Evaluating the safety of Carbomedics OptiForm Mitral Heart Valve
Retrospective Clinical Data Collection on Carbomedics OptiForm Mitral Heart Valve
This study is testing the long-term safety of the Carbomedics OptiForm Mitral Heart Valve in patients with mitral valve disease in China to see if it causes any serious problems after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Sex | All |
| Sponsor | Corcym S.r.l Industry-sponsored |
| Locations | 2 sites (Changsha and 1 other locations) |
| Trial ID | NCT05898230 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the medium- to long-term safety of the Carbomedics OptiForm Mitral Heart Valve in patients with mitral valve disease in China. It involves retrospective data collection from approximately 400 subjects who have undergone mitral valve replacement with this specific valve. The study will analyze valve-related serious adverse events, including dysfunction, bleeding, thrombosis, and endocarditis, to establish a comprehensive safety profile for regulatory purposes. The data will be collected from two clinical sites in China.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals who have been treated with the Carbomedics OptiForm Mitral Heart Valve.
Not a fit: Patients who have not received the Carbomedics OptiForm Mitral Heart Valve or those unable to provide consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety of the Carbomedics OptiForm Mitral Heart Valve, potentially improving patient outcomes and informing future clinical practices.
How similar studies have performed: Other studies evaluating the safety of heart valves have shown success, indicating that this approach is supported by prior research.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Changsha and 1 other locations
- The second Xiangya Hospital of Central South University — Changsha, China (Recruiting)
- West China hospital of Sichuan University — Chendu, China (Recruiting)
Study contacts
- Study coordinator: Steven Zhang
- Email: steven.zhang@corcym.com
- Phone: +86 138 1023 2090
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.