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)

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Anomaly; Cardiac Defect; Pericardial Defect
• Intervention / Treatment: Device: 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 Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Philisile Nxumalo; Phone Number: 27 12 667 1615; Email: philisile@glycar.co.za

Study Locations

• South Africa
  • Rondebosch
    • Cape Town, Rondebosch, South Africa, 7700
      • Recruiting
      • Red Cross War Memorial Children's Hospital
      • Contact: Thomas Aldersley, MD; Phone Number: 0216502419; Email: thomas.aldersley@uct.ac.za
      • Principal Investigator: Andre Brooks, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Open Label- Glycar Pericardial Patch; patients undergoing cardiovascular repair or reconstruction surgery under standard clinical care with the commercially available Glycar Pericardial Patch.	Device: Glycar Pericardial Patch; Glycar Bovine pericardial patch with AldeCaptm Technology (aka SJM with EnCaptm technology)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reintervention	Incidence of patch related reintervention	Within < 30 days post procedure
Mortality	Incidence of patch related mortality	Within < 30 days post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reintervention	Incidence of patch related reintervention	Up to 2 years
Mortality	Incidence of patch related mortality	Up to 2 years
Infection	Rate of occurrence of Patch infection (such as endocarditis)	Up to 2 years
Thrombus formation	Incidence of thrombus formation	Within < 30 days post procedure
Unplanned reoperations	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	Up to 2 years
Unanticipated AEs	Incidence of patch Unanticipated Adverse Events	Up to 2 years

Collaborators and Investigators

• Sponsor: GLYCAR SA (Pty) Ltd

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2023
• Primary Completion (Estimated): July 30, 2024
• Study Completion (Estimated): July 30, 2024

Study Registration Dates

• First Submitted: October 2, 2023
• First Submitted That Met QC Criteria: October 11, 2023
• First Posted (Actual): October 18, 2023

Study Record Updates

• Last Update Posted (Actual): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Defects, Congenital
• Other Study ID Numbers: CIP-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No