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Reducing Lung CongestIon Symptoms in Advanced Heart Failure

NCT03499236 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 605

Last updated 2025-08-19

No results posted yet for this 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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • V-Wave Ltd

    lead INDUSTRY

Principal Investigators

  • Stefan D Anker, MD, PhD · University Medical Center Gottingen, Germany

  • JoAnn Lindenfeld, MD · Vanderbilt University

  • Josep Rodés-Cabau, MD · Université Laval (CRIUCPQ-ULaval)

  • Gregg W Stone, MD · Colombia University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-19
Primary Completion
2023-10-09
Completion
2027-10-31
FDA Device
Yes

Countries

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

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03499236 on ClinicalTrials.gov