Retrospective Clinical Data Collection on Carbomedics OptiForm Mitral Heart Valve

Corcym

Status

Enrolling

Conditions

Mitral Valve Disease

Treatments

Device: Mitral Valve Replacement

Study type

Observational

Funder types

Industry

Identifiers

NCT05898230

CCH802

Details and patient eligibility

About

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

Full 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.

Enrollment

400 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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