Cardiac Anomaly, Cardiac Defect, Pericardial Defect
Conditions
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.
Interventions
DEVICEGlycar Pericardial Patch
Glycar Bovine pericardial patch with AldeCaptm Technology (aka SJM with EnCaptm technology)
Sponsors
GLYCAR SA (Pty) Ltd
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reintervention | Within < 30 days post procedure | Incidence of patch related reintervention |
| Mortality | Within < 30 days post procedure | Incidence of patch related mortality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infection | Up to 2 years | Rate of occurrence of Patch infection (such as endocarditis) |
| Thrombus formation | Within < 30 days post procedure | Incidence of thrombus formation |
| Reintervention | Up to 2 years | Incidence of patch related reintervention |
| Unanticipated AEs | Up to 2 years | Incidence of patch Unanticipated Adverse Events |
| Unplanned reoperations | Up to 2 years | 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 |
| Mortality | Up to 2 years | Incidence of patch related mortality |
Countries
South Africa
Outcome results
None listed