The purpose of the SAPIEN 3 study is to assess the safety and device success of the Edwards SAPIEN 3 Transcatheter Heart Valve (S3 THV) and the Edwards Commander and Certitude Delivery Systems in patients with symptomatic, severe aortic stenosis who are indicated for aortic valve replacement.
This is a non-randomized, prospective, multicenter safety and device success study. Two hundred fifty (250) patients are planned to be enrolled at up to 20 participating investigational centers in Europe and Canada. Patient participation will last for a minimum of 5 years. Patients will be assessed at the following intervals: baseline, hospital discharge, 30 days, 1 year and annually thereafter for a minimum of 5 years.
ClinicalTrials.gov ID NCT01808287
Sponsor
Primary endpoints
All-cause mortality at 30 days post-index procedure
CERC Services
- Clinical Events Committee (CEC) activities
Countries
France, Germany, Ireland, Italy, United Kingdom
Number of investigational sites
17
Number of patients
250
