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

Last updated: June 3, 2024
Sponsor: GLYCAR SA (Pty) Ltd
Overall Status: Completed

Phase

N/A

Condition

Heart Defect

Treatment

Glycar Pericardial Patch

Clinical Study ID

NCT06088680
CIP-003
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • If no waiver has been granted by the Ethics committee: Participants (all age) orlegal guardian has signed the informed consent

  • Participant has undergone a cardiac or vascular procedure which falls within theindications for use and required the use of Glycar Pericardial Patch

Exclusion

Exclusion Criteria:

  • There are no study specific exclusion criteria. Participants have already beentreated per standard clinical practice.

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Glycar Pericardial Patch
Phase:
Study Start date:
September 26, 2023
Estimated Completion Date:
June 03, 2024

Study 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.

Connect with a study center

  • Red Cross War Memorial Children's Hospital

    Cape Town, Rondebosch 7700
    South Africa

    Site Not Available

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