Trials / Unknown
UnknownNCT04655742
VitaFlow™ Transcatheter Aortic Valve System Pre-market Trial
A Prospective, Multi-center, Single-arm Clinical Investigation for Evaluation of the Safety and Effectiveness of the MicroPort™ CardioFlow VitaFlow™ Transcatheter Aortic Valve System in the Treatment of Severe Aortic Stenosis
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 120 (actual)
- Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd. · Industry
- Sex
- All
- Age
- 70 Years
- Healthy volunteers
- Not accepted
Summary
This is a pre-market clinical investigation aiming to evaluate the safety and effectiveness of MicroPort™ CardioFlow VitaFlow™ Transcatheter Aortic Valve System for the treatment of severe aortic stenosis.
Detailed description
This is a prospective, multi-center, single-arm clinical investigation for evaluation of the safety and effectiveness of the MicroPort™ CardioFlow VitaFlow™ Transcatheter Aortic Valve System in the Treatment of Severe Aortic Stenosis. The investigation has two phases. Phase I（FIM）：The FIM stage is a prospective, multicenter, single-arm observational clinical investigation, aiming to evaluate the feasibility and safety of the MicroPort™ CardioFlow VitaFlow™ Transcatheter Aortic Valve System. A total of 10 patients will be enrolled and 30-day clinical outcomes will be collected. Phase II (Pivotal)：The pivotal stage is a prospective, multi-center, single-arm clinical investigation with the performance goal, aiming to evaluate the safety and effectiveness of MicroPort™ CardioFlow VitaFlow™ Transcatheter Aortic Valve System for the treatment of severe aortic stenosis. A total of 110 patients will be enrolled in 11 clinical centers across China. Clinical or telephone follow-up is scheduled at 30 days, 6 months, 12 months, and 2 to 5 years annually post-procedure.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | VitaFlow™ Transcatheter Aortic Valve System | VitaFlow™ Transcatheter Aortic Valve System contains a valve stent-VitaFlow™ Aortic Valve, a delivery system-VitaFlow™ Delivery System,loading tools, a balloon dilatation catheter, and an introducer set |
Timeline
- Start date
- 2014-06-27
- Primary completion
- 2017-09-06
- Completion
- 2021-12-31
- First posted
- 2020-12-07
- Last updated
- 2020-12-07
Locations
4 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04655742. Inclusion in this directory is not an endorsement.