Retrospective Clinical Data Collection on Carbomedics OptiForm Mitral Heart Valve
1 other identifier
observational
400
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2023
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2023
CompletedFirst Posted
Study publicly available on registry
June 12, 2023
CompletedStudy Start
First participant enrolled
November 23, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedMarch 7, 2024
March 1, 2024
1 year
June 1, 2023
March 6, 2024
Conditions
Outcome Measures
Primary Outcomes (7)
Prosthetic Valve Dysfunction
The number and percentage of subjects with Prosthetic valve Dysfuntion
up to 7-8 year
Mortality
The number and percentage of subjects died
up to 7-8 year
Valve-related bleeding
The number and percentage of subjects with Valve-related bleeding
up to 7-8 year
Valve thrombosis
The number and percentage of subjects with Valve Thrombosis
up to 7-8 year
Thromboembolism
The number and percentage of subjects with Thromboembolic events
up to 7-8 year
Endocarditis
The number and percentage of subjects with Endocarditis
up to 7-8 year
Valve-Related Reintervention
The number and percentage of subjects underwent Valve-related reintervention
up to 7-8 year
Study Arms (1)
Subjects who have been implanted with the Carbomedics OptiForm Mitral Heart Valve
Mitral Valve Replacement with Carbomedics OptiForm Mitral Heart Valve
Interventions
Mitral Valve Replacement with Carbomedics OptiForm Mitral Heart Valve
Eligibility Criteria
Subjects who have been implanted with the Carbomedics OptiForm Mitral Heart Valve
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Corcym S.r.llead
Study Sites (2)
The second Xiangya Hospital of Central South University
Changsha, China
West China hospital of Sichuan University
Chendu, China
Study Officials
- STUDY DIRECTOR
Sara Gaggianesi
Corcym S.r.l
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2023
First Posted
June 12, 2023
Study Start
November 23, 2023
Primary Completion
December 1, 2024
Study Completion
December 1, 2024
Last Updated
March 7, 2024
Record last verified: 2024-03