Trials / Not Yet Recruiting
Not Yet RecruitingNCT07450196
A Prospective, Multicenter, Observational Study Evaluating Safety and Effectiveness of SAPIEN 3 Transcatheter Aortic Valve Replacement for Type-0 Bicuspid Aortic Valve Stenosis Patients in China
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 170 (estimated)
- Sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital · Academic / Other
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
In China, bicuspid aortic valve (BAV) represents a significantly high proportion of the transcatheter aortic valve replacement (TAVR) population. The application of TAVR in patients with BAV is challenging due to complex anatomy. To date, no prospective study has evaluated the Sapien 3 TAVR in patients with Type-0 BAV.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Transcatheter Aortic Valve Replacement | Transcatheter Aortic Valve Replacement for patients with Type-0 bicuspid aortic stenosis. |
Timeline
- Start date
- 2026-04-15
- Primary completion
- 2028-08-31
- Completion
- 2029-08-31
- First posted
- 2026-03-04
- Last updated
- 2026-04-15
Locations
1 site across 1 country: China
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07450196. Inclusion in this directory is not an endorsement.