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

GLYCAR Post Market Multicenter Study

Congenital Premature Cardiac Closure

Cardiac and Great Vessel Reconstruction and Repair

Peripheral Vascular Reconstruction and Repair

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.

GLYCAR Pericardial Patch

A Post Market Multicenter Clinical Investigation of GLYCAR Bovine Pericardial Patch With EnCap™ Technology in Cardiac and Vascular Repair or Reconstruction Surgery. GLYCAR Study

Patch related mortality at acute follow up will be determined

Patch related re-intervention at acute follow up will be determined

Patch related mortality at long term follow up will be determined

Patch related reintervetion at long term follow up will be determined

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)

Number of thrombus formed post procedure will be taken in to account

Incidence rate of unanticipated adverse events reported for this patch during the FU
period will be reported

Any patch related infection rate will be analyzed

Undergoing cardiac and/or vascular repair or reconstruction surgery

GLYCAR Post Market Multicenter Study

About this trial

Study ID

Status

Type

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?