Mitral Valve DiseaseNCT05898230
Retrospective Clinical Data Collection on Carbomedics OptiForm Mitral Heart Valve
An observational study of Mitral Valve Disease, run by Corcym S.r.l at 2 sites in China.
Trial 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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mitral Valve Disease
- What is being tested?
- Mitral Valve Replacement
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- 2 sitesChina
- Study dates
- 23 Nov 2023to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects who have been implanted with the Carbomedics OptiForm Mitral Heart Valve
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
The second Xiangya Hospital of Central South University
Changsha
Liming Liu, liulimingjia@aliyun.com
- Recruiting
West China hospital of Sichuan University
Chendu
Zhong Wu, wuzhong71@163.com
About this study
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
Read the 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.
- Conditions
- Mitral Valve Disease
- Being tested
- Mitral Valve Replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitral Valve ReplacementDevice
Mitral Valve Replacement with Carbomedics OptiForm Mitral Heart Valve
| Study group | Role | What they receive |
|---|---|---|
| Subjects who have been implanted with the Carbomedics OptiForm Mitral Heart Valve | Mitral Valve Replacement with Carbomedics OptiForm Mitral Heart Valve Receives: Device: Mitral Valve Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prosthetic Valve Dysfunction
The number and percentage of subjects with Prosthetic valve Dysfuntion
Measured: up to 7-8 year
Mortality
The number and percentage of subjects died
Measured: up to 7-8 year
Valve-related bleeding
The number and percentage of subjects with Valve-related bleeding
Measured: up to 7-8 year
Valve thrombosis
The number and percentage of subjects with Valve Thrombosis
Measured: up to 7-8 year
Thromboembolism
The number and percentage of subjects with Thromboembolic events
Measured: up to 7-8 year
Endocarditis
The number and percentage of subjects with Endocarditis
Measured: up to 7-8 year
Valve-Related Reintervention
The number and percentage of subjects underwent Valve-related reintervention
Measured: up to 7-8 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start23 Nov 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corcym S.r.l
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sara Gaggianesi, Study director, Corcym S.r.l
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05898230
- Sponsor's protocol ID
- CCH802
- Status last verified
- Mar 2024
- First submitted
- 1 Jun 2023
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Clinical Data Collection on Carbomedics OptiForm Mitral Heart Valve
- ClinicalTrials.gov ID
- NCT05898230
- Acronym / sponsor ID
- CCH802
- Conditions
- Mitral Valve Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Corcym S.r.lIndustry (pharma, biotech, devices)
- Study start
- 23 Nov 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 12 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects who have been implanted with the Carbomedics OptiForm Mitral Heart Valve | – | Device: Mitral Valve ReplacementMitral Valve Replacement with Carbomedics OptiForm Mitral Heart Valve |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects who have been implanted with the Carbomedics OptiForm Mitral Heart Valve
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mitral Valve ReplacementMitral Valve Replacement with Carbomedics OptiForm Mitral Heart Valve | Device | Subjects who have been implanted with the Carbomedics OptiForm Mitral Heart Valve |
Primary outcome
Prosthetic Valve Dysfunction
Time frame: up to 7-8 year
The number and percentage of subjects with Prosthetic valve Dysfuntion
Mortality
Time frame: up to 7-8 year
The number and percentage of subjects died
Valve-related bleeding
Time frame: up to 7-8 year
The number and percentage of subjects with Valve-related bleeding
Valve thrombosis
Time frame: up to 7-8 year
The number and percentage of subjects with Valve Thrombosis
Thromboembolism
Time frame: up to 7-8 year
The number and percentage of subjects with Thromboembolic events
Endocarditis
Time frame: up to 7-8 year
The number and percentage of subjects with Endocarditis
Valve-Related Reintervention
Time frame: up to 7-8 year
The number and percentage of subjects underwent Valve-related reintervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Gaggianesi study director
Corcym S.r.l
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Valve Disease, run by Corcym S.r.l at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Steven Zhang (+86 138 1023 2090, steven.zhang@corcym.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prosthetic Valve Dysfunction (time frame: up to 7-8 year). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2024.