China S3 PMS: SAPIEN 3 China Post Market Registry Study
NCT05168826 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 250
Last updated 2025-07-30
Summary
The objective of this study is to evaluate the long term safety and effectiveness of the SAPIEN 3 Transcatheter Heart Valve system in real world setting.
Conditions
- Aortic Stenosis, Severe
Interventions
- DEVICE
-
SAPIEN 3 Transcatheter Heart Valve
Implantation of the SAPIEN 3 valve
Sponsors & Collaborators
-
Edwards Lifesciences
lead INDUSTRY
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-01-24
- Primary Completion
- 2035-12-31
- Completion
- 2035-12-31
- FDA Device
- Yes
Countries
- China
Study Locations
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