Status:
COMPLETED
Pulmonic SAPIEN XT THV
Lead Sponsor:
Institut für Pharmakologie und Präventive Medizin
Collaborating Sponsors:
Estimate, GmbH
Conditions:
Pulmonary Valve Malfunction
Eligibility:
All Genders
18+ years
Brief Summary
Multi-center, Observational Registry with Retrospective Enrollment and Prospective Follow-up. The aim of the registry is to document the feasibility and safety of implanting an Edwards SAPIEN XT tran...
Detailed Description
A malfunction or dysplasia of the pulmonary valve or the right ventricular outflow tract (RVOT) is one of the major components of the cardiac physiology in many congenital heart defects. Surgical corr...
Eligibility Criteria
Inclusion
- Clinical indication and decision for the implantation of an Edwards SAPIEN XT THV made
- Data release form
Exclusion
- none
Key Trial Info
Start Date :
November 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2017
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT02302131
Start Date
November 1 2014
End Date
April 1 2017
Last Update
April 5 2017
Active Locations (6)
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1
Gent University Hospital
Ghent, Belgium
2
UZ Leuven
Leuven, Belgium
3
St Pauls Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
4
Toronto General
Toronto, Ontario, Canada, M5G 2C4