Status:
UNKNOWN
Transcatheter Pulmonary Valve Implantation With SAPIEN 3 Valve
Lead Sponsor:
Centre Chirurgical Marie Lannelongue
Collaborating Sponsors:
Institut für Pharmakologie und Präventive Medizin
Conditions:
Pulmonary Valve; Failure
Percutaneous Pulmonary Valve Implantation
Eligibility:
All Genders
5-110 years
Brief Summary
Background Transcatheter pulmonary valve implantation (TPVI) is indicated to treat right ventricular outflow tract dysfunction in patients with congenital heart diseases. Long-term outcomes following ...
Detailed Description
1. INTRODUCTION Percutaneous pulmonary valve implantation (PPVI) is effective to treat right ventricle outflow (RVOT) dysfunction. First reported by Bonhoeffer et al. in 2000, PPVI extends the lifespa...
Eligibility Criteria
Inclusion
- Patient with congenital heart disease, dysfunctional right ventricle outflow tract and indications for percutaneous pulmonary valve replacement as indicated by international guidelines-
- Patient having a valve replacement using a SAPIEN 3 valve
Exclusion
- Patient having a valve replacement using a SAPIEN XT valve
- Patient having a valve replacement using a Melody valve
- Patient having a valve replacement using a Harmony valve
- Patient having a valve replacement using a Venus-P valve
- Patient refusing participation to the study
Key Trial Info
Start Date :
September 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2022
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT05264181
Start Date
September 1 2021
End Date
August 1 2022
Last Update
March 3 2022
Active Locations (1)
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1
Hopital Marie Lannelongue
Le Plessis-Robinson, France, 92350