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ACTIVE NOT RECRUITING
NCT03499236
NA

Reducing Lung CongestIon Symptoms in Advanced Heart Failure

Sponsor: V-Wave Ltd

View on ClinicalTrials.gov

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

DEVICE

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.

OTHER

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