Trials / Completed
CompletedNCT03314857
China XT: Safety and Effectiveness of Edwards Lifesciences SAPIEN XT THV in the Chinese Population
Safety and Effectiveness of Edwards Lifesciences SAPIEN XT Transcatheter Heart Valve in the Chinese Population
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 67 (actual)
- Sponsor
- Edwards Lifesciences · Industry
- Sex
- All
- Age
- 60 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the safety and effectiveness of the SAPIEN XT (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 XT™ Transcatheter Heart Valve and NovaFlex+ delivery system will be used for this study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SAPIEN XT THV with the NovaFlex+ delivery system | Edwards SAPIEN XT™ Transcatheter Heart Valve along with NovaFlex+ delivery system |
Timeline
- Start date
- 2017-09-18
- Primary completion
- 2018-07-06
- Completion
- 2023-06-15
- First posted
- 2017-10-19
- Last updated
- 2023-09-05
- Results posted
- 2020-07-15
Locations
3 sites across 1 country: China
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03314857. Inclusion in this directory is not an endorsement.