NCT06088680

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

A Post Market Multicentre Retrospective Study of Glycar Bovine Pericardial Patch With AldeCaptm Technology (Aka SJM With EnCaptm Technology) in Cardiac and Vascular Repair or Reconstruction Surgery (CIP-003)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: GLYCAR SA (Pty) Ltd · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiac Defect
• Cardiac Anomaly
• Pericardial Defect

Interventions

Type	Name	Description
DEVICE	Glycar Pericardial Patch	Glycar Bovine pericardial patch with AldeCaptm Technology (aka SJM with EnCaptm technology)

Timeline

• Start date: 2023-09-26
• Primary completion: 2024-06-03
• Completion: 2024-06-03
• First posted: 2023-10-18
• Last updated: 2024-06-04

Locations

1 site across 1 country: South Africa