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Clinical Trial Summary

Prospective, longitudinal, open-label, multicentre, observational, non-comparative national study using an exhaustive registry of implantations over a given period.

This study is requested by French Health Authorities for reimbursement renewal, to maintain reimbursement for pulmonary valvular replacement by bioprothesis in approved indication in France.


Clinical Trial Description

This is a prospective, longitudinal, open-label, multicentre, observational, non-comparative national study using an exhaustive registry of implantations over a given period in France. The study is requested by French Health Authorities in 2010 for reimbursement renewal, to maintain reimbursement for pulmonary valvular replacement by bioprothesis in approved indication in France. The study was closed in 2013. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02023775
Study type Observational [Patient Registry]
Source Medtronic Bakken Research Center
Contact
Status Completed
Phase
Start date January 31, 2010
Completion date October 20, 2013