GLYCAR Post Market Multicenter Study

Study Overview
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Brief Summary
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Prospective, non-interventional, observational, multi-center, single arm, post market clinical follow-up study

Detailed Description
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This real-world, single-arm, multi-center, observational, non-interventional prospective registry will enroll up to 100 consecutive subjects undergoing cardiac and/or vascular repair or reconstruction surgery in 10-12 investigative sites in the European Union (EU), South Africa and USA. The study is aimed at providing real-world evidence of the Glycar Pericardial patch device performance and incidence of clinical outcomes in patients undergoing cardiac and/or vascular repair or reconstruction surgery related to Glycar Pericardial patch.

Official Title
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A Post Market Multicenter Clinical Investigation of GLYCAR Bovine Pericardial Patch With EnCap™ Technology in Cardiac and Vascular Repair or Reconstruction Surgery. GLYCAR Study

Conditions
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Congenital Premature Cardiac Closure, Cardiac and Great Vessel Reconstruction and Repair, Peripheral Vascular Reconstruction and Repair

Intervention / Treatment
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* Device: GLYCAR Pericardial Patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients (to be) treated with Glycar Pericardial patch as per IFU and standard clinical practice. The patient or patient's legal representative signs an EC/ IRB approved informed consent form prior to the study participation Intraprocedural inclusion: GLYCAR Pericardial Patch was implanted, or implantation attempted during the index procedure. Exclusion Criteria: No study specific exclusion criteria: patients treated per standard clinical practice and do not present any of the contraindications detailed in the IFU.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adult and pediatric patients<br>Undergoing cardiac and/or vascular repair or reconstruction surgery | Device: GLYCAR Pericardial Patch<br>* The Glycar patches are intended to be used by surgeons specialized in the field of cardiovascular surgery. The patch is intended to be used for pericardial closure, or repair and/or reconstruction of cardiovascular structures by replacing missing tissue, reinforcing weakened tissue and providing extra strength to repair tissue during healing.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Glycar- Pericardial patch related mortality | Patch related mortality at acute follow up will be determined | 30 days post procedure or hospital discharge (whichever comes first) | 
| Incidence of Glycar- Pericardial patch related reintervention | Patch related re-intervention at acute follow up will be determined | 30 days post procedure or hospital discharge (whichever comes first) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Glycar Pericardial patch related mortality | Patch related mortality at long term follow up will be determined | 1- and 2-years post-procedure | 
| Incidence of Glycar Pericardial patch related reinterventions | Patch related reintervetion at long term follow up will be determined | 1- and 2-years post-procedure | 
| Total number of unplanned reoperations required in patients | 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) | 30 days post procedure or hospital discharge (whichever comes first), 1- and 2-years post-procedure | 
| Incidence of thrombus formation | Number of thrombus formed post procedure will be taken in to account | 30 days or hospital discharge (whichever comes first) and 1- and 2- year follow-up | 
| Incidence of Glycar Pericardial Patch related unanticipated adverse events | Incidence rate of unanticipated adverse events reported for this patch during the FU period will be reported | 30 days or hospital discharge (whichever comes first) and 1- and 2-years follow-up | 
| Rate of detected Patch infection (such as endocarditis) | Any patch related infection rate will be analyzed | 30 days or hospital discharge (whichever comes first) and 1- and 2- year follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bovine pericardial patch