Congenital Premature Cardiac ClosureCIP002NCT05661981
GLYCAR Post Market Multicenter Study
An observational study of Congenital Premature Cardiac Closure and Cardiac and Great Vessel Reconstruction and Repair, run by GLYCAR SA (Pty) Ltd at 4 sites in 2 countries.
Trial summary
Prospective, non-interventional, observational, multi-center, single arm, post market clinical follow-up study Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Congenital Premature Cardiac Closure, Cardiac and Great Vessel Reconstruction and Repair, Peripheral Vascular Reconstruction and Repair
- What is being tested?
- GLYCAR Pericardial Patch
- Type of treatment
- Medical device
- How many people
- 110 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 9 Oct 2023to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- No study specific exclusion criteria: patients treated per standard clinical practice and do not present any of the contraindications detailed in the IFU.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Germany3 sites
Leipzig Heart Institute GmbH
Leipzig
German Heart Center Munich (Deutsches Herzzentrum München)- Adult Section
Munich
German Heart Center Munich (Deutsches Herzzentrum München)- Pediatric Section
Munich
About this study
Official title: A Post Market Multicenter Clinical Investigation of GLYCAR Bovine Pericardial Patch With EnCap™ Technology in Cardiac and Vascular Repair or Reconstruction Surgery. GLYCAR Study
Prospective, non-interventional, observational, multi-center, single arm, post market clinical follow-up study
Read the 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.
- Conditions
- Congenital Premature Cardiac Closure, Cardiac and Great Vessel Reconstruction and Repair, Peripheral Vascular Reconstruction and Repair
- Being tested
- GLYCAR Pericardial Patch
- Keywords
- Bovine pericardial patch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLYCAR Pericardial PatchDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Adult and pediatric patients | Undergoing cardiac and/or vascular repair or reconstruction surgery Receives: Device: GLYCAR Pericardial Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Glycar- Pericardial patch related mortality
Patch related mortality at acute follow up will be determined
Measured: 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
Measured: 30 days post procedure or hospital discharge (whichever comes first)
Secondary outcomes (6)
Incidence of Glycar Pericardial patch related mortality
Patch related mortality at long term follow up will be determined
Measured: 1- and 2-years post-procedure
Incidence of Glycar Pericardial patch related reinterventions
Patch related reintervetion at long term follow up will be determined
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 30 days or hospital discharge (whichever comes first) and 1- and 2- year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start9 Oct 2023
- Primary completionJun 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Congenital Premature Cardiac ClosureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GLYCAR SA (Pty) Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Julien Guihaire, Principal investigator, Cardiac Surgeon, Head of Heart Transplantation and Mechanical Circulatory Support Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05661981
- Sponsor's protocol ID
- GLYCAR
- Acronym
- CIP002
- Status last verified
- Jun 2025
- First submitted
- 7 Dec 2022
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 21276709Mei 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.
PubMed 33330673Bianchi 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.
PubMed 24065756Chlupac 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.
PubMed 35328732Iop 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.
PubMed 30123578Tsai 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.
PubMed 19059755Chlupac 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.
PubMed 20131930Edenfield 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.
PubMed 31492613Burla 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.
PubMed 32607839
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post Market Multicenter Clinical Investigation of GLYCAR Bovine Pericardial Patch With EnCap™ Technology in Cardiac and Vascular Repair or Reconstruction Surgery. GLYCAR Study
- ClinicalTrials.gov ID
- NCT05661981
- Acronym / sponsor ID
- CIP002 / GLYCAR
- Conditions
- Congenital Premature Cardiac Closure, Cardiac and Great Vessel Reconstruction and Repair, Peripheral Vascular Reconstruction and Repair
- Keywords
- Bovine pericardial patch
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- GLYCAR SA (Pty) LtdIndustry (pharma, biotech, devices)
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 22 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult and pediatric patients | – | Device: GLYCAR Pericardial PatchUndergoing cardiac and/or vascular repair or reconstruction surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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
- GLYCAR Pericardial Patch was implanted, or implantation attempted during the index procedure.
Key exclusion criteria (1 listed)
- No study specific exclusion criteria: patients treated per standard clinical practice and do not present any of the contraindications detailed in the IFU.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GLYCAR Pericardial PatchThe 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. | Device | Adult and pediatric patients |
Primary outcome
Incidence of Glycar- Pericardial patch related mortality
Time frame: 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
Time frame: 30 days post procedure or hospital discharge (whichever comes first)
Patch related re-intervention at acute follow up will be determined
6 secondary outcomes
Incidence of Glycar Pericardial patch related mortality
Time frame: 1- and 2-years post-procedure
Incidence of Glycar Pericardial patch related reinterventions
Time frame: 1- and 2-years post-procedure
Total number of unplanned reoperations required in patients
Time frame: 30 days post procedure or hospital discharge (whichever comes first), 1- and 2-years post-procedure
Incidence of thrombus formation
Time frame: 30 days or hospital discharge (whichever comes first) and 1- and 2- year follow-up
Incidence of Glycar Pericardial Patch related unanticipated adverse events
Time frame: 30 days or hospital discharge (whichever comes first) and 1- and 2-years follow-up
Rate of detected Patch infection (such as endocarditis)
Time frame: 30 days or hospital discharge (whichever comes first) and 1- and 2- year follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Results publication: PubMed 21276709Li 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.
- Results publication: PubMed 33330673Mei 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.
- Results publication: PubMed 24065756Bianchi 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.
- Results publication: PubMed 35328732Chlupac 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.
- Results publication: PubMed 30123578Iop 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.
- Results publication: PubMed 19059755Tsai 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.
- Results publication: PubMed 20131930Chlupac 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.
- Results publication: PubMed 31492613Edenfield 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.
- Results publication: PubMed 32607839Burla 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julien Guihaire principal investigator
Cardiac Surgeon, Head of Heart Transplantation and Mechanical Circulatory Support Program
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Premature Cardiac Closure and Cardiac and Great Vessel Reconstruction and Repair, run by GLYCAR SA (Pty) Ltd at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Glycar- Pericardial patch related mortality (time frame: 30 days post procedure or hospital discharge (whichever comes first)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05661981, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.