Active — Not RecruitingNot Applicable

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

United States15 participantsStarted 2018-06-07

Plain-language summary

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).

Who can participate

Age range5 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Valve-related mortality and device-related re-intervention

Timeframe: 6 months

Trial details

NCT IDNCT03441971

SponsorW.L.Gore & Associates

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-04-13

View on ClinicalTrials.gov More Heart Defects, Congenital trials