Reducing Lung CongestIon Symptoms in Advanced Heart Failure

Heart Failure Clinical Trial

— RELIEVE-HF  

Official title:

RELIEVE-HF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03499236
• Other study ID #: CL7018
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 19, 2018
• Est. completion date: October 31, 2027

Study information

• Verified date: November 2023
• Source: V-Wave Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 605
• Est. completion date: October 31, 2027
• Est. primary completion date: October 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Main Inclusion Criteria:

• 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 Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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

Country	Name	City	State
Australia	Flinders Medical Centre	Adelaide
Australia	Prince Charles Hospital	Brisbane
Australia	St. Vincent's Hospital Sydney	Darlinghurst	New South Wales
Australia	St. Vincent's Hospital	Melbourne
Australia	Epworth Hospital	Richmond
Belgium	Antwerp Cardiovascular Center, ZNA Middelheim Hospital	Antwerp
Belgium	AZ Sint-Jan Brugge	Brugge
Canada	Montréal Heart Institute	Montréal
Canada	Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval	Québec
Canada	Toronto General Hospital	Toronto	Ontario
Germany	Charité - Universitätsmedizin Berlin Campus Virchow-Klinikum	Berlin
Germany	Vivantes Klinikum im Friedrichshain	Berlin
Germany	Vivantes Klinikum Urban	Berlin
Germany	Marienkrankrankenhas	Hamburg
Germany	Herzzentrum Leipzig	Leipzig
Germany	Universitätsklinikum Leipzig	Leipzig
Germany	Universitatsmedizin Mainz	Mainz
Germany	Ludwig-Maximilians-Universität München	München
Germany	SANA Remscheid	Remscheid
Germany	University of Rostock	Rostock
Israel	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	Hadassah Medical Center	Jerusalem
Israel	Shaare Zedek 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
Netherlands	Academic Medical Center, The Netherlands	Amsterdam
Netherlands	St Antonius Ziekenhuis Nieuwegein	Nieuwegein	Utrecht
Netherlands	Erasmus University Medical Center Rotterdam	Rotterdam
New Zealand	Christchurch Hospital	Christchurch
New Zealand	Auckland Hospital	Grafton
Poland	Górnoslaskie Centrum Medyczne, Uniwersytetu Medycznego w Katowicach	Katowice
Poland	Institute of Cardiology, Warsaw	Warszawa
Poland	The 4th Military Clinical Hospital Wroclaw	Wroclaw
Poland	University Hospital Wroclaw	Wroclaw
Spain	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
Switzerland	Bern University Hospital	Bern
Switzerland	University Hospital of Zürich	Zürich
United States	Summa Health	Akron	Ohio
United States	Mission Hospital	Asheville	North Carolina
United States	Piedmont Hospital	Atlanta	Georgia
United States	Austin Heart	Austin	Texas
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	Advocate Illinois Masonic Medical Center	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	Lindner Center for Research and Education at The Christ Hospital	Cincinnati	Ohio
United States	Morton Plant Mease Healthcare	Clearwater	Florida
United States	Cleveland Clinic	Cleveland	Ohio
United States	The Ohio State University	Columbus	Ohio
United States	Atlanta VA Health System	Decatur	Georgia
United States	St. Francis Hospital	East Hills	New York
United States	St Elizabeth Medical Center	Edgewood	Kentucky
United States	Northeast Georgia Medical Center	Gainesville	Georgia
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Memorial Regional Hospital	Hollywood	Florida
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	Memorial Hospital	Jacksonville	Florida
United States	Scripps Health	La Jolla	California
United States	Nebraska Heart Institute	Lincoln	Nebraska
United States	South Denver Cardiology	Littleton	Colorado
United States	Long Beach Memorial Medical Center	Long Beach	California
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	Keck Medical Center of USC	Los Angeles	California
United States	University of Miami	Miami	Florida
United States	Advocate Health and Hospitals Corporation (Edwards Hospital)	Naperville	Illinois
United States	Centennial Medical Center	Nashville	Tennessee
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Northwell Health Lenox Hill Hospital	New York	New York
United States	Weill Cornell	New York	New York
United States	Sentara Heart Hospital	Norfolk	Virginia
United States	First Coast Cardiovascular Institute	Orange Park	Florida
United States	Abrazo Arizona Heart Hospital	Phoenix	Arizona
United States	Arizona Heart Rhythm Center	Phoenix	Arizona
United States	North Carolina Heart & Vascular	Raleigh	North Carolina
United States	Chippenham Medical Center	Richmond	Virginia
United States	Valley Health System	Ridgewood	New Jersey
United States	Rochester General Health System	Rochester	New York
United States	United Heart & Vascular Clinic	Saint Paul	Minnesota
United States	University of Utah Hospital	Salt Lake City	Utah
United States	Methodist Hospital	San Antonio	Texas
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	Baylor Heart and Vascular-Dallas (Scott and White) -Temple	Temple	Texas
United States	Los Robles Hospital & Medical Center	Thousand Oaks	California
United States	The Lundquist Institute (Harbor-UCLA) Medical Center	Torrance	California
United States	Christus Mother Frances Hospital	Tyler	Texas
United States	UPMC Pinnacle / Pinnacle Health Cardiovascular Institute	Wormleysburg	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
V-Wave Ltd

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Germany,  Israel,  Netherlands,  New Zealand,  Poland,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	6MWT changes	6MWT changes	Baseline to 12 months
Secondary	KCCQ changes	KCCQ changes	Baseline to 12 months
Secondary	KCCQ changes	KCCQ changes	Baseline through study completion, maximum of five years
Secondary	Time to all-cause death, LVAD/Transplant, or heart failure hospitalization	Time to all-cause death, LVAD/Transplant, or heart failure hospitalization	Baseline through study completion, maximum of five years
Secondary	Time to all-cause death or first heart failure hospitalization	Time to all-cause death or first heart failure hospitalization	Baseline through study completion, maximum of five years
Secondary	Cumulative heart failure hospitalizations	Cumulative heart failure hospitalizations	Baseline through study completion, maximum of five years
Secondary	Time to first heart failure hospitalization	Time to first heart failure hospitalization	Baseline through study completion, maximum of five years
Secondary	Modified Primary Effectiveness Endpoint including all-cause death, LVAD/Transplant, HF Hospitalizations, and worsening HF events treated as outpatient but without KCCQ	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