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

Running, not enrolling · Not applicable

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

In brief

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).

Key facts

Study ID

NCT03441971

Run by

W.L.Gore & Associates

People needed

15

Starts

2018-06-07

Expected to finish

2030-03-01

Last updated by the study team

2026-02-05

Who can join

Age: 5 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A symptomatic or appropriate asymptomatic subject with a native or repaired right ventricular outflow tract requiring reconstruction with a valved conduit
• Age ≥5 years at the time of informed consent signature.
• Note: Additional Inclusion Criteria may apply

You may not qualify if…

• An artificial valve at another position or will need an artificial valve at another position (i.e. replacement at the time of index procedure or anticipated within 3 years).
• Subjects with previously implanted pacemaker (including defibrillators).
• Major or progressive non-cardiac disease (liver failure, renal failure, cancer) that has a life expectancy of less than one year.
• Note: Additional Exclusion Criteria may apply

Where it is running

• Lurie Children's Hospital — Chicago, Illinois, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.