Safety and Effectiveness of Edwards Lifesciences SAPIEN 3 Transcatheter Heart Valve (THV) in the Chinese Population
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 60
Summary
- Conditions
- Aortic Regurgitation
- Aortic Stenosis
- Symptomatic Aortic Stenosis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 19 years and 125 years
- Gender
- Both males and females
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 re...
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.
Tracking Information
- NCT #
- NCT03466918
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Prof Junbo GE Zhongshan Hospital and Fudan University
Get Well Soon