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

Glycar

Status: Completed

Conditions: Cardiac Anomaly; Cardiac Defect; Pericardial Defect

Treatments: Device: Glycar Pericardial Patch

Study type: Observational

Funder types: Industry

Identifiers

NCT06088680

CIP-003

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

50 participants in 1 patient group

Open Label- Glycar Pericardial Patch

Description:

patients undergoing cardiovascular repair or reconstruction surgery under standard clinical care with the commercially available Glycar Pericardial Patch.

Treatment:

Device: Glycar Pericardial Patch