Retrospective Clinical Data Collection on Carbomedics OptiForm Mitral Heart Valve
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Subjects who have been implanted with the Carbomedics OptiForm Mitral Heart Valve Mitral Valve Replacement with Carbomedics OptiForm Mitral Heart Valve |
Device: Mitral Valve Replacement
Mitral Valve Replacement with Carbomedics OptiForm Mitral Heart Valve
|
Outcome Measures
Primary Outcome Measures
- Prosthetic Valve Dysfunction [up to 7-8 year]
The number and percentage of subjects with Prosthetic valve Dysfuntion
- Mortality [up to 7-8 year]
The number and percentage of subjects died
- Valve-related bleeding [up to 7-8 year]
The number and percentage of subjects with Valve-related bleeding
- Valve thrombosis [up to 7-8 year]
The number and percentage of subjects with Valve Thrombosis
- Thromboembolism [up to 7-8 year]
The number and percentage of subjects with Thromboembolic events
- Endocarditis [up to 7-8 year]
The number and percentage of subjects with Endocarditis
- Valve-Related Reintervention [up to 7-8 year]
The number and percentage of subjects underwent Valve-related reintervention
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subject who has been treated with the Carbomedics OptiForm Mitral Heart Valve.
-
Subject (or representative or family member) who can understand the objective of the study and is willing to provide verbal informed consent and the available medical information.
Exclusion Criteria:
- Subject (or legal representative or family member) who do not provide their verbal consent to the data collection, or who are unable to provide follow-up information
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Corcym S.r.l
Investigators
- Study Director: Mara Chiaro, Corcym S.r.l
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CCH802