascular Institute
🇺🇸Naperville, Illinois, United States
Prairie Education and Research Cooperative
🇺🇸Springfield, Illinois, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
St. Elizabeth Healthcare
🇺🇸Edgewood, Kentucky, United States
Cardiovascular Institute of the South
🇺🇸Houma, Louisiana, United States
University Medical Center New Orleans
🇺🇸New Orleans, Louisiana, United States
Johns Hopkins Medical Institution
🇺🇸Baltimore, Maryland, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
VA Ann Arbor
🇺🇸Ann Arbor, Michigan, United States
Minneapolis Heart Institute Foundation
🇺🇸Minneapolis, Minnesota, United States
VA NY Harbor Healthcare System
🇺🇸New York, New York, United States
New York University
🇺🇸New York, New York, United States
Lenox Hill Hospital
🇺🇸New York, New York, United States
St. Francis Hospital
🇺🇸Roslyn, New York, United States
Stony Brook Medicine
🇺🇸Stony Brook, New York, United States
Mission Hospital
🇺🇸Asheville, North Carolina, United States
Duke University Hospital
🇺🇸Durham, North Carolina, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
ProMedica Toledo Hospital
🇺🇸Toledo, Ohio, United States
South Oklahoma Heart Research, LLC.
🇺🇸Oklahoma City, Oklahoma, United States
Providence St. Vincent's Medical Center
🇺🇸Portland, Oregon, United States
Pinnacle Health Cardiovascular Institute
🇺🇸Harrisburg, Pennsylvania, United States
Prisma Health - Midlands
🇺🇸Colombia, South Carolina, United States
Monument Health
🇺🇸Rapid City, South Dakota, United States
Stern Cardiovascular Foundation
🇺🇸Germantown, Tennessee, United States
Tennova Healthcare - Turkey Creek Medical Center
🇺🇸Knoxville, Tennessee, United States
Hendrick Health
🇺🇸Abilene, Texas, United States
Austin Heart
🇺🇸Austin, Texas, United States
UT Southwestern
🇺🇸Dallas, Texas, United States
Baylor Scott & White Research Institute
🇺🇸Plano, Texas, United States
NextStage Clinical Research
🇺🇸Waco, Texas, United States
University of Washington
🇺🇸Seattle, Washington, United States
Advocate Aurora Health/Aurora Research Institute
🇺🇸Milwaukee, Wisconsin, United States
Monash Health Victorian Heart Hospital
🇦🇺Clayton, Victoria, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, Australia
Medizinische Universität Graz
🇦🇹Graz, Austria
OLV Hospital
🇧🇪Aalst, Belgium
ZNA Middelheim
🇧🇪Antwerpen, Belgium
AZ Sint Jan Brugge
🇧🇪Bruges, Belgium
Southlake Regional Hospital Centre
🇨🇦Newmarket, Ontario, Canada
Centre hospitalier de l'Universite de Montreal (CHUM)
🇨🇦Montréal, Quebec, Canada
Centre Integre Universitaire de Sainte et de Services Scoiiaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CIUSSS de l'Estrie - CHUS)
🇨🇦Montréal, Quebec, Canada
Tbilisi Heart and Vascular
🇬🇪Tbilisi, Georgia
Heart and Vascular Center-Bad Bevensen
🇩🇪Bad Bevensen, Germany
Herz- und Gefasszentrum Bad Bevensen
🇩🇪Bad Bevensen, Germany
University of Gießen
🇩🇪Gießen, Germany
Marienkrankenhaus
🇩🇪Hamburg, Germany
Askelepios Klinik Altona
🇩🇪Hamburg, Germany
St. Vincentius Kliniken
🇩🇪Karlsruhe, Germany
Universitatsklinikum Schleswig-Holstein (UKSH)
🇩🇪Luebeck, Germany
Universitätsklinikum Kardiologie
🇩🇪Magdeburg, Germany
Universitatsmedizin Rostock
🇩🇪Rostock, Germany
European Interbalken Medical Center
🇬🇷ThessalonÃki, Greece
Shaare Zedek Medical Center
🇮🇱Jerusalem, Israel
Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Shamir Medical Center
🇮🇱Zrifin, Israel
Humanitas Research Milan
🇮🇹Rozzano, MI, Italy
Instituto Auxologico Italiano
🇮🇹Milan, Italy
ChristChurch Hospital
🇳🇿Christchurch, New Zealand
Dunedin Hospital
🇳🇿Dunedin, New Zealand
Poznan University of Medical Sciences
🇵🇱Poznań, Poland
4th Military Hospital
🇵🇱Wrocław, Poland
Uniwesytecki Szpital Kliniczny
🇵🇱Wrocław, Poland
Silesian Center for Heart Disease
🇵🇱Zabrze, Poland
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Hospital Universitario Puerta de Hierro
🇪🇸Madrid, Spain
Hospital ClÃnico Universitario de Salamanca
🇪🇸Salamanca, Spain
Valencia Hospital Clinico
🇪🇸Valencia, Spain