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

Completed

• Conditions: Cardiac Defect; Cardiac Anomaly; Pericardial Defect
• Interventions: Device: Glycar Pericardial Patch

• Registration Number: NCT06088680
• Lead Sponsor: GLYCAR SA (Pty) Ltd

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

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 available Glycar Pericardial Patch in patients undergoing cardiovascular repair or reconstruction surgery.

This real-world evidence retrospective data collection single-arm multicentre, observational, non-interventional study will enrol up to a minimum of 50 consecutive participants who meet inclusion criteria, in 2-3 centres. The study is aimed at providing real-world evidence of the Glycar Pericardial patch.

Retrospective data analysis will include collected clinical data from consecutive participants with a minimum of 2 years follow up, meaning from 30 June 2020 and going back in time. The quality of medical history being recorded is believed to be more reliable and complete in the most recent years. Therefore, it was decided to start enrolling consecutive participants in a reverse chronological order.

Study Timeline

• Study Start: 2023-09-26
• Study First Submitted: 2023-10-02
• Study First Submitted QC: 2023-10-11
• Study First Posted: 2023-10-18
• Status Verified: 2024-06
• Primary Completion: 2024-06-03
• Study Completion: 2024-06-03
• Last Update Submitted: 2024-06-03
• Last Update Posted: 2024-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Open Label- Glycar Pericardial Patch	Glycar Pericardial Patch	patients undergoing cardiovascular repair or reconstruction surgery under standard clinical care with the commercially available Glycar Pericardial Patch.

Primary Outcome Measures

Name	Time	Method
Mortality	Within < 30 days post procedure	Incidence of patch related mortality
Reintervention	Within < 30 days post procedure	Incidence of patch related reintervention

Secondary Outcome Measures

Name	Time	Method
Reintervention	Up to 2 years	Incidence of patch related reintervention
Thrombus formation	Within < 30 days post procedure	Incidence of thrombus formation
Mortality	Up to 2 years	Incidence of patch related mortality
Unplanned reoperations	Up to 2 years	The total number of unplanned reoperations required in patients over the FU period which include the repair or alteration of the surgical area around the patch. Patients with planned reoperations at the time of the primary index procedure will not be considered
Infection	Up to 2 years	Rate of occurrence of Patch infection (such as endocarditis)
Unanticipated AEs	Up to 2 years	Incidence of patch Unanticipated Adverse Events

Trial Locations

Locations (1)

Red Cross War Memorial Children's Hospital; 🇿🇦 Cape Town, Rondebosch, South Africa