CompletedNot Applicable

Post Market Observational Retrospective Study of Glycar Bovine Pericardial Patch (CIP-003)

South Africa50 participantsStarted 2023-09-26

Plain-language 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 patients undergoing cardiovascular repair or reconstruction surgery under standard clinical care with the commercially available Glycar Pericardial Patch.

Who can participate

SexALL

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Inclusion Criteria: * 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 Criteria: \- There are no study specific exclusion criteria. Participants have already been treated per standard clinical practice.

What they're measuring

Reintervention

Timeframe: Within < 30 days post procedure

Mortality

Timeframe: Within < 30 days post procedure

Trial details

NCT IDNCT06088680

SponsorGLYCAR SA (Pty) Ltd

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-06-03

View on ClinicalTrials.gov More Cardiac Defect trials