Post Market Observational Retrospective Study of Glycar Bovine Pericardial Patch (CIP-003)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | 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)
|
Outcome Measures
Primary Outcome Measures
- Reintervention [Within < 30 days post procedure]
Incidence of patch related reintervention
- Mortality [Within < 30 days post procedure]
Incidence of patch related mortality
Secondary Outcome Measures
- Reintervention [Up to 2 years]
Incidence of patch related reintervention
- Mortality [Up to 2 years]
Incidence of patch related mortality
- 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
- 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
- Unanticipated AEs [Up to 2 years]
Incidence of patch Unanticipated Adverse Events
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Red Cross War Memorial Children's Hospital | Cape Town | Rondebosch | South Africa | 7700 |
Sponsors and Collaborators
- GLYCAR SA (Pty) Ltd
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CIP-003