Reducing Lung CongestIon Symptoms in Advanced Heart Failure
- Conditions
- Heart Failure
- Interventions
- Device: V-Wave Interatrial ShuntOther: Control
- Registration Number
- NCT03499236
- Lead Sponsor
- V-Wave Ltd
- 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.
- Detailed Description
This is a prospective, multi-center, 1:1 randomized, patient and observer blinded clinical study, with a Shunt Treatment arm and a non-implant Control arm. A total of approximately 500 patients will be randomized. Patients and all research staff managing the patients after randomization will be blinded during follow-up for a minimum of 12 months to a maximum of 24 months. Control patients will have the opportunity to receive a shunt after 24 months once unblinding occurs, if they provide consent, and continue to meet inclusion/exclusion criteria. All implanted patients will be followed for a total of 5 years from the time of the study device implantation.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 605
- 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
Main
- 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
- Hemodynamic heart rhythm, or respiratory instability at time of Final Exclusion Criteria
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment V-Wave Interatrial Shunt 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 Control 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. Roll in V-Wave Interatrial Shunt 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
- Primary Outcome Measures
Name Time Method 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) Follow-up duration at endpoint analysis ranges from a minimum of 12 to a maximum of 24 months Treatment and Control groups will be compared using the Finkelstein-Schoenfeld method
Safety-Percentage of Treatment patients experiencing major device-related adverse events 30-days after randomization 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
- Secondary Outcome Measures
Name Time Method KCCQ changes Baseline through study completion, maximum of five years KCCQ changes
Time to all-cause death, LVAD/Transplant, or heart failure hospitalization Baseline through study completion, maximum of five years Time to all-cause death, LVAD/Transplant, or heart failure hospitalization
Cumulative heart failure hospitalizations Baseline through study completion, maximum of five years Cumulative heart failure hospitalizations
Time to all-cause death or first heart failure hospitalization Baseline through study completion, maximum of five years Time to all-cause death or first heart failure hospitalization
Time to first heart failure hospitalization Baseline through study completion, maximum of five years Time to first heart failure hospitalization
Modified Primary Effectiveness Endpoint including all-cause death, LVAD/Transplant, HF Hospitalizations, and worsening HF events treated as outpatient but without KCCQ Baseline through study completion, maximum of five years Modified Primary Effectiveness Endpoint including all-cause death, LVAD/Transplant, HF Hospitalizations, and worsening HF events treated as outpatient but without KCCQ
6MWT changes Baseline to 12 months 6MWT changes
Trial Locations
- Locations (92)
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
Soroka University Medical Center
🇮🇱Beer-Sheva, Israel
Rambam Medical Center
🇮🇱Haifa, Israel
Shaare Zedek Medical Center
🇮🇱Jerusalem, Israel
Hadassah Medical Center
🇮🇱Jerusalem, Israel
The Chaim Sheba Medical Center Tel-Hashomer
🇮🇱Ramat Gan, Israel
Kaplan Medical Center
🇮🇱Rechovot, 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
Auckland Hospital
🇳🇿Grafton, New Zealand
Górnośląskie Centrum Medyczne, Uniwersytetu Medycznego w Katowicach
🇵🇱Katowice, Poland
Institute of Cardiology, Warsaw
🇵🇱Warszawa, Poland
Valley Health System
🇺🇸Ridgewood, New Jersey, United States
Weill Cornell
🇺🇸New York, New York, United States
Northwell Health Lenox Hill Hospital
🇺🇸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
Epworth Hospital
🇦🇺Richmond, Australia
AZ Sint-Jan Brugge
🇧🇪Brugge, Belgium
Montréal Heart Institute
🇨🇦Montréal, 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
Universitatsmedizin Mainz
🇩🇪Mainz, Germany
Ziekenhuis Aan De Stroom vzw (ZAS)
🇧🇪Antwerp, Belgium
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
The 4th Military Clinical Hospital Wroclaw
🇵🇱Wrocław, Poland
University Hospital Wroclaw
🇵🇱Wrocław, 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
University Hospital Virgen de la Arrixaca
🇪🇸Murcia, Spain
Hospital Clínico Universitario de Valencia
🇪🇸Valencia, Spain
Hospital Clínico Universitario de Valladolid
🇪🇸Valladolid, Spain
Bern University Hospital
🇨🇭Bern, Switzerland
University Hospital of Zürich
🇨🇭Zürich, Switzerland
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