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Completed

NCT Number: NCT06088680

Post Market Observational Retrospective Study of Glycar Bovine Pericardial Patch (CIP-003)

The overall purpose of this observational Post Market Clinical Follow Up (PMCF) study is to ensure continued acceptability of the benefit risk ratio by assessment of safety and performance, in patients undergoing cardiovascular repair or reconstruction surgery under standard clinical care with the commercially available Glycar Pericardial Patch.

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Key information

Conditions

Cardiac Defect Cardiac Anomaly Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Pericardial Defect

Sex eligibility

All sexes

Study type

Observational

Primary location

Red Cross War Memorial Children's Hospital

Cape Town, Rondebosch, 7700, South Africa

About this study

To comply with Medical Device Regulation (MDR) Post Market Clinical Follow Up (PMCF) requirements through proactive ongoing assessment of the safety, efficacy, and performance of the commercially available Glycar Pericardial Patch in patients undergoing cardiovascular repair or reconstruction surgery.

This real-world evidence retrospective data collection single-arm multicentre, observational, non-interventional study will enrol up to a minimum of 50 consecutive participants who meet inclusion criteria, in 2-3 centres. The study is aimed at providing real-world evidence of the Glycar Pericardial patch.

Retrospective data analysis will include collected clinical data from consecutive participants with a minimum of 2 years follow up, meaning from 30 June 2020 and going back in time. The quality of medical history being recorded is believed to be more reliable and complete in the most recent years. Therefore, it was decided to start enrolling consecutive participants in a reverse chronological order.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • If no waiver has been granted by the Ethics committee: Participants (all age) or legal guardian has signed the informed consent
  • Participant has undergone a cardiac or vascular procedure which falls within the indications for use and required the use of Glycar Pericardial Patch

Exclusion criteria

  • There are no study specific exclusion criteria. Participants have already been treated per standard clinical practice.

Treatment and study plan

GLYCAR Pericardial Patch

Device

Glycar Bovine pericardial patch with AldeCaptm Technology (aka SJM with EnCaptm technology)

Primary outcomes

  1. Reintervention

    Time frame: Within < 30 days post procedure

    Incidence of patch related reintervention

  2. Mortality

    Time frame: Within < 30 days post procedure

    Incidence of patch related mortality

Secondary outcomes

  1. Reintervention

    Time frame: Up to 2 years

    Incidence of patch related reintervention

  2. Mortality

    Time frame: Up to 2 years

    Incidence of patch related mortality

  3. Infection

    Time frame: Up to 2 years

    Rate of occurrence of Patch infection (such as endocarditis)

  4. Thrombus formation

    Time frame: Within < 30 days post procedure

    Incidence of thrombus formation

  5. Unplanned reoperations

    Time frame: Up to 2 years

    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

  6. Unanticipated AEs

    Time frame: Up to 2 years

    Incidence of patch Unanticipated Adverse Events

Sponsors and collaborators

Lead sponsor

GLYCAR SA (Pty) Ltd

Industry

Registry information

Official study title

A Post Market Multicentre Retrospective Study of Glycar Bovine Pericardial Patch With AldeCaptm Technology (Aka SJM With EnCaptm Technology) in Cardiac and Vascular Repair or Reconstruction Surgery (CIP-003)

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 18, 2023
Registry last updated
Jun 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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