Alleviant ALLAY-HF Study
Start Date
1/10/2023
Completion Date
12/1/2032
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
Age Range: 40 years to No maximum
Interventions
Alleviant ALV1 System
Sham-Control
Conditions
Locations
Arizona Cardiovascular Research Center
Phoenix, Arizona 85016
United States
HonorHealth
Scottsdale, Arizona 85258
United States
Pima Heart and Vascular
Tucson, Arizona 85718
United States
Memorial Care Long Beach Medical Center
Long Beach, California 90806
United States
UC Davis Medical Center
Sacramento, California 95817
United States
Scripps Clinical Research Services
San Diego, California 92121
United States
University of California San Francisco
San Francisco, California 94143
United States
Santa Barbara Cottage Hospital
Santa Barbara, California 93105
United States
Hartford Hospital
Hartford, Connecticut 06106
United States
The Cardiac and Vascular Institute (TCAVI)
Gainesville, Florida 32504
United States
HCA Florida Memorial Hospital
Jacksonville, Florida 32216
United States
NCH Research Institute
Naples, Florida 34102
United States
Advent Health Orlando
Orlando, Florida 32803
United States
Ascension Sacred Heart
Pensacola, Florida 32504
United States
Atlanta VA Health Care System
Decatur, Georgia 30032
United States
Advocate Illinois Masonic Medical Center
Chicago, Illinois 60657
United States
Midwest Cardiovascular Institute
Naperville, Illinois 60540
United States
Prairie Education and Research Cooperative
Springfield, Illinois 62769
United States
Indiana University
Indianapolis, Indiana 46202
United States
St. Elizabeth Healthcare
Edgewood, Kentucky 41017
United States
Cardiovascular Institute of the South
Houma, Louisiana 70360
United States
University Medical Center New Orleans
New Orleans, Louisiana 70112
United States
Johns Hopkins Medical Institution
Baltimore, Maryland 21287
United States
Brigham and Women's Hospital
Boston, Massachusetts 02115
United States
Boston Medical Center
Boston, Massachusetts 02118
United States
Steward St. Elizabeth's Medical Center
Brighton, Massachusetts 02135
United States
VA Ann Arbor
Ann Arbor, Michigan 48105
United States
Ascension St. John Hospital
Detroit, Michigan 48236
United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota 55407
United States
Washington University - St Louis
St Louis, Missouri 63110
United States
UMC of Southern Nevada
Las Vegas, Nevada 89102
United States
VA NY Harbor Healthcare System
New York, New York 10010
United States
New York University
New York, New York 10016
United States
Lenox Hill Hospital
New York, New York 10075
United States
St. Francis Hospital
Roslyn, New York 11576
United States
Stony Brook Medicine
Stony Brook, New York 11794-8167
United States
Mission Hospital
Asheville, North Carolina 28801
United States
Duke University Hospital
Durham, North Carolina 27705
United States
NC Heart and Vascular Research
Raleigh, North Carolina 27607
United States
Cleveland Clinic
Cleveland, Ohio 44195
United States
ProMedica Toledo Hospital
Toledo, Ohio 43606
United States
South Oklahoma Heart Research, LLC.
Oklahoma City, Oklahoma 73135
United States
Providence St. Vincent's Medical Center
Portland, Oregon 97225
United States
Pinnacle Health Cardiovascular Institute
Harrisburg, Pennsylvania 17101
United States
Medical University of South Carolina
Charleston, South Carolina 29425
United States
Prisma Health - Midlands
Colombia, South Carolina 29203
United States
Monument Health
Rapid City, South Dakota 57701
United States
Stern Cardiovascular Foundation
Germantown, Tennessee 38138
United States
Tennova Healthcare - Turkey Creek Medical Center
Knoxville, Tennessee 37934
United States
Hendrick Health
Abilene, Texas 79601
United States
Austin Heart
Austin, Texas 78756
United States
UT Southwestern
Dallas, Texas 75930
United States
Baylor Scott & White Research Institute
Plano, Texas 75093
United States
Waco Cardiology
Waco, Texas 76712
United States
University of Washington
Seattle, Washington 98195
United States
Advocate Aurora Health/Aurora Research Institute
Milwaukee, Wisconsin 53215
United States
Monash Health Victorian Heart Hospital
Clayton, Victoria 3068
Australia
Austin Hospital
Heidelberg, Victoria 3084
Australia
Medizinische Universität Graz
Graz,
Austria
OLV Hospital
Aalst,
Belgium
ZAS Middelheim
Antwerp,
Belgium
AZ Sint Jan Brugge
Bruges,
Belgium
University Hospital UMHAT Sveti Georgi
Plovdiv, 4002
Bulgaria
Southlake Regional Hospital Centre
Newmarket, Ontario L3Y 2P6
Canada
Centre hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec H2X 0C1
Canada
Centre Integre Universitaire de Sainte et de Services Scoiiaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CIUSSS de l'Estrie - CHUS)
Montreal, Quebec H2X 0C1
Canada
Kardiocentrum Nemocnice AGEL Trinec-Podlesi
Třinec, 73961
Czechia
Tbilisi Heart and Vascular
Tbilisi,
Georgia
Marienkrankenhaus
Hamburg, 22087
Germany
Universitatsklinikum Schleswig-Holstein (UKSH)
Lübeck, 23538
Germany
Universitätsklinikum Kardiologie
Magdeburg, 39120
Germany
Shaare Zedek Medical Center
Jerusalem,
Israel
Tel Aviv Sourasky Medical Center
Tel Aviv,
Israel
Shamir Medical Center
Zrifin,
Israel
Humanitas Research Milan
Rozzano, Michigan
Italy
Instituto Auxologico Italiano
Milan, 20149
Italy
ChristChurch Hospital
Christchurch, 8011
New Zealand
Dunedin Hospital
Dunedin, 9016
New Zealand
University Clinical Hospital in Opole
Opole,
Poland
Poznan University of Medical Sciences
Poznan,
Poland
Kashubian Center for Heart and Vascular Diseases, Pomeranian
Wejherowo, 84-200
Poland
4th Military Hospital
Wroclaw,
Poland
Uniwesytecki Szpital Kliniczny
Wroclaw,
Poland
Silesian Center for Heart Disease
Zabrze,
Poland
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Spain
Barcelona Hospital del Mar
Barcelona, 08033
Spain
Hospital Clinic de Barcelona
Barcelona, 08036
Spain
Germans Trias i Pujol University Hospital
Barcelona, 08916
Spain
Vall d'Hebron University Hospital Barcelona
Barcelona,
Spain
Hospital Universitario Puerta del Cadíz
Cadiz, 11009
Spain
Hospital Universitario Puerta de Hierro
Madrid, 28222
Spain
Hospital Clínico Universitario de Salamanca
Salamanca,
Spain
Valencia Hospital Clinico
Valencia, 46010
Spain