Cardiac and Great Vessel Reconstruction and Repair, Congenital Premature Cardiac Closure, Peripheral Vascular Reconstruction and Repair
Conditions
Keywords
Bovine pericardial patch
Brief summary
Prospective, non-interventional, observational, multi-center, single arm, post market clinical follow-up study
Detailed description
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.
Interventions
DEVICEGLYCAR Pericardial Patch
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.
Sponsors
GLYCAR SA (Pty) Ltd
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Glycar- Pericardial patch related mortality | 30 days post procedure or hospital discharge (whichever comes first) | Patch related mortality at acute follow up will be determined |
| Incidence of Glycar- Pericardial patch related reintervention | 30 days post procedure or hospital discharge (whichever comes first) | Patch related re-intervention at acute follow up will be determined |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Glycar Pericardial patch related reinterventions | 1- and 2-years post-procedure | Patch related reintervetion at long term follow up will be determined |
| Total number of unplanned reoperations required in patients | 30 days post procedure or hospital discharge (whichever comes first), 1- and 2-years post-procedure | 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) |
| Incidence of thrombus formation | 30 days or hospital discharge (whichever comes first) and 1- and 2- year follow-up | Number of thrombus formed post procedure will be taken in to account |
| Rate of detected Patch infection (such as endocarditis) | 30 days or hospital discharge (whichever comes first) and 1- and 2- year follow-up | Any patch related infection rate will be analyzed |
| Incidence of Glycar Pericardial Patch related unanticipated adverse events | 30 days or hospital discharge (whichever comes first) and 1- and 2-years follow-up | Incidence rate of unanticipated adverse events reported for this patch during the FU period will be reported |
| Incidence of Glycar Pericardial patch related mortality | 1- and 2-years post-procedure | Patch related mortality at long term follow up will be determined |
Countries
France, Germany
Outcome results
None listed