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Clinical Trials in the Netherlands / NCT03499236
Active, not recruiting Not applicable

Reducing Lung CongestIon Symptoms in Advanced Heart Failure

NCT03499236 · tracked via the Priya Life Science Netherlands 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
No
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)

FacilityCityRegionStatus
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.

Other trials for the same condition

Cardiac Resynchronization Therapy in Previously Untreatable and High Risk Upgrade Patients Active, not recruiting
Investigating the Impact of Nudging Cardiologists to Prescribe Guideline-directed Medical Therapy in Heart Failure Patients Enrolling by invitation
Neural Cardiac Therapy for Heart Failure Study (NECTAR-HF) Active, not recruiting
Atrial Fibrillation Ablation Versus Atrioventricular Nodal Ablation with Conduction System Pacing in Heart Failure Recruiting
Explainable AI for Predicting Hospital Admissions in Heart Failure: ExplAIn-HF Enrolling by invitation
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 Netherlands