New heart valve device offers hope for patients with congenital defects

NCT ID NCT03441971

Ongoing Disease control Sponsor: W.L.Gore & Associates Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a new device called the GORE PV1 to replace the pulmonary valve and rebuild the right ventricular outflow tract in people with congenital heart defects. The device is designed to improve blood flow from the heart to the lungs. The study includes 15 participants aged 5 and older and will check safety and how well the device works at 6 months after the procedure.

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Conditions

The condition(s) this trial relates to.

congenital heart disease pulmonary valve insufficiency pulmonary valve stenosis tetralogy of fallot

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HEART DEFECTS, CONGENITAL PULMONARY VALVE INSUFFICIENCY PULMONARY VALVE STENOSIS TETRALOGY OF FALLOT

Contacts and locations

Locations

Boston Children's Hospital

Boston, Massachusetts, 02115, United States
Lurie Children's Hospital

Chicago, Illinois, 60611, United States
Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

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