GLYCAR Post Market Multicenter Study

Last updated: March 19, 2025
Sponsor: GLYCAR SA (Pty) Ltd
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

GLYCAR Pericardial Patch

Clinical Study ID

NCT05661981
GLYCAR
  • All Genders

Study Summary

Prospective, non-interventional, observational, multi-center, single arm, post market clinical follow-up study

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients (to be) treated with Glycar Pericardial patch as per IFU and standardclinical practice.

  • The patient or patient's legal representative signs an EC/ IRB approved informedconsent form prior to the study participation

Intraprocedural inclusion:

GLYCAR Pericardial Patch was implanted, or implantation attempted during the index procedure.

Exclusion

Exclusion Criteria:

  • No study specific exclusion criteria: patients treated per standard clinicalpractice and do not present any of the contraindications detailed in the IFU.

Study Design

Total Participants: 110
Treatment Group(s): 1
Primary Treatment: GLYCAR Pericardial Patch
Phase:
Study Start date:
October 09, 2023
Estimated Completion Date:
March 31, 2027

Study 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.

Connect with a study center

  • Marie Lannelongue Hospital

    Le Plessis-Robinson,
    France

    Active - Recruiting

  • Leipzig Heart Institute GmbH

    Leipzig,
    Germany

    Active - Recruiting

  • German Heart Center Munich (Deutsches Herzzentrum München)- Adult Section

    Munich,
    Germany

    Active - Recruiting

  • German Heart Center Munich (Deutsches Herzzentrum München)- Pediatric Section

    Munich,
    Germany

    Active - Recruiting

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