Ignite Creation Date:
2024-05-06 @ 7:20 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05977257
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-08-04
First Post:
2023-07-10
Brief Title:
VitaFlow Transcatheter Aortic Valve Replacement System Pre-market Trial Long Term Follow Up VITAL
Sponsor:
Shanghai MicroPort CardioFlow Medtech Co Ltd
Organization:
Shanghai MicroPort CardioFlow Medtech Co Ltd
Study Overview
Official Title:
VitaFlow Transcatheter Aortic Valve Replacement System Pre-market Trial Long Term Follow Up VITAL
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
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:
VITAL
Brief 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
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