Retrospective Clinical Data Collection on Carbomedics OptiForm Mitral Heart Valve

March 6, 2024 updated by: Corcym S.r.l

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Changsha, China
        • Recruiting
        • The second Xiangya hospital of central south university
        • Contact:
      • Chendu, China
        • Recruiting
        • West China Hospital of Sichuan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Subjects who have been implanted with the Carbomedics OptiForm Mitral Heart Valve
Mitral Valve Replacement with Carbomedics OptiForm Mitral Heart Valve
Device: Mitral Valve Replacement
Mitral Valve Replacement with Carbomedics OptiForm Mitral Heart Valve

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prosthetic Valve Dysfunction
Time Frame: up to 7-8 year
The number and percentage of subjects with Prosthetic valve Dysfuntion
up to 7-8 year
Mortality
Time Frame: up to 7-8 year
The number and percentage of subjects died
up to 7-8 year
Valve-related bleeding
Time Frame: up to 7-8 year
The number and percentage of subjects with Valve-related bleeding
up to 7-8 year
Valve thrombosis
Time Frame: up to 7-8 year
The number and percentage of subjects with Valve Thrombosis
up to 7-8 year
Thromboembolism
Time Frame: up to 7-8 year
The number and percentage of subjects with Thromboembolic events
up to 7-8 year
Endocarditis
Time Frame: up to 7-8 year
The number and percentage of subjects with Endocarditis
up to 7-8 year
Valve-Related Reintervention
Time Frame: up to 7-8 year
The number and percentage of subjects underwent Valve-related reintervention
up to 7-8 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corcym S.r.l

Investigators

  • Study Director: Sara Gaggianesi, Corcym S.r.l

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 23, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

June 1, 2023

First Submitted That Met QC Criteria

June 1, 2023

First Posted (Actual)

June 12, 2023

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • CCH802

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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