GLYCAR Post Market Multicenter Study

N/AActive Not RecruitingNCT05661981

GLYCAR SA (Pty) Ltd110 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

110

Conditions

Congenital Premature Cardiac Closure Cardiac and Great Vessel Reconstruction and Repair Peripheral Vascular Reconstruction and Repair

Interventions

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (4)

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

Outcomes

Primary Outcomes

Incidence of Glycar- Pericardial patch related mortality

Patch related mortality at acute follow up will be determined

Time frame: 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

Time frame: 30 days post procedure or hospital discharge (whichever comes first)

Secondary Outcomes

Incidence of Glycar Pericardial patch related mortality

Patch related mortality at long term follow up will be determined

Time frame: 1- and 2-years post-procedure

Incidence of Glycar Pericardial patch related reinterventions

Patch related reintervetion at long term follow up will be determined

Time frame: 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)

Time frame: 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

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

Data from ClinicalTrials.gov

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