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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
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.
Age
All ages
Sex
ALL
Healthy Volunteers
No
Marie Lannelongue Hospital
Le Plessis-Robinson, France
Leipzig Heart Institute GmbH
Leipzig, Germany
German Heart Center Munich (Deutsches Herzzentrum München)- Adult Section
Munich, Germany
German Heart Center Munich (Deutsches Herzzentrum München)- Pediatric Section
Munich, Germany
Start Date
October 9, 2023
Primary Completion Date
June 1, 2026
Completion Date
June 1, 2027
Last Updated
June 24, 2025
110
ESTIMATED participants
GLYCAR Pericardial Patch
DEVICE
Lead Sponsor
GLYCAR SA (Pty) Ltd
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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