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Pulmonic Valve REplacement Multi-discIpline EMEA Registry

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Contents

clinicaltrials.gov/study/NCT01356108
Is a
‌
Clinical study
0

Clinical Study attributes

NCT Number
NCT013561080
Health Conditions in Trial
Pulmonary insufficiency
Pulmonary insufficiency
0
Trial Recruitment Size
1270
Trial Sponsor
Edwards Lifesciences
Edwards Lifesciences
0
Clinical Trial Start Date
2011
0
Primary Completion Date
2013
0
Study Completion Date
December 19, 2017
0
Clinical Trial Study Type
Observational0
Observational Clinical Trial Type
Cohort0
Observational Study Perspective
Prospective0
Participating Facility
Mater Misericordiae University Hospital
Mater Misericordiae University Hospital
0
‌
Universitätsklinikum Münster
0
Manchester Royal Infirmary
Manchester Royal Infirmary
0
Royal Brompton Hospital
Royal Brompton Hospital
0
Official Name
Implantation of the SAPIEN™ Transcatheter Heart Valve (THV) in the Pulmonic Position0
Last Updated
November 20, 2018
0
Study summary

The purpose of this registry is to retrospectively and prospectively obtain clinical data in consecutively treated patients, in order to demonstrate that the commercially available Edwards SAPIEN Valve with the RF3 delivery system is a safe and effective treatment for patients with pulmonary regurgitation or stenosis.

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