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NCT05898230 Clinical Trial

Retrospective Clinical Data Collection on Carbomedics OptiForm Mitral Heart Valve

Mitral Valve Disease Clinical Trial

Official title:
Retrospective Clinical Data Collection on Carbomedics OptiForm Mitral Heart Valve

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05898230
Other study ID # CCH802
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 23, 2023
Est. completion date December 2024

Study information
Verified date March 2024
Source Corcym S.r.l
Contact Steven Zhang
Phone +86 138 1023 2090
Email steven.zhang@corcym.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 400
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Mitral Valve Replacement
Mitral Valve Replacement with Carbomedics OptiForm Mitral Heart Valve

Locations
Country Name City State
China The second Xiangya Hospital of Central South University Changsha
China West China hospital of Sichuan University Chendu

Sponsors (1)
Lead Sponsor Collaborator
Corcym S.r.l

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Prosthetic Valve Dysfunction The number and percentage of subjects with Prosthetic valve Dysfuntion up to 7-8 year
Primary Mortality The number and percentage of subjects died up to 7-8 year
Primary Valve-related bleeding The number and percentage of subjects with Valve-related bleeding up to 7-8 year
Primary Valve thrombosis The number and percentage of subjects with Valve Thrombosis up to 7-8 year
Primary Thromboembolism The number and percentage of subjects with Thromboembolic events up to 7-8 year
Primary Endocarditis The number and percentage of subjects with Endocarditis up to 7-8 year
Primary Valve-Related Reintervention The number and percentage of subjects underwent Valve-related reintervention up to 7-8 year
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