Status:
ACTIVE_NOT_RECRUITING
Evaluation of the GORE PV1 Device in Patients With Pulmonary Valve Dysfunction
Lead Sponsor:
W.L.Gore & Associates
Conditions:
Heart Defects, Congenital
Tetralogy of Fallot
Eligibility:
All Genders
5+ years
Phase:
NA
Brief 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).
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2030
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03441971
Start Date
June 7 2018
End Date
March 1 2030
Last Update
January 27 2025
Active Locations (3)
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1
Lurie Children's Hospital
Chicago, Illinois, United States, 60611
2
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
3
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205