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)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiac Defect
- Sponsor
- GLYCAR SA (Pty) Ltd
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Mortality
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
Mortality
Time Frame: Within < 30 days post procedure
Incidence of patch related mortality
Reintervention
Time Frame: Within < 30 days post procedure
Incidence of patch related reintervention
Secondary Outcomes
- Reintervention(Up to 2 years)
- Thrombus formation(Within < 30 days post procedure)
- Mortality(Up to 2 years)
- Unplanned reoperations(Up to 2 years)
- Infection(Up to 2 years)
- Unanticipated AEs(Up to 2 years)