RecruitingNot ApplicableNCT03838445

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


Sponsor

V-Wave Ltd

Enrollment

20 participants

Start Date

Feb 14, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a small device implanted in the wall between the two upper chambers of the heart (an interatrial shunt) can reduce the dangerous strain on the right side of the heart in patients with severe pulmonary arterial hypertension — a condition where blood pressure in the lungs is dangerously high. **You may be eligible if...** - You have been diagnosed with Group 1 pulmonary arterial hypertension (PAH), which includes idiopathic (unknown cause), connective tissue disease–related, HIV-related, or congenital heart disease–related PAH - Your symptoms are severe (WHO Functional Class III or IV) despite being on maximum available medication for at least 3 months - You meet specific risk criteria from the 2015 European heart guidelines **You may NOT be eligible if...** - Your oxygen levels drop below 90% at rest without supplemental oxygen - The pressure in the right side of your heart is very high (mean right atrial pressure above 20 mmHg) - You have severe lung disease - You have significant failure of organs other than the right side of your heart - Your left heart function is significantly reduced (ejection fraction below 40%) - The anatomy of your heart does not allow the device to be safely implanted - Your blood vessels cannot accommodate the catheter needed to implant the device Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEV-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.


Locations(5)

Keck Medical Center of USC

Los Angeles, California, United States

University of California, San Francisco

San Francisco, California, United States

The Ohio State University Wexner Medical Center - Davis Heart & Lung Research Institute

Columbus, Ohio, United States

Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval

Québec, Canada

Instituto Nacional de Cardiologia

Mexico City, Mexico

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NCT03838445


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