Clinical trial NCT06088680: Post Market Observational Retrospective Study of Glycar Bovine Pericardial Patch (CIP-003)
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Defect
Cardiac Anomaly
Pericardial Defect
Lead sponsor: GLYCAR SA (Pty) Ltd
Sponsor class: INDUSTRY
First posted: 2023-10-18
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Reintervention
timeFrame: Within < 30 days post procedure
measure: Mortality
timeFrame: Within < 30 days post procedure
Secondary outcomes:
measure: Reintervention
timeFrame: Up to 2 years
measure: Mortality
timeFrame: Up to 2 years
measure: Infection
timeFrame: Up to 2 years
measure: Thrombus formation
timeFrame: Within < 30 days post procedure
measure: Unplanned reoperations
timeFrame: Up to 2 years
measure: Unanticipated AEs
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: Red Cross War Memorial Children's Hospital
state: Rondebosch
Study officials:
References: