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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Page 1 of 2 (6 locations)

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