Trials / Active Not Recruiting
Active Not RecruitingNCT05168826
China S3 PMS: SAPIEN 3 China Post Market Registry Study
SAPIEN 3 China Post Market Registry Study
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 250 (actual)
- Sponsor
- Edwards Lifesciences · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Detailed description
This is an observational, single-arm, multicentre, post-market study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SAPIEN 3 Transcatheter Heart Valve | Implantation of the SAPIEN 3 valve |
Timeline
- Start date
- 2022-01-24
- Primary completion
- 2035-12-01
- Completion
- 2035-12-01
- First posted
- 2021-12-23
- Last updated
- 2025-07-30
Locations
14 sites across 1 country: China
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05168826. Inclusion in this directory is not an endorsement.