Observational study on the Glycar Pericardial patch in heart and vascular surgeries
A Post Market Multicenter Clinical Investigation of GLYCAR Bovine Pericardial Patch With EnCap™ Technology in Cardiac and Vascular Repair or Reconstruction Surgery. GLYCAR Study
GLYCAR SA (Pty) Ltd · NCT05661981
This study is looking at how well the Glycar Pericardial patch works for patients having heart and blood vessel surgeries to see if it helps improve their recovery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 110 (estimated) |
| Sex | All |
| Sponsor | GLYCAR SA (Pty) Ltd (industry) |
| Locations | 4 sites (Le Plessis-Robinson and 3 other locations) |
| Trial ID | NCT05661981 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather real-world evidence on the performance of the Glycar Pericardial patch in patients undergoing cardiac and vascular repair or reconstruction surgeries. It will enroll up to 100 patients across multiple centers in the European Union, South Africa, and the USA. The study will track clinical outcomes and the effectiveness of the patch in these procedures, providing valuable data on its use in standard clinical practice.
Who should consider this trial
Good fit: Ideal candidates for this study are patients scheduled for cardiac or vascular surgery who will receive the Glycar Pericardial patch as part of their treatment.
Not a fit: Patients who are not undergoing cardiac or vascular repair surgeries or those who do not meet the standard clinical practice criteria for the Glycar Pericardial patch may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of the Glycar Pericardial patch's effectiveness, potentially leading to improved surgical outcomes for patients undergoing cardiac and vascular repairs.
How similar studies have performed: While this study is observational and focuses on a specific device, similar studies have shown success in evaluating the performance of medical devices in real-world settings.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Le Plessis-Robinson and 3 other locations
- Marie Lannelongue Hospital — Le Plessis-Robinson, France (RECRUITING)
- Leipzig Heart Institute GmbH — Leipzig, Germany (RECRUITING)
- German Heart Center Munich (Deutsches Herzzentrum München)- Adult Section — Munich, Germany (RECRUITING)
- German Heart Center Munich (Deutsches Herzzentrum München)- Pediatric Section — Munich, Germany (RECRUITING)
Study contacts
- Principal investigator: Julien Guihaire — Cardiac Surgeon, Head of Heart Transplantation and Mechanical Circulatory Support Program
- Study coordinator: Danielle Avadis
- Email: danielle@glycar.co.za
- Phone: +27 12 667 16 15
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Congenital Premature Cardiac Closure, Cardiac and Great Vessel Reconstruction and Repair, Peripheral Vascular Reconstruction and Repair, Bovine pericardial patch