NCT03466918

China S3: Safety and Effectiveness of Edwards Lifesciences SAPIEN 3 THV in the Chinese Population

Safety and Effectiveness of Edwards Lifesciences SAPIEN 3 Transcatheter Heart Valve (THV) in the Chinese Population

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Edwards Lifesciences · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and effectiveness of the SAPIEN 3 (Edwards Lifesciences, Irvine, California) transcatheter heart valve implantation (TAVI) in Chinese patients with symptomatic severe calcific aortic stenosis who are considered at high risk for surgical valve replacement.

Detailed description

Edwards SAPIEN 3 Transcatheter Heart Valve and Commander delivery system will be used for this study. A maximum of 60 patients with symptomatic severe calcific aortic stenosis requiring transcatheter aortic valve implantation (TAVI), who are considered high risk for surgical valve replacement who received a SAPIEN 3 THV.

Conditions

• Aortic Stenosis
• Symptomatic Aortic Stenosis
• Aortic Regurgitation

Interventions

Type	Name	Description
DEVICE	SAPIEN 3 THV with the Commander delivery system	Edwards SAPIEN 3 Transcatheter Heart Valve is implanted using the Commander delivery system

Timeline

• Start date: 2018-05-23
• Primary completion: 2019-07-03
• Completion: 2024-06-19
• First posted: 2018-03-15
• Last updated: 2025-09-10
• Results posted: 2020-07-15

Locations

4 sites across 1 country: China

Regulatory

• FDA-regulated device study