GLYCAR Post Market Multicenter Study

Recruiting

• Conditions: Peripheral Vascular Reconstruction and Repair; Cardiac and Great Vessel Reconstruction and Repair; Congenital Premature Cardiac Closure
• Interventions: Device: GLYCAR Pericardial Patch

• Registration Number: NCT05661981
• Lead Sponsor: GLYCAR SA (Pty) Ltd

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.

Study Timeline

• Study First Submitted: 2022-12-07
• Study First Submitted QC: 2022-12-14
• Study First Posted: 2022-12-22
• Study Start: 2023-10-09
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-19
• Last Update Posted: 2025-03-20
• Primary Completion: 2026-04
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adult and pediatric patients	GLYCAR Pericardial Patch	Undergoing cardiac and/or vascular repair or reconstruction surgery

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Incidence of Glycar Pericardial patch related reinterventions	1- and 2-years post-procedure	Patch related reintervetion at long term follow up will be determined
Incidence of Glycar Pericardial patch related mortality	1- and 2-years post-procedure	Patch related mortality 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
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
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

Trial Locations

Locations (4)

Leipzig Heart Institute GmbH; 🇩🇪 Leipzig, Germany

German Heart Center Munich (Deutsches Herzzentrum München)- Adult Section; 🇩🇪 Munich, Germany

Marie Lannelongue Hospital; 🇫🇷 Le Plessis-Robinson, France

German Heart Center Munich (Deutsches Herzzentrum München)- Pediatric Section; 🇩🇪 Munich, Germany