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Prospective, non-interventional, observational, multi-center, single arm, post market clinical follow-up study
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult and pediatric patients | Undergoing cardiac and/or vascular repair or reconstruction surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLYCAR Pericardial Patch | Device | 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. |
| 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) |
| 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 |
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Inclusion Criteria:
Intraprocedural inclusion:
GLYCAR Pericardial Patch was implanted, or implantation attempted during the index procedure.
Exclusion Criteria:
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This real-world, single-arm, multi-center, observational, non-interventional prospective registry will enrol up to a total of 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.
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| Name | Affiliation | Role |
|---|---|---|
| Julien Guihaire | Cardiac Surgeon, Head of Heart Transplantation and Mechanical Circulatory Support Program | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marie Lannelongue Hospital | Le Plessis-Robinson | France | ||||
| Leipzig Heart Institute GmbH |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21276709 | Result | Li X, Guo Y, Ziegler KR, Model LS, Eghbalieh SD, Brenes RA, Kim ST, Shu C, Dardik A. Current usage and future directions for the bovine pericardial patch. Ann Vasc Surg. 2011 May;25(4):561-8. doi: 10.1016/j.avsg.2010.11.007. Epub 2011 Jan 28. | |
| 33330673 | Result | Mei X, Cheng K. Recent Development in Therapeutic Cardiac Patches. Front Cardiovasc Med. 2020 Nov 27;7:610364. doi: 10.3389/fcvm.2020.610364. eCollection 2020. |
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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 |
| Leipzig |
| Germany |
| German Heart Center Munich (Deutsches Herzzentrum München)- Adult Section | Munich | Germany |
| German Heart Center Munich (Deutsches Herzzentrum München)- Pediatric Section | Munich | Germany |
| 24065756 | Result | Bianchi G. eComment. Autologous pericardium is superior to conventional bovine patch in congenital heart disease reconstructive surgery: an appraisal for tissueengineered xenograft. Interact Cardiovasc Thorac Surg. 2013 Oct;17(4):702-3. doi: 10.1093/icvts/ivt368. No abstract available. |
| 35328732 | Result | Chlupac J, Matejka R, Konarik M, Novotny R, Simunkova Z, Mrazova I, Fabian O, Zapletal M, Pulda Z, Lipensky JF, Stepanovska J, Hanzalek K, Broz A, Novak T, Lodererova A, Voska L, Adla T, Fronek J, Rozkot M, Forostyak S, Kneppo P, Bacakova L, Pirk J. Vascular Remodeling of Clinically Used Patches and Decellularized Pericardial Matrices Recellularized with Autologous or Allogeneic Cells in a Porcine Carotid Artery Model. Int J Mol Sci. 2022 Mar 18;23(6):3310. doi: 10.3390/ijms23063310. |
| 30123578 | Result | Iop L, Palmosi T, Dal Sasso E, Gerosa G. Bioengineered tissue solutions for repair, correction and reconstruction in cardiovascular surgery. J Thorac Dis. 2018 Jul;10(Suppl 20):S2390-S2411. doi: 10.21037/jtd.2018.04.27. |
| 19059755 | Result | Tsai JW, Ayubi FS, Rice RD, Zhang Z, Armstrong PJ. Permacol (porcine dermal collagen) and Alloderm (acellular cadaveric dermis) as a vascular patch repair for common carotid arteriotomy in a rabbit model. Ann Vasc Surg. 2009 May-Jun;23(3):374-81. doi: 10.1016/j.avsg.2008.10.004. Epub 2008 Dec 6. |
| 20131930 | Result | Chlupac J, Filova E, Bacakova L. Blood vessel replacement: 50 years of development and tissue engineering paradigms in vascular surgery. Physiol Res. 2009;58 Suppl 2:S119-S140. doi: 10.33549/physiolres.931918. |
| 31492613 | Result | Edenfield L, Blazick E, Eldrup-Jorgensen J, Healey C, Bloch P, Hawkins R, Aranson N, Nolan B. Outcomes of carotid endarterectomy in the Vascular Quality Initiative based on patch type. J Vasc Surg. 2020 Apr;71(4):1260-1267. doi: 10.1016/j.jvs.2019.05.063. Epub 2019 Sep 3. |
| 32607839 | Result | Burla L, Schwegler I, Weibel P, Weber M, Zientara A, Attigah N. Intraoperatively self-made bovine pericardial graft for portomesenteric reconstruction in pancreatic surgery. Langenbecks Arch Surg. 2020 Aug;405(5):705-712. doi: 10.1007/s00423-020-01920-0. Epub 2020 Jun 30. |