Retrospective Clinical Data Collection on Carbomedics OptiForm Mitral Heart Valve

Recruiting

• Conditions: Mitral Valve Disease
• Interventions: Device: Mitral Valve Replacement

• Registration Number: NCT05898230
• Lead Sponsor: Corcym S.r.l

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

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 Timeline

• Study First Submitted: 2023-06-01
• Study First Submitted QC: 2023-06-01
• Study First Posted: 2023-06-12
• Study Start: 2023-11-23
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-06
• Last Update Posted: 2024-03-07
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects who have been implanted with the Carbomedics OptiForm Mitral Heart Valve	Mitral Valve Replacement	Mitral Valve Replacement with Carbomedics OptiForm Mitral Heart Valve

Primary Outcome Measures

Name	Time	Method
Valve-related bleeding	up to 7-8 year	The number and percentage of subjects with Valve-related bleeding
Mortality	up to 7-8 year	The number and percentage of subjects died
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
Prosthetic Valve Dysfunction	up to 7-8 year	The number and percentage of subjects with Prosthetic valve Dysfuntion
Valve thrombosis	up to 7-8 year	The number and percentage of subjects with Valve Thrombosis

Trial Locations

Locations (2)

The second Xiangya Hospital of Central South University; 🇨🇳 Changsha, China

West China hospital of Sichuan University; 🇨🇳 Chendu, China