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COMPASSION - COngenital Multicenter Trial of Pulmonic VAlve Regurgitation Studying the SAPIEN InterventIONal THV

Pulmonary Regurgitation Clinical Trial

Official title:
Implantation of the SAPIEN Transcatheter Heart Valve (THV) in the Pulmonic Position

Clinical Trial Summary

To assess the safety and effectiveness of pulmonic THV implantation in subjects with dysfunctional RVOT conduit requiring treatment for moderate or severe pulmonary regurgitation (≥3+ pulmonary regurgitation) and/or RVOT conduit obstruction (mean gradient of >=35mmHg) by TTE.

Clinical Trial Description

The study design is a multi-center, prospective, non-randomized study of up to 70 implanted subjects (US) with no site representing more than 30% of the implanted subjects. The subjects will include those subjects who have previously undergone placement of a conduit between the right ventricle and pulmonary artery and now present with a dysfunctional RVOT conduit requiring treatment for moderate or severe pulmonary regurgitation and/or RVOT conduit obstruction. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00676689
Study type Interventional
Source Edwards Lifesciences
Contact
Status Completed
Phase N/A
Start date April 8, 2008
Completion date December 31, 2019
View Details
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