What is the Purpose of this Study?
The SAPIEN 3 THV System was recently approved for use in patients with a dysfunctional RVOT conduit or previously implanted surgical valve in the pulmonic position with a clinical indication for intervention. The objective of this study is to monitor device performance and outcomes in the post-approval setting.
Eligibility
- Dysfunctional RVOT conduit or previously implanted surgical valve
- RVOT/PV with ≥ moderate regurgitation and/or a mean RVOT/PV gradient of ≥ 35 mmHg
Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
COngenital Multicenter trial of Pulmonic vAlve dysfunction Studying the SAPIEN 3? InterventIONal THV Post-Approval Study