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Evaluation of the GORE PV1 Device in Patients With Pulmonary Valve Dysfunction

Active, not recruiting · Not applicable · NCT03441971

Conditions: Heart Defects, Congenital, Tetralogy of Fallot, Pulmonary Valve Insufficiency, Pulmonary Valve Stenosis

At a glance

Research payments reported, 2025
$16,830
U.S. investigators named
0
Sites paid
2
Planned or actual enrollment
15

About the trial

Sponsor
W.L.Gore & Associates
Tested
GORE PV1 (device)
Dates
Started 2018-06-07; completion 2030-03
Results posted
Not yet

This study will assess the safety and performance of the GORE PV1 Device for replacement of the pulmonary valve and reconstruction of the Right Ventricular Outflow Tract (RVOT).

From ClinicalTrials.gov, last updated 2026-02-05. Full record, eligibility and contacts (opens in a new tab)

Industry funding

W. L. Gore & Associates, Inc. reported $16,830 in research payments for this study in 2025 (2 payments).

Products named: Product in Development

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.

Sites paid to run it

Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.