Alleviant ALLAY-HF Study

Phase

N/A

Condition

Chest Pain

Congestive Heart Failure

Heart Failure

Treatment

Sham-Control

Alleviant ALV1 System

Clinical Study ID

NCT05685303

CIP-0003

Ages > 40
All Genders

Study 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

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

Advanced heart failure
Presence of a pacemaker
Evidence of right heart dysfunction

Study Design

Sham-Control

January 10, 2023

December 01, 2032

Connect with a study center

Monash Health Victorian Heart Hospital
Clayton, Victoria 3068
Australia
Active - Recruiting
Austin Hospital
Heidelberg, Victoria 3084
Australia
Active - Recruiting
Medizinische Universität Graz
Graz,
Austria
Active - Recruiting
OLV Hospital
Aalst,
Belgium
Active - Recruiting
ZAS Middelheim
Antwerp,
Belgium
Active - Recruiting
AZ Sint Jan Brugge
Bruges,
Belgium
Active - Recruiting
University Hospital UMHAT Sveti Georgi
Plovdiv, 4002
Bulgaria
Active - Recruiting
Southlake Regional Hospital Centre
Newmarket, Ontario L3Y 2P6
Canada
Active - 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 H2X 0C1
Canada
Active - Recruiting
Centre hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec H2X 0C1
Canada
Active - Recruiting
Kardiocentrum Nemocnice AGEL Trinec-Podlesi
Třinec, 73961
Czechia
Active - Recruiting
Tbilisi Heart and Vascular
Tbilisi,
Georgia
Active - Recruiting
Marienkrankenhaus
Hamburg, 22087
Germany
Terminated
Universitatsklinikum Schleswig-Holstein (UKSH)
Lübeck, 23538
Germany
Active - Recruiting
Universitätsklinikum Kardiologie
Magdeburg, 39120
Germany
Active - Recruiting
Shaare Zedek Medical Center
Jerusalem,
Israel
Terminated
Tel Aviv Sourasky Medical Center
Tel Aviv,
Israel
Active - Recruiting
Shamir Medical Center
Zrifin,
Israel
Active - Recruiting
Humanitas Research Milan
Rozzano, Michigan
Italy
Terminated
Instituto Auxologico Italiano
Milan, 20149
Italy
Active - Recruiting
ChristChurch Hospital
Christchurch, 8011
New Zealand
Active - Recruiting
Dunedin Hospital
Dunedin, 9016
New Zealand
Active - Recruiting
University Clinical Hospital in Opole
Opole,
Poland
Active - Recruiting
Poznan University of Medical Sciences
Poznan,
Poland
Active - Recruiting
Kashubian Center for Heart and Vascular Diseases, Pomeranian
Wejherowo, 84-200
Poland
Active - Recruiting
4th Military Hospital
Wroclaw,
Poland
Active - Recruiting
Uniwesytecki Szpital Kliniczny
Wroclaw,
Poland
Active - Recruiting
Silesian Center for Heart Disease
Zabrze,
Poland
Active - Recruiting
Barcelona Hospital del Mar
Barcelona, 08033
Spain
Active - Recruiting
Germans Trias i Pujol University Hospital
Barcelona, 08916
Spain
Terminated
Hospital Clinic de Barcelona
Barcelona, 08036
Spain
Active - Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Spain
Active - Recruiting
Vall d'Hebron University Hospital Barcelona
Barcelona,
Spain
Active - Recruiting
Hospital Universitario Puerta del Cadíz
Cadiz, 11009
Spain
Terminated
Hospital Universitario Puerta de Hierro
Madrid, 28222
Spain
Active - Recruiting
Hospital Clínico Universitario de Salamanca
Salamanca,
Spain
Active - Recruiting
Valencia Hospital Clinico
Valencia, 46010
Spain
Active - Recruiting
Arizona Cardiovascular Research Center
Phoenix, Arizona 85016
United States
Site Not Available
HonorHealth
Scottsdale, Arizona 85258
United States
Terminated
Pima Heart and Vascular
Tucson, Arizona 85718
United States
Active - Recruiting
Memorial Care Long Beach Medical Center
Long Beach, California 90806
United States
Active - Recruiting
UC Davis Medical Center
Sacramento, California 95817
United States
Active - Recruiting
Scripps Clinical Research Services
San Diego, California 92121
United States
Active - Recruiting
University of California San Francisco
San Francisco, California 94143
United States
Active - Recruiting
Santa Barbara Cottage Hospital
Santa Barbara, California 93105
United States
Active - Recruiting
Hartford Hospital
Hartford, Connecticut 06106
United States
Terminated
The Cardiac and Vascular Institute (TCAVI)
Gainesville, Florida 32504
United States
Active - Recruiting
HCA Florida Memorial Hospital
Jacksonville, Florida 32216
United States
Active - Recruiting
NCH Research Institute
Naples, Florida 34102
United States
Active - Recruiting
Advent Health Orlando
Orlando, Florida 32803
United States
Active - Recruiting
Ascension Sacred Heart
Pensacola, Florida 32504
United States
Active - Recruiting
Atlanta VA Health Care System
Decatur, Georgia 30032
United States
Active - Recruiting
Advocate Illinois Masonic Medical Center
Chicago, Illinois 60657
United States
Terminated
Midwest Cardiovascular Institute
Naperville, Illinois 60540
United States
Active - Recruiting
Prairie Education and Research Cooperative
Springfield, Illinois 62769
United States
Site Not Available
Indiana University
Indianapolis, Indiana 46202
United States
Active - Recruiting
St. Elizabeth Healthcare
Edgewood, Kentucky 41017
United States
Active - Recruiting
Cardiovascular Institute of the South
Houma, Louisiana 70360
United States
Active - Recruiting
University Medical Center New Orleans
New Orleans, Louisiana 70112
United States
Active - Recruiting
Johns Hopkins Medical Institution
Baltimore, Maryland 21287
United States
Active - Recruiting
Boston Medical Center
Boston, Massachusetts 02118
United States
Active - Recruiting
Brigham and Women's Hospital
Boston, Massachusetts 02115
United States
Active - Recruiting
Steward St. Elizabeth's Medical Center
Brighton, Massachusetts 02135
United States
Terminated
VA Ann Arbor
Ann Arbor, Michigan 48105
United States
Active - Recruiting
Ascension St. John Hospital
Detroit, Michigan 48236
United States
Terminated
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota 55407
United States
Active - Recruiting
Washington University - St Louis
St Louis, Missouri 63110
United States
Active - Recruiting
UMC of Southern Nevada
Las Vegas, Nevada 89102
United States
Active - Recruiting
Lenox Hill Hospital
New York, New York 10075
United States
Site Not Available
New York University
New York, New York 10016
United States
Active - Recruiting
VA NY Harbor Healthcare System
New York, New York 10010
United States
Terminated
St. Francis Hospital
Roslyn, New York 11576
United States
Terminated
Stony Brook Medicine
Stony Brook, New York 11794-8167
United States
Active - Recruiting
Mission Hospital
Asheville, North Carolina 28801
United States
Active - Recruiting
Duke University Hospital
Durham, North Carolina 27705
United States
Active - Recruiting
NC Heart and Vascular Research
Raleigh, North Carolina 27607
United States
Active - Recruiting
Cleveland Clinic
Cleveland, Ohio 44195
United States
Active - Recruiting
ProMedica Toledo Hospital
Toledo, Ohio 43606
United States
Active - Recruiting
South Oklahoma Heart Research, LLC.
Oklahoma City, Oklahoma 73135
United States
Active - Recruiting
Providence St. Vincent's Medical Center
Portland, Oregon 97225
United States
Terminated
Pinnacle Health Cardiovascular Institute
Harrisburg, Pennsylvania 17101
United States
Active - Recruiting
Medical University of South Carolina
Charleston, South Carolina 29425
United States
Active - Recruiting
Prisma Health - Midlands
Colombia, South Carolina 29203
United States
Active - Recruiting
Monument Health
Rapid City, South Dakota 57701
United States
Active - Recruiting
Stern Cardiovascular Foundation
Germantown, Tennessee 38138
United States
Active - Recruiting
Tennova Healthcare - Turkey Creek Medical Center
Knoxville, Tennessee 37934
United States
Active - Recruiting
Hendrick Health
Abilene, Texas 79601
United States
Active - Recruiting
Austin Heart
Austin, Texas 78756
United States
Active - Recruiting
UT Southwestern
Dallas, Texas 75930
United States
Active - Recruiting
Baylor Scott & White Research Institute
Plano, Texas 75093
United States
Active - Recruiting
Waco Cardiology
Waco, Texas 76712
United States
Active - Recruiting
University of Washington
Seattle, Washington 98195
United States
Site Not Available
Advocate Aurora Health/Aurora Research Institute
Milwaukee, Wisconsin 53215
United States
Site Not Available

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Alleviant ALLAY-HF Study

Phase

Condition

Treatment

Clinical Study ID

Study Summary

Eligibility Criteria

Inclusion

Exclusion

Study Design

Connect with a study center

Monash Health Victorian Heart Hospital

Austin Hospital

Medizinische Universität Graz

OLV Hospital

ZAS Middelheim

AZ Sint Jan Brugge

University Hospital UMHAT Sveti Georgi

Southlake Regional Hospital Centre

Centre Integre Universitaire de Sainte et de Services Scoiiaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CIUSSS de l'Estrie - CHUS)

Centre hospitalier de l'Universite de Montreal (CHUM)

Kardiocentrum Nemocnice AGEL Trinec-Podlesi

Tbilisi Heart and Vascular

Marienkrankenhaus

Universitatsklinikum Schleswig-Holstein (UKSH)

Universitätsklinikum Kardiologie

Shaare Zedek Medical Center

Tel Aviv Sourasky Medical Center

Shamir Medical Center

Humanitas Research Milan

Instituto Auxologico Italiano

ChristChurch Hospital

Dunedin Hospital

University Clinical Hospital in Opole

Poznan University of Medical Sciences

Kashubian Center for Heart and Vascular Diseases, Pomeranian

4th Military Hospital

Uniwesytecki Szpital Kliniczny

Silesian Center for Heart Disease

Barcelona Hospital del Mar

Germans Trias i Pujol University Hospital

Hospital Clinic de Barcelona

Hospital de la Santa Creu i Sant Pau

Vall d'Hebron University Hospital Barcelona

Hospital Universitario Puerta del Cadíz

Hospital Universitario Puerta de Hierro

Hospital Clínico Universitario de Salamanca

Valencia Hospital Clinico

Arizona Cardiovascular Research Center

HonorHealth

Pima Heart and Vascular

Memorial Care Long Beach Medical Center

UC Davis Medical Center

Scripps Clinical Research Services

University of California San Francisco

Santa Barbara Cottage Hospital

Hartford Hospital

The Cardiac and Vascular Institute (TCAVI)

HCA Florida Memorial Hospital

NCH Research Institute

Advent Health Orlando

Ascension Sacred Heart

Atlanta VA Health Care System

Advocate Illinois Masonic Medical Center

Midwest Cardiovascular Institute

Prairie Education and Research Cooperative

Indiana University

St. Elizabeth Healthcare

Cardiovascular Institute of the South

University Medical Center New Orleans

Johns Hopkins Medical Institution

Boston Medical Center

Brigham and Women's Hospital

Steward St. Elizabeth's Medical Center

VA Ann Arbor

Ascension St. John Hospital

Minneapolis Heart Institute Foundation

Washington University - St Louis

UMC of Southern Nevada

Lenox Hill Hospital