Retrospective Clinical Data Collection on Carbomedics OptiForm Mitral Heart Valve

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-23

Study Completion Date

2024-12-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Mitral Valve Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Subjects who have been implanted with the Carbomedics OptiForm Mitral Heart Valve

Mitral Valve Replacement with Carbomedics OptiForm Mitral Heart Valve

Mitral Valve Replacement

Intervention Type DEVICE

Mitral Valve Replacement with Carbomedics OptiForm Mitral Heart Valve

Interventions

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Mitral Valve Replacement

Mitral Valve Replacement with Carbomedics OptiForm Mitral Heart Valve

Intervention Type DEVICE

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No