Cardiac DefectNCT06088680

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

An observational study of Cardiac Defect and Cardiac Anomaly, run by GLYCAR SA (Pty) Ltd at 1 site in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Any age
Conditions the study is for: Cardiac Defect, Cardiac Anomaly, Pericardial Defect
What is being tested?: Glycar Pericardial Patch
Type of treatment: Medical device
How many people: 50 participants
Where: 1 siteSouth Africa
Study dates: 26 Sep 2023to 3 Jun 2024
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

South Africa1 site

Red Cross War Memorial Children's Hospital
Cape Town, Rondebosch, 7700

Other trials in South Africa

About this study

Official 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)

Read the detailed 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.

Conditions: Cardiac Defect, Cardiac Anomaly, Pericardial Defect
Being tested: Glycar Pericardial Patch
Medical subject headings: Heart Defects, Congenital

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT06088680
Study group	Role	What they receive
Open Label- Glycar Pericardial Patch		patients undergoing cardiovascular repair or reconstruction surgery under standard clinical care with the commercially available Glycar Pericardial Patch. Receives: Device: Glycar Pericardial Patch

What is being measured

The primary outcome is the main question the study is designed to answer.

Reintervention
Incidence of patch related reintervention
Measured: Within < 30 days post procedure
Mortality
Incidence of patch related mortality
Measured: Within < 30 days post procedure

Secondary outcomes (6)

Reintervention
Incidence of patch related reintervention
Measured: Up to 2 years
Mortality
Incidence of patch related mortality
Measured: Up to 2 years
Infection
Rate of occurrence of Patch infection (such as endocarditis)
Measured: Up to 2 years
Thrombus formation
Incidence of thrombus formation
Measured: Within < 30 days post procedure
Unplanned reoperations
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
Measured: Up to 2 years
Unanticipated AEs
Incidence of patch Unanticipated Adverse Events
Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Sep 20233 Jun 2024

First posted18 Oct 2023
Study start26 Sep 2023
Primary completion3 Jun 2024
Study completion3 Jun 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Cardiac DefectStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Retrospective
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06088680
Sponsor's protocol ID: CIP-003
Status last verified: Jun 2024
First submitted: 2 Oct 2023
Last updated: 4 Jun 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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)
ClinicalTrials.gov ID: NCT06088680
Acronym / sponsor ID: CIP-003
Conditions: Cardiac Defect, Cardiac Anomaly, Pericardial Defect
Study type: Observational
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: GLYCAR SA (Pty) LtdIndustry (pharma, biotech, devices)
Study start: 26 Sep 2023 (actual)
Primary completion: 3 Jun 2024 (actual)
Study completion: 3 Jun 2024 (actual)
First posted: 18 Oct 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Case only
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
Open Label- Glycar Pericardial Patch	–	Device: Glycar Pericardial Patchpatients undergoing cardiovascular repair or reconstruction surgery under standard clinical care with the commercially available Glycar Pericardial Patch.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patients undergoing cardiovascular repair or reconstruction surgery under standard clinical care with the commercially available Glycar Pericardial Patch.

Key inclusion criteria (2 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Glycar Pericardial PatchGlycar Bovine pericardial patch with AldeCaptm Technology (aka SJM with EnCaptm technology)	Device	Open Label- Glycar Pericardial Patch

Primary outcome

Reintervention
Time frame: Within < 30 days post procedure
Incidence of patch related reintervention
Mortality
Time frame: Within < 30 days post procedure
Incidence of patch related mortality

6 secondary outcomes

Reintervention
Time frame: Up to 2 years
Mortality
Time frame: Up to 2 years
Infection
Time frame: Up to 2 years
Thrombus formation
Time frame: Within < 30 days post procedure
Unplanned reoperations
Time frame: Up to 2 years
Unanticipated AEs
Time frame: Up to 2 years

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
Individual participant dataSharing planned: No

Related trials for Cardiac Defect

Not yet recruitingObservational study
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RecruitingObservational study
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Active, not recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiac Defect and Cardiac Anomaly, run by GLYCAR SA (Pty) Ltd at 1 site in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reintervention (time frame: Within < 30 days post procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06088680.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.