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

Cardiac Anomaly Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06088680
• Other study ID #: CIP-003
• Status: Recruiting
• Start date: September 26, 2023
• Est. completion date: July 30, 2024

Study information

• Verified date: February 2024
• Source: GLYCAR SA (Pty) Ltd
• Contact: Philisile Nxumalo
• Phone: 27 12 667 1615
• Email: philisile[@]glycar.co.za
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 30, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Anomaly
• Cardiac Defect
• Heart Defects, Congenital

Intervention

Device:
• Glycar Pericardial Patch
Glycar Bovine pericardial patch with AldeCaptm Technology (aka SJM with EnCaptm technology)

Locations

Country	Name	City	State
South Africa	Red Cross War Memorial Children's Hospital	Cape Town	Rondebosch

Sponsors (1)

Lead Sponsor	Collaborator
GLYCAR SA (Pty) Ltd

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reintervention	Incidence of patch related reintervention	Within < 30 days post procedure
Primary	Mortality	Incidence of patch related mortality	Within < 30 days post procedure
Secondary	Reintervention	Incidence of patch related reintervention	Up to 2 years
Secondary	Mortality	Incidence of patch related mortality	Up to 2 years
Secondary	Infection	Rate of occurrence of Patch infection (such as endocarditis)	Up to 2 years
Secondary	Thrombus formation	Incidence of thrombus formation	Within < 30 days post procedure
Secondary	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
Secondary	Unanticipated AEs	Incidence of patch Unanticipated Adverse Events	Up to 2 years