Reducing Lung CongestIon Symptoms in Advanced Heart Failure

NCT03499236 · tracked via the Priya Life Science USA tracker

Sponsor

V-Wave Ltd

Phase

Not applicable

Started

2018-09-19

Last updated

2025-08-19

Condition(s) studied

Heart Failure

Investigational drug(s) / intervention(s)

V-Wave Interatrial ShuntControl

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.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

99 Years

Healthy volunteers

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

Primary outcome measure(s)

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
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

Trial sites (83)

Facility	City	Region
Abrazo Arizona Heart Hospital	Phoenix	Arizona
Arizona Heart Rhythm Center	Phoenix	Arizona
Scripps Health	La Jolla	California
Long Beach Memorial Medical Center	Long Beach	California
Keck Medical Center of USC	Los Angeles	California
Cedars Sinai Medical Center	Los Angeles	California
Kaiser Permanente San Francisco	San Francisco	California
University of California, San Francisco	San Francisco	California
Stanford Hospital	Stanford	California
Los Robles Hospital & Medical Center	Thousand Oaks	California
The Lundquist Institute (Harbor-UCLA) Medical Center	Torrance	California
South Denver Cardiology	Littleton	Colorado
Memorial Hospital	Jacksonville	Florida
University of Miami	Miami	Florida
First Coast Cardiovascular Institute	Orange Park	Florida
Piedmont Hospital	Atlanta	Georgia
Northeast Georgia Medical Center	Gainesville	Georgia
Rush University Medical Center	Chicago	Illinois
Midwest Cardiovascular Institute	Naperville	Illinois
St Elizabeth Medical Center	Edgewood	Kentucky
United Heart & Vascular Clinic	Saint Paul	Minnesota
Nebraska Heart Institute	Lincoln	Nebraska
Valley Health System	Ridgewood	New Jersey
Weill Cornell	New York	New York
Rochester General Health System	Rochester	New York
Mission Hospital	Asheville	North Carolina
North Carolina Heart & Vascular	Raleigh	North Carolina
Summa Health	Akron	Ohio
Lindner Center for Research and Education at The Christ Hospital	Cincinnati	Ohio
Cleveland Clinic	Cleveland	Ohio
The Ohio State University	Columbus	Ohio
Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania
UPMC Pinnacle / Pinnacle Health Cardiovascular Institute	Wormleysburg	Pennsylvania
Medical University of South Carolina	Charleston	South Carolina
Centennial Medical Center	Nashville	Tennessee
Austin Heart	Austin	Texas
Baylor College of Medicine	Houston	Texas
Texas Heart Institute	Houston	Texas
University of Texas Memorial Hermann	Houston	Texas
Methodist Hospital	San Antonio	Texas

+ 43 more sites — see the full list on the official registry below.

More V-Wave Ltd trials in the USA

Reducing Right Ventricular Failure in Pulmonary Arterial Hypertension (RELIEVE-PAH) Active, not recruiting

Other trials for the same condition

Assessment of Safety and Accuracy of the Microtech System in Patients Undergoing Left Ventricular Assist Device Implantation Active, not recruiting

Alleviant ALLAY-HFrEF Study Recruiting

A Research Study to Look at How Well NNC0487-0111 Works Compared to Placebo in People With Heart Failure and Obesity Recruiting

Barostim-Enabled NEurohormonal Intervention For Improving Treatment of Heart Failure Recruiting

Cardiovascular Kidney and Metabolic Health Assessment and Patient Empowerment Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03499236 on ClinicalTrials.gov ↗ ← All trials in the USA