Reducing Lung CongestIon Symptoms in Advanced Heart Failure
RELIEVE-HF
RELIEVE-HF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure
1 other identifier
interventional
605
11 countries
83
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable heart-failure
Started Sep 2018
Longer than P75 for not_applicable heart-failure
83 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 29, 2018
CompletedFirst Posted
Study publicly available on registry
April 17, 2018
CompletedStudy Start
First participant enrolled
September 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 9, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2027
ExpectedAugust 19, 2025
November 1, 2024
5.1 years
March 29, 2018
August 18, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Safety-Percentage of Treatment patients experiencing major device-related adverse events
Percentage of Treatment group patients experiencing any device-related Major Adverse Cardiovascular or Neurological Events (MACNE) during the first 30-days after randomization, compared to a pre-specified Performance Goal
30-days after randomization
Effectiveness-Hierarchical composite of death, heart transplant or left ventricular assist device (LVAD) implantation, HF hospitalizations, worsening HF events treated as an outpatient, and change in Kansas City Cardiomyopathy Questionnaire (KCCQ)
Treatment and Control groups will be compared using the Finkelstein-Schoenfeld method
Follow-up duration at endpoint analysis ranges from a minimum of 12 to a maximum of 24 months
Secondary Outcomes (8)
6MWT changes
Baseline to 12 months
KCCQ changes
Baseline to 12 months
KCCQ changes
Baseline through study completion, maximum of five years
Time to all-cause death, LVAD/Transplant, or heart failure hospitalization
Baseline through study completion, maximum of five years
Time to all-cause death or first heart failure hospitalization
Baseline through study completion, maximum of five years
- +3 more secondary outcomes
Study Arms (3)
Treatment
EXPERIMENTALTreatment 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
Control
OTHERControl 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.
Roll in
EXPERIMENTALRoll 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
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Systolic blood pressure \<90 or \>160 mmHg
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- V-Wave Ltdlead
Study Sites (83)
Abrazo Arizona Heart Hospital
Phoenix, Arizona, 85016, United States
Arizona Heart Rhythm Center
Phoenix, Arizona, 85016, United States
Scripps Health
La Jolla, California, 92037, United States
Long Beach Memorial Medical Center
Long Beach, California, 90806, United States
Keck Medical Center of USC
Los Angeles, California, 90033, United States
Cedars Sinai Medical Center
Los Angeles, California, 90211, United States
Kaiser Permanente San Francisco
San Francisco, California, 94118, United States
University of California, San Francisco
San Francisco, California, 94143, United States
Stanford Hospital
Stanford, California, 94305, United States
Los Robles Hospital & Medical Center
Thousand Oaks, California, 91360, United States
The Lundquist Institute (Harbor-UCLA) Medical Center
Torrance, California, 90502, United States
South Denver Cardiology
Littleton, Colorado, 80120, United States
Memorial Hospital
Jacksonville, Florida, 32216, United States
University of Miami
Miami, Florida, 33136, United States
First Coast Cardiovascular Institute
Orange Park, Florida, 32003, United States
Piedmont Hospital
Atlanta, Georgia, 30309, United States
Northeast Georgia Medical Center
Gainesville, Georgia, 30501, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Midwest Cardiovascular Institute
Naperville, Illinois, 60540, United States
St Elizabeth Medical Center
Edgewood, Kentucky, 41017, United States
United Heart & Vascular Clinic
Saint Paul, Minnesota, 55102, United States
Nebraska Heart Institute
Lincoln, Nebraska, 68526, United States
Valley Health System
Ridgewood, New Jersey, 07450, United States
Weill Cornell
New York, New York, 10065, United States
Rochester General Health System
Rochester, New York, 14621, United States
Mission Hospital
Asheville, North Carolina, 28801, United States
North Carolina Heart & Vascular
Raleigh, North Carolina, 27607, United States
Summa Health
Akron, Ohio, 44304, United States
Lindner Center for Research and Education at The Christ Hospital
Cincinnati, Ohio, 45219, United States
Cleveland Clinic
Cleveland, Ohio, 80120, United States
The Ohio State University
Columbus, Ohio, 43210, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
UPMC Pinnacle / Pinnacle Health Cardiovascular Institute
Wormleysburg, Pennsylvania, 17043, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Centennial Medical Center
Nashville, Tennessee, 37203, United States
Austin Heart
Austin, Texas, 78756, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Texas Heart Institute
Houston, Texas, 77030, United States
University of Texas Memorial Hermann
Houston, Texas, 77030, United States
Methodist Hospital
San Antonio, Texas, 78249, United States
Christus Mother Frances Hospital
Tyler, Texas, 75701, United States
University of Utah Hospital
Salt Lake City, Utah, 84132, United States
Chippenham Medical Center
Richmond, Virginia, 23225, United States
St. Vincent's Hospital Sydney
Darlinghurst, New South Wales, 2010, 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, G1V 4G5, Canada
Charité - Universitätsmedizin Berlin Campus Virchow-Klinikum
Berlin, 10117, Germany
Vivantes Klinikum im Friedrichshain
Berlin, 10249, Germany
Vivantes Klinikum Urban
Berlin, Germany
Marienkrankrankenhas
Hamburg, Germany
Universitätsklinikum Leipzig
Leipzig, 04103, Germany
Herzzentrum Leipzig
Leipzig, 04289, Germany
Ludwig-Maximilians-Universität München
München, 81377, Germany
SANA Remscheid
Remscheid, Germany
University of Rostock
Rostock, Germany
University Hospital Samson Assuta Ashdod
Ashdod, 7747629, Israel
Yitzhak Shamir Medical Center
Be’er Ya‘aqov, Israel
Hadassah Medical Center
Jerusalem, Israel
The Chaim Sheba Medical Center Tel-Hashomer
Ramat Gan, 52621, Israel
Kaplan Medical Center
Rehovot, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
The Baruch Padeh Medical Center, Poriya
Tiberias, 15208, Israel
St Antonius Ziekenhuis Nieuwegein
Nieuwegein, Utrecht, 3435, Netherlands
Academic Medical Center, The Netherlands
Amsterdam, 1105, Netherlands
Erasmus University Medical Center Rotterdam
Rotterdam, 3015, 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, 08036, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041, Spain
Hospital Universitari Germans Trias i Pujol, Badalona Barcelona
Barcelona, 08916, Spain
Hospital Clínico San Carlos
Madrid, 28040, Spain
Hospital Puerta de Hierro-Majadahonda
Madrid, 28222, Spain
Hospital Clínico Universitario de Valencia
Valencia, 46010, Spain
Hospital Clínico Universitario de Valladolid
Valladolid, 47003, Spain
Bern University Hospital
Bern, 3010, Switzerland
University Hospital of Zürich
Zurich, 8091, Switzerland
Related Publications (2)
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. 2026 Jan;19(1):1-15. doi: 10.1016/j.jcmg.2025.08.005. Epub 2025 Sep 15.
PMID: 40892630DERIVEDStone 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.
PMID: 39308371DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stefan D Anker, MD, PhD
University Medical Center Gottingen, Germany
- PRINCIPAL INVESTIGATOR
JoAnn Lindenfeld, MD
Vanderbilt University
- PRINCIPAL INVESTIGATOR
Josep Rodés-Cabau, MD
Université Laval (CRIUCPQ-ULaval)
- PRINCIPAL INVESTIGATOR
Gregg W Stone, MD
Colombia University Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- In the randomized cohort, participants, the clinical team, and research staff managing the patient after randomization will be blinded to study assignment.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 29, 2018
First Posted
April 17, 2018
Study Start
September 19, 2018
Primary Completion
October 9, 2023
Study Completion (Estimated)
October 31, 2027
Last Updated
August 19, 2025
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share