MedTrace Logo

Reducing Right Ventricular Failure in Pulmonary Arterial Hypertension (RELIEVE-PAH)

NCT03838445 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-03-31

No results posted yet for this study

Summary

The objectives of the RELIEVE-PAH study are to obtain first-in-human experience with the study device in patients with severe pulmonary arterial hypertension, including evidence of initial safety, device performance and possible signals of clinical effectiveness.

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 ovals and straddles the interatrial septum.

Sponsors & Collaborators

  • V-Wave Ltd

    lead INDUSTRY

Principal Investigators

  • Victor Tapson, M.D. · Cedars-Sinai Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-14
Primary Completion
2026-06-30
Completion
2031-12-31
FDA Device
Yes

Countries

  • United States
  • Canada
  • Mexico

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 NCT03838445 on ClinicalTrials.gov