NCT03838445

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

RELIEVE-PAH TRIAL: REducing Right ventricuLar faIlure With thE V-waVe Shunt in Pulmonary Arterial Hypertension

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: V-Wave Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a multi-national, multi-center, prospective, non-randomized, open label trial of patients implanted with the study device. A total of up to 20 patients will be implanted with the study device and followed at regular intervals for 1 year and then annually for a total of 5 years post implant.

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-02-14
• Primary completion: 2026-06-30
• Completion: 2031-12-31
• First posted: 2019-02-12
• Last updated: 2026-03-31

Locations

5 sites across 3 countries: United States, Canada, Mexico

Regulatory

• FDA-regulated device study