Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-02-20 @ 5:56 PM
Study NCT ID:
NCT02755220
Status:
COMPLETED
Last Update Posted:
2022-04-28
First Post:
2016-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cingularbio® Heart Valve Clincial Study
Sponsor:
Shanghai Cingularbio Co. Ltd
Organization:
Study Overview
Official Title:
A Prospective, Mutli-center, Open Lable, Single Arm Study to Evaluate the Safety and Effectiveness of Cingularbio® Heart Valve in Aortic/Mitral Valve Replacement Patients
Status:
COMPLETED
Status Verified Date:
2020-04
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:
None
Brief Summary:
This study aimed to evaluate the safety and effectiveness of Cingularbio® heart valve in Aortic Valve Replacement and Mitral Valve Replacement in Chinese population
Detailed Description:
single arm, 12 month follow up, mutile center, to assess the safety and effectiveness of Cingularbio® heart valve in Aortic Valve Replacement and Mitral Valve Replacement patients
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: