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RELIEVE-PAH Study: V-Wave Interatrial Shunt for Pulmonary Arterial Hypertension

This study, called RELIEVE-PAH, is testing a new device called the V-Wave Interatrial Shunt System for people with severe pulmonary arterial hypertension (PAH). PAH is a type of high blood pressure in the arteries of the lungs. The shunt is a permanent implant placed during a minimally invasive heart procedure. The study aims to see if the device is safe, works as intended, and shows any early signs of helping patients. You might be able to join if you are an adult with Group 1 PAH and have severe symptoms (WHO Functional Class III or IV). The study will look at how many patients have device-related problems or other major issues, and if the device can be successfully implanted. The current status of the study is unclear, and it plans to enroll up to 9 participants.

Study design
This is a multi-national, multi-center study that is not randomized and is open-label, meaning everyone knows what treatment is being given. It plans to enroll up to 20 patients in total.
What's involved
Participants will have the V-Wave Interatrial Shunt System implanted and will be followed at regular intervals for 1 year.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed annually for a total of 5 years after the implant.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03838445

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

Active, Not Recruiting
NAAges 18+InterventionalTreatment
V-Wave Ltd
~9 participants
Updated 2026-06-22 on ClinicalTrials.gov
What's tested:V-Wave Interatrial Shunt

At a glance

Recruiting sites
0 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety-Percentage of Treatment patients experiencing major device-related adverse events
Measured over 3 months
+3 more outcomes measured

Conditions

Pulmonary Arterial Hypertension

Explore related trials

Pulmonary Arterial Hypertension

NCT03838445

Where you'd take part

This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Instituto Nacional de Cardiologia

    Mexico City, Mexicono site contact published

  • Keck Medical Center of USC

    Los Angeles, Californiano site contact published

  • University of California, San Francisco

    San Francisco, Californiano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

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

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

What this trial measures

  • Safety-Percentage of Treatment patients experiencing major device-related adverse events3 months

    Percentage of Treatment group patients experiencing any device-related Major Adverse Cardiovascular or Neurological Events (MACNE) during the first 90-days after implantation

  • Safety-Percentage of Treatment patients experiencing any major adverse event3 months

    Percentage of Treatment group patients experiencing any Major Adverse Cardiovascular or Neurological Events (MACNE) during the first 90-days after implantation

  • Procedure Success-Percentage of patients successfully implanted with study device3 months

    Percentage of patients successfully implanted with the study device at the intended location across the interatrial septum during the index procedure compared to patients with attempted implantations

  • Device Success-Percentage of patients implanted with right to left interatrial flow3 months

    Percentage of patients successfully implanted with the study device with right to left interatrial flow on echocardiography at 3 months