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COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction

Pulmonary Valve Insufficiency Clinical Trial

Official title:
COngenital Multicenter Trial of Pulmonic vAlve Dysfunction Studying the SAPIEN 3 interventIONal THV

Clinical Trial Summary

This study will demonstrate the safety and effectiveness of the Edwards Lifesciences SAPIEN 3/SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) Systems in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02744677
Study type Interventional
Source Edwards Lifesciences
Contact Edwards THV Clinical Affairs
Phone (949) 250-2500
Email THV_CT.gov@Edwards.com
Status Recruiting
Phase N/A
Start date July 5, 2016
Completion date June 2031
View Details
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