Reducing Lung CongestIon Symptoms in Advanced Heart Failure
NCT ID: NCT03499236
Last Updated: 2025-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
605 participants
INTERVENTIONAL
2018-09-19
2027-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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
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
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.
Control
Right heart catheterization, invasive echocardiography.
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
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Presence of Intracardiac thrombus
* Pulmonary hypertension with PASP of ≥70 mm/Hg or PVR \> 4 WU
* Significant RV dysfunction - TAPSE \<12mm or RVFAC ≤25%
* Left Ventricular End-Diastolic Diameter (LVEDD) \>8cm
* Moderate to severe aortic or mitral stenosis
* Stroke or TIA or DVT within the last 6 months
* eGFR \<25 ml/min/1.73 m\^2
* Anatomical anomaly on TEE or ICE that precludes implantation of Shunt across fossa ovalis (FO) of the interatrial septum
* Inadequate vascular access for implantation of shunt, e.g. femoral venous access for transseptal catheterization and inferior vena cava (IVC) is not patent
18 Years
99 Years
ALL
No
Sponsors
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V-Wave Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Stefan D Anker, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Gottingen, Germany
JoAnn Lindenfeld, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University
Josep Rodés-Cabau, MD
Role: PRINCIPAL_INVESTIGATOR
Université Laval (CRIUCPQ-ULaval)
Gregg W Stone, MD
Role: PRINCIPAL_INVESTIGATOR
Colombia University Medical Center
Locations
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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
Countries
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References
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Zile MR, Abraham WT, Lindenfeld J, Anker SD, Rodes-Cabau J, Pfeiffer MP, Boehmer JP, Litwin S, Baicu CF, Villota JN, Lee EC, Holcomb R, O'Keefe P, Eigler NL, Stone GW; RELIEVE-HF Investigators. Mechanistic Basis for Differential Effects of Interatrial Shunt Treatment in HFrEF vs HFpEF: The RELIEVE-HF Trial. JACC Cardiovasc Imaging. 2025 Sep 15:S1936-878X(25)00467-X. doi: 10.1016/j.jcmg.2025.08.005. Online ahead of print.
Stone GW, Lindenfeld J, Rodes-Cabau J, Anker SD, Zile MR, Kar S, Holcomb R, Pfeiffer MP, Bayes-Genis A, Bax JJ, Bank AJ, Costanzo MR, Verheye S, Roguin A, Filippatos G, Nunez J, Lee EC, Laufer-Perl M, Moravsky G, Litwin SE, Prihadi E, Gada H, Chung ES, Price MJ, Thohan V, Schewel D, Kumar S, Kische S, Shah KS, Donovan DJ, Zhang Y, Eigler NL, Abraham WT; RELIEVE-HF Investigators. Interatrial Shunt Treatment for Heart Failure: The Randomized RELIEVE-HF Trial. Circulation. 2024 Dec 10;150(24):1931-1943. doi: 10.1161/CIRCULATIONAHA.124.070870. Epub 2024 Sep 23.
Other Identifiers
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CL7018
Identifier Type: -
Identifier Source: org_study_id
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