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Reducing Lung CongestIon Symptoms in Advanced Heart Failure
Sponsor: V-Wave Ltd
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.
Official title: RELIEVE-HF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure
Key Details
Gender
All
Age Range
18 Years - 99 Years
Study Type
INTERVENTIONAL
Enrollment
605
Start Date
2018-09-19
Completion Date
2027-10-31
Last Updated
2025-08-19
Healthy Volunteers
No
Conditions
Interventions
V-Wave Interatrial Shunt
The V-Wave Interatrial Shunt System, includes a permanent implant placed during a minimally invasive cardiac catheterization procedure using its dedicated Delivery Catheter. The device is implanted through the fossa ovalis and straddles the interatrial septum.
Control
Right heart catheterization, invasive echocardiography.
Locations (83)
Abrazo Arizona Heart Hospital
Phoenix, Arizona, United States
Arizona Heart Rhythm Center
Phoenix, Arizona, United States
Scripps Health
La Jolla, California, United States
Long Beach Memorial Medical Center
Long Beach, California, United States
Keck Medical Center of USC
Los Angeles, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Kaiser Permanente San Francisco
San Francisco, California, United States
University of California, San Francisco
San Francisco, California, United States
Stanford Hospital
Stanford, California, United States
Los Robles Hospital & Medical Center
Thousand Oaks, California, United States
The Lundquist Institute (Harbor-UCLA) Medical Center
Torrance, California, United States
South Denver Cardiology
Littleton, Colorado, United States
Memorial Hospital
Jacksonville, Florida, United States
University of Miami
Miami, Florida, United States
First Coast Cardiovascular Institute
Orange Park, Florida, United States
Piedmont Hospital
Atlanta, Georgia, United States
Northeast Georgia Medical Center
Gainesville, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Midwest Cardiovascular Institute
Naperville, Illinois, United States
St Elizabeth Medical Center
Edgewood, Kentucky, United States
United Heart & Vascular Clinic
Saint Paul, Minnesota, United States
Nebraska Heart Institute
Lincoln, Nebraska, United States
Valley Health System
Ridgewood, New Jersey, United States
Weill Cornell
New York, New York, United States
Rochester General Health System
Rochester, New York, United States
Mission Hospital
Asheville, North Carolina, United States
North Carolina Heart & Vascular
Raleigh, North Carolina, United States
Summa Health
Akron, Ohio, United States
Lindner Center for Research and Education at The Christ Hospital
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
UPMC Pinnacle / Pinnacle Health Cardiovascular Institute
Wormleysburg, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Centennial Medical Center
Nashville, Tennessee, United States
Austin Heart
Austin, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Texas Heart Institute
Houston, Texas, United States
University of Texas Memorial Hermann
Houston, Texas, United States
Methodist Hospital
San Antonio, Texas, United States
Christus Mother Frances Hospital
Tyler, Texas, United States
University of Utah Hospital
Salt Lake City, Utah, United States
Chippenham Medical Center
Richmond, Virginia, United States
St. Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia
Flinders Medical Centre
Adelaide, Australia
Prince Charles Hospital
Brisbane, Australia
St. Vincent's Hospital
Melbourne, Australia
Ziekenhuis Aan De Stroom vzw (ZAS)
Antwerp, Belgium
AZ Sint-Jan Brugge
Bruges, Belgium
Montréal Heart Institute
Montreal, Canada
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
Québec, Canada
Charité - Universitätsmedizin Berlin Campus Virchow-Klinikum
Berlin, Germany
Vivantes Klinikum im Friedrichshain
Berlin, Germany
Vivantes Klinikum Urban
Berlin, Germany
Marienkrankrankenhas
Hamburg, Germany
Universitätsklinikum Leipzig
Leipzig, Germany
Herzzentrum Leipzig
Leipzig, Germany
Ludwig-Maximilians-Universität München
München, Germany
SANA Remscheid
Remscheid, Germany
University of Rostock
Rostock, Germany
University Hospital Samson Assuta Ashdod
Ashdod, Israel
Yitzhak Shamir Medical Center
Be’er Ya‘aqov, Israel
Hadassah Medical Center
Jerusalem, Israel
The Chaim Sheba Medical Center Tel-Hashomer
Ramat Gan, Israel
Kaplan Medical Center
Rehovot, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
The Baruch Padeh Medical Center, Poriya
Tiberias, Israel
St Antonius Ziekenhuis Nieuwegein
Nieuwegein, Utrecht, Netherlands
Academic Medical Center, The Netherlands
Amsterdam, Netherlands
Erasmus University Medical Center Rotterdam
Rotterdam, Netherlands
Christchurch Hospital
Christchurch, New Zealand
Institute of Cardiology, Warsaw
Warsaw, Poland
The 4th Military Clinical Hospital Wroclaw
Wroclaw, Poland
University Hospital Wroclaw
Wroclaw, Poland
Hospital Clinic of Barcelona
Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Universitari Germans Trias i Pujol, Badalona Barcelona
Barcelona, Spain
Hospital Clínico San Carlos
Madrid, Spain
Hospital Puerta de Hierro-Majadahonda
Madrid, Spain
Hospital Clínico Universitario de Valencia
Valencia, Spain
Hospital Clínico Universitario de Valladolid
Valladolid, Spain
Bern University Hospital
Bern, Switzerland
University Hospital of Zürich
Zurich, Switzerland