Ignite Creation Date:
2024-05-06 @ 7:05 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05898230
Status:
RECRUITING
Last Update Posted:
2024-03-07
First Post:
2023-06-01
Brief Title:
Retrospective Clinical Data Collection on Carbomedics OptiForm Mitral Heart Valve
Sponsor:
Corcym Srl
Organization:
Corcym Srl
Study Overview
Official Title:
Retrospective Clinical Data Collection on Carbomedics OptiForm Mitral Heart Valve
Status:
RECRUITING
Status Verified Date:
2024-03
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:
The objective of this study is to evaluate the medium- to long-term safety of the Carbomedics OptiForm Mitral Heart Valve after the implantation for mitral valve disease in the Chinese population
The study is designed as a post-market retrospective single arm and multicentric data collection
The study is designed as a post-market retrospective single arm and multicentric data collection
Detailed Description:
This study is conducted to evaluate the medium and long-term safety of the Carbomedics OptiForm Mitral Heart Valve after the implantation for mitral valve disease The data will be used for regulatory purposes to support the re-certification of the valve in the Chinese market
Valve-related SAEs such as prosthetic valve dysfunction death valve-related bleeding events valve thrombosis and thromboembolic events endocarditis and reintervention will be studied to describe the safety profile of the valve Data of approximately 400 subjects will be collected in two clinical sites in China
Valve-related SAEs such as prosthetic valve dysfunction death valve-related bleeding events valve thrombosis and thromboembolic events endocarditis and reintervention will be studied to describe the safety profile of the valve Data of approximately 400 subjects will be collected in two clinical sites in China
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None