Trials / Not Yet Recruiting
Not Yet RecruitingNCT05977257
VitaFlow® Transcatheter Aortic Valve Replacement System Pre-market Trial Long Term Follow Up （VITAL）
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 89 (estimated)
- Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is an observational study to evaluate the long-term safety and effectiveness of the valve system.
Detailed description
This study is an observational study, for who have joined the VitaFlow® Catheter Aortic Valve System pre-market trial (Protocol No. valve -2014-04) in 4 designated research institutions, and follow-up from 6 to 10 years after the procedure, To evaluate the long-term safety and effectiveness of the valve system.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | VitaFlow® Transcatheter Aortic Valve Replacement System | This study is an observational study, for who have joined the VitaFlow® Catheter Aortic Valve System pre-market trial |
Timeline
- Start date
- 2023-07-30
- Primary completion
- 2025-10-30
- Completion
- 2028-10-30
- First posted
- 2023-08-04
- Last updated
- 2023-08-04
Locations
4 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05977257. Inclusion in this directory is not an endorsement.