Status:
COMPLETED
Post Market Observational Retrospective Study of Glycar Bovine Pericardial Patch (CIP-003)
Lead Sponsor:
GLYCAR SA (Pty) Ltd
Conditions:
Cardiac Defect
Cardiac Anomaly
Eligibility:
All Genders
Brief Summary
The overall purpose of this observational Post Market Clinical Follow Up (PMCF) study is to ensure continued acceptability of the benefit risk ratio by assessment of safety and performance, in patient...
Detailed Description
To comply with Medical Device Regulation (MDR) Post Market Clinical Follow Up (PMCF) requirements through proactive ongoing assessment of the safety, efficacy, and performance of the commercially avai...
Eligibility Criteria
Inclusion
- If no waiver has been granted by the Ethics committee: Participants (all age) or legal guardian has signed the informed consent
- Participant has undergone a cardiac or vascular procedure which falls within the indications for use and required the use of Glycar Pericardial Patch
Exclusion
- \- There are no study specific exclusion criteria. Participants have already been treated per standard clinical practice.
Key Trial Info
Start Date :
September 26 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 3 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06088680
Start Date
September 26 2023
End Date
June 3 2024
Last Update
June 4 2024
Active Locations (1)
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1
Red Cross War Memorial Children's Hospital
Cape Town, Rondebosch, South Africa, 7700