RELIEVE-HF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure
Status: Active_not_recruiting
Location: See all (92) locations...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The objective of the RELIEVE-HF study is to provide reasonable assurance of safety and effectiveness of the V-Wave Interatrial Shunt System by improving meaningful clinical outcomes in patients with New York Heart Association (NYHA) functional Class II, Class III, or ambulatory Class IV heart failure (HF), irrespective of left ventricular ejection fraction, who at baseline are treated with guideline-directed drug and device therapies.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:
• Both heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF) patients
• NYHA Class II, Class III, or ambulatory Class IV HF
• Receiving guideline directed medical and device therapy (GDMT) for heart failure
• For NYHA Class III and ambulatory Class IV, at least one prior hospitalization for heart failure within the last year or elevated BNP level of at least 300 pg/ml or NT-proBNP level of at least 1,500 pg/ml. BNP/NT-ProBNP levels corrected for BMI
• For NYHA Class II, must have both hospitalization and elevated BNP levels as above specifications
Locations
United States
Arizona
Abrazo Arizona Heart Hospital
Phoenix
Arizona Heart Rhythm Center
Phoenix
California
Scripps Health
La Jolla
Long Beach Memorial Medical Center
Long Beach
Cedars Sinai Medical Center
Los Angeles
Keck Medical Center of USC
Los Angeles
Kaiser Permanente San Francisco
San Francisco
University of California, San Francisco
San Francisco
Stanford Hospital
Stanford
Los Robles Hospital & Medical Center
Thousand Oaks
The Lundquist Institute (Harbor-UCLA) Medical Center
Torrance
Colorado
South Denver Cardiology
Littleton
Florida
Memorial Hospital
Jacksonville
University of Miami
Miami
First Coast Cardiovascular Institute
Orange Park
Georgia
Piedmont Hospital
Atlanta
Northeast Georgia Medical Center
Gainesville
Illinois
Rush University Medical Center
Chicago
Midwest Cardiovascular Institute
Naperville
Kentucky
St Elizabeth Medical Center
Edgewood
Minnesota
United Heart & Vascular Clinic
Saint Paul
North Carolina
Mission Hospital
Asheville
North Carolina Heart & Vascular
Raleigh
Nebraska
Nebraska Heart Institute
Lincoln
New Jersey
Valley Health System
Ridgewood
New York
Northwell Health Lenox Hill Hospital
New York
Weill Cornell
New York
Rochester General Health System
Rochester
Ohio
Summa Health
Akron
Lindner Center for Research and Education at The Christ Hospital
Cincinnati
Cleveland Clinic
Cleveland
The Ohio State University
Columbus
Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey
UPMC Pinnacle / Pinnacle Health Cardiovascular Institute
Wormleysburg
South Carolina
Medical University of South Carolina
Charleston
Tennessee
Centennial Medical Center
Nashville
Texas
Austin Heart
Austin
Baylor College of Medicine
Houston
Texas Heart Institute
Houston
University of Texas Memorial Hermann
Houston
Methodist Hospital
San Antonio
Christus Mother Frances Hospital
Tyler
Utah
University of Utah Hospital
Salt Lake City
Virginia
Chippenham Medical Center
Richmond
Other Locations
Australia
Flinders Medical Centre
Adelaide
Prince Charles Hospital
Brisbane
St. Vincent's Hospital Sydney
Darlinghurst
St. Vincent's Hospital
Melbourne
Epworth Hospital
Richmond
Belgium
Ziekenhuis Aan De Stroom vzw (ZAS)
Antwerp
AZ Sint-Jan Brugge
Brugge
Canada
Montréal Heart Institute
Montréal
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
Québec
Germany
Charité - Universitätsmedizin Berlin Campus Virchow-Klinikum
Berlin
Vivantes Klinikum im Friedrichshain
Berlin
Vivantes Klinikum Urban
Berlin
Marienkrankrankenhas
Hamburg
Herzzentrum Leipzig
Leipzig
Universitätsklinikum Leipzig
Leipzig
Universitatsmedizin Mainz
Mainz
Ludwig-Maximilians-Universität München
München
SANA Remscheid
Remscheid
University of Rostock
Rostock
Israel
University Hospital Samson Assuta Ashdod
Ashdod
Yitzhak Shamir Medical Center
Be'er Ya'aqov
Soroka University Medical Center
Beer-sheva
Rambam Medical Center
Haifa
Hadassah Medical Center
Jerusalem
Shaare Zedek Medical Center
Jerusalem
The Chaim Sheba Medical Center Tel-Hashomer
Ramat Gan
Kaplan Medical Center
Rechovot
Tel Aviv Sourasky Medical Center
Tel Aviv
The Baruch Padeh Medical Center, Poriya
Tiberias
Netherlands
Academic Medical Center, The Netherlands
Amsterdam
St Antonius Ziekenhuis Nieuwegein
Nieuwegein
Erasmus University Medical Center Rotterdam
Rotterdam
New Zealand
Christchurch Hospital
Christchurch
Auckland Hospital
Grafton
Poland
Górnośląskie Centrum Medyczne, Uniwersytetu Medycznego w Katowicach
Katowice
Institute of Cardiology, Warsaw
Warszawa
The 4th Military Clinical Hospital Wroclaw
Wrocław
University Hospital Wroclaw
Wrocław
Spain
Hospital Clinic of Barcelona
Barcelona
Hospital de la Santa Creu i Sant Pau
Barcelona
Hospital Universitari Germans Trias i Pujol, Badalona Barcelona
Barcelona
Hospital Clínico San Carlos
Madrid
Hospital Puerta de Hierro-Majadahonda
Madrid
University Hospital Virgen de la Arrixaca
Murcia
Hospital Clínico Universitario de Valencia
Valencia
Hospital Clínico Universitario de Valladolid
Valladolid
Switzerland
Bern University Hospital
Bern
University Hospital of Zürich
Zürich
Time Frame
Start Date: 2018-09-19
Completion Date: 2027-10-31
Participants
Target number of participants: 605
Treatments
Experimental: Treatment
Treatment arm patients will undergo a diagnostic right heart catheterization and invasive echocardiography to determine study eligibility followed by transseptal catheterization and V-Wave Shunt implantation
Other: Control
Control arm patients will undergo a diagnostic right heart catheterization and invasive echocardiography to determine study eligibility, but will not have transseptal catheterization or shunt implantation.
Experimental: Roll in
Roll in arm patients will undergo a diagnostic right heart catheterization and invasive echocardiography to determine study eligibility followed by transseptal catheterization and V-Wave Shunt implantation
Authors
Jon Resar, Gautam Kumar, Srinivasa Potluri, Louis Salvaggio, Brijeshwar Maini, Nabil Dib, Hilmi Alnsasra, Robert J. Widmer, Wayne Batchelor, Daniel Donovan, Don Chomsky, Varinder Singh, Ajith Nair, Zvonimir Krajcer, Rajeev Singh, Hemal Gada, George Petrossian, John Boehmer, Ugochukwu Egolum, David M Shavelle, Daniel Dumitrescu, Burkhard Sievers, David Prior, Pranav Kansara, Peter Bittenbender, Yee Weng Wong, Rob Doughty, Sonia Mirabet, Luis Nombela, Richard Troughton, Eugene Kotlyar, Reda Ibrahim, Jan Van Der Heyden, Ian Buysschaert, Oren Caspi, Prof. Wojciech Wojakowski, Dariusz Dudek, Eric Horlick, Jacek Legutko, Carmine De Pasquale
Related Therapeutic Areas
Sponsors
Leads: V-Wave Ltd