NCT01808287

Safety and Performance Study of the Edwards SAPIEN 3 Transcatheter Heart Valve/ The SAPIEN 3 Study

Safety and Performance Study of the Edwards SAPIEN 3 Transcatheter Heart Valve

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Edwards Lifesciences · Industry
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this 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.

Detailed description

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.

Conditions

• Aortic Valve Disease

Interventions

Type	Name	Description
DEVICE	Edwards SAPIEN 3 Transcatheter Heart Valve	The Edwards SAPIEN 3 Transcatheter Heart Valve (THV) System is indicated for use in symptomatic patients (intermediate or higher operable risk) with severe aortic stenosis requiring aortic valve replacement (AVR).

Timeline

• Start date: 2013-01-01
• Primary completion: 2013-12-01
• Completion: 2019-12-17
• First posted: 2013-03-11
• Last updated: 2020-04-01

Locations

17 sites across 5 countries: Canada, France, Germany, Italy, United Kingdom