Ignite Creation Date:
2024-05-06 @ 3:30 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04655742
Status:
UNKNOWN
Last Update Posted:
2020-12-07
First Post:
2020-11-30
Brief Title:
VitaFlow Transcatheter Aortic Valve System Pre-market Trial
Sponsor:
Shanghai MicroPort CardioFlow Medtech Co Ltd
Organization:
Shanghai MicroPort CardioFlow Medtech Co Ltd
Study Overview
Official Title:
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
Status Verified Date:
2020-11
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 IFIMThe 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 PivotalThe 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
Phase IFIMThe 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 PivotalThe 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None