NCT06088680

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 26, 2023

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 2, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 18, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2024

Completed
Last Updated

June 4, 2024

Status Verified

June 1, 2024

Enrollment Period

8 months

First QC Date

October 2, 2023

Last Update Submit

June 3, 2024

Conditions

Cardiac DefectCardiac AnomalyPericardial Defect

Outcome Measures

Primary Outcomes (2)

  • Reintervention

    Incidence of patch related reintervention

    Within < 30 days post procedure

  • Mortality

    Incidence of patch related mortality

    Within < 30 days post procedure

Secondary Outcomes (6)

  • Reintervention

    Up to 2 years

  • Mortality

    Up to 2 years

  • Infection

    Up to 2 years

  • Thrombus formation

    Within < 30 days post procedure

  • Unplanned reoperations

    Up to 2 years

  • +1 more secondary outcomes

Study Arms (1)

Open Label- Glycar Pericardial Patch

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

Device: Glycar Pericardial Patch

Interventions

Glycar Pericardial PatchDEVICE

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

Open Label- Glycar Pericardial Patch

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Red Cross War Memorial Children's Hospital

Cape Town, Rondebosch, 7700, South Africa

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2023

First Posted

October 18, 2023

Study Start

September 26, 2023

Primary Completion

June 3, 2024

Study Completion

June 3, 2024

Last Updated

June 4, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

ZA(1)