Intracardiac and Septal DefectsNCT04175327
Prospective and Non-randomized Registry of CardioCel 3D
An observational study of Intracardiac and Septal Defects and Valve and Anulus Repair, run by LeMaitre Vascular at 6 sites in 4 countries.
Trial summary
Post-market, prospective, multi-centre, open-label, registry designed to collect prospective safety and performance data on the use of CardioCel in patients with cardiovascular disorders and in accordance with local standard of care. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intracardiac and Septal Defects, Valve and Anulus Repair, Great Vessel Reconstruction
- What is being tested?
- CardioCel implantation
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 28 Aug 2020to Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: CardioCel, CardioCel Neo and CardioCel 3D are indicated for the repair of cardiac and vascular defects including intracardiac defects; septal defects, valve and annulus repair; great vessel reconstruction, peripheral vascular reconstruction and suture line buttressing.
Who may be able to join
- patient has signed the informed consent
- patient is a candidate for treatment with CardioCel/CardioCel Neo/CardioCel 3D per approved device indications.
Who cannot join
- no study specific exclusion criteria; patients treated per standard clinical practice
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Italy2 sites
Policlinico San Donato
San Donato Milanese, MI, 20097
A.O.U. Città della Salute e della Scienza
Turin, 10126
United Kingdom2 sites
Bristol Children's Hospital and the Heart Institute
Bristol
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle, NE7 7DN
About this study
Official title: Post-Market Registry in Europe for the Use of CardioCel®, CardioCel® Neo and CardioCel® 3D
Post-market, prospective, multi-centre, open-label, registry designed to collect prospective safety and performance data on the use of CardioCel in patients with cardiovascular disorders and in accordance with local standard of care.
The Registry will collect data with a minimum of 50 subjects per major indication (minimum total of 200) in 5-10 sites in Europe. The clinical investigation will maintain data for each patient from the date of implant through 2 years post-implantation.
Read the detailed description
Post-market, prospective, multi-centre, open-label, registry designed to collect prospective safety and performance data on the use of CardioCel in patients with cardiovascular disorders and in accordance with local standard of care. The Registry has been designed to collect prospective product safety and performance data after the CardioCel line extension for CardioCel 3D and the indication expansion to include great vessel and peripheral reconstruction and suture line buttressing and will collect safety and performance data up to 2 years following implantation. The CardioCel 3D Registry will collect data on the use of the CardioCel,
CardioCel Neo and CardioCel 3D for the following major indications:
- Intracardiac and septal defects
- Valve and annulus repair
- Great vessel reconstruction
- Peripheral vascular reconstruction
As suture line buttressing is a procedure that does not consistently use tissue, data on this indication will only be included if available. Data will be prospectively collected by the sites on registry-specific electronic case report forms (eCRFs). The primary endpoints will assess devices' safety and performance through measures and images obtained via the facility's standard of care at the respective registry site. Additional data will also be collected from the implant procedure to assess user (surgeon) satisfaction with the devices' handling and performance.
- Conditions
- Intracardiac and Septal Defects, Valve and Anulus Repair, Great Vessel Reconstruction, Peripheral Vessel Reconstruction, Suture Line Buttressing
- Being tested
- CardioCel implantation
- Medical subject headings
- Heart Septal Defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardioCel implantationDevice
treatment of intracardiac defects; treatment of septal defects; valve and annulus repair; great vessel reconstruction; peripheral vascular reconstruction; suture line buttressing
| Study group | Role | What they receive |
|---|---|---|
| CardioCel group | Patients who require repair of cardiac and vascular defects including intracardiac defects; septal defects, valve and annulus repair; great vessel reconstruction, peripheral vascular reconstruction and suture line buttressing Receives: Device: CardioCel implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of graft related reintervention
capture the rate of graft related reintervention
Measured: 30 days post procedure.
Incidence of patch related morbidity
capture the rate of patch related morbidity
Measured: 30 days post procedure
Secondary outcomes (9)
Incidence of graft related reinterventions
capture the rate of graft related reinterventions
Measured: at 1 and 2 years post-procedure
Rates of Valvular Regurgitation Grade > Moderate
for Valve and annulus repair
Measured: 30 days post procedure
Rates of re-stenosis
for Great vessel reconstruction
Measured: at 30 days and 1 and 2 years follow-up
Rates of recoarctation
for Great vessel reconstruction
Measured: at 30 days and 1 and 2 years follow-up
Rates of measurement of the dynamic flow by facility standard of care ≥110-175* cm/sec for peripheral vascular locations
for Peripheral vascular reconstruction
Measured: at 30 days and 1 and 2 years follow-up
incidence of Patch dehiscence
capturing the rate of patch dehiscence
Measured: at 30 days and 1 and 2 years follow-up
Incidence of Patch calcification
capturing the rate of patch calcification
Measured: at 30 days and 1 and 2 years follow-up
Incidence of Patch retraction
capturing the rate of patch retraction
Measured: at 30 days and 1 and 2 years follow-up
Incidence of Unanticipated events
capturing the rate of unanticipated events
Measured: at 30 days and 1 and 2 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study start28 Aug 2020
- Primary completionNov 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracardiac and Septal DefectsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LeMaitre Vascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Factory CRO for Medical Devices B.V.
- Responsible party
- Sponsor
- Investigators
- Ioana Ghiu, Study director, Anteris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04175327
- Sponsor's protocol ID
- GLRA-G010
- Status last verified
- Mar 2025
- First submitted
- 19 Nov 2019
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Registry in Europe for the Use of CardioCel®, CardioCel® Neo and CardioCel® 3D
- ClinicalTrials.gov ID
- NCT04175327
- Acronym / sponsor ID
- GLRA-G010
- Conditions
- Intracardiac and Septal Defects, Valve and Anulus Repair, Great Vessel Reconstruction, Peripheral Vessel Reconstruction, Suture Line Buttressing
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- LeMaitre VascularIndustry (pharma, biotech, devices)
- Collaborators
- Factory CRO for Medical Devices B.V.
- Study start
- 28 Aug 2020 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 25 Nov 2019 (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.
Post-market, prospective, multi-centre, open-label, registry designed to collect prospective safety and performance data on the use of CardioCel in patients with cardiovascular disorders and in accordance with local standard of care.
The Registry will collect data with a minimum of 50 subjects per major indication (minimum total of 200) in 5-10 sites in Europe. The clinical investigation will maintain data for each patient from the date of implant through 2 years post-implantation.
Detailed description
Post-market, prospective, multi-centre, open-label, registry designed to collect prospective safety and performance data on the use of CardioCel in patients with cardiovascular disorders and in accordance with local standard of care. The Registry has been designed to collect prospective product safety and performance data after the CardioCel line extension for CardioCel 3D and the indication expansion to include great vessel and peripheral reconstruction and suture line buttressing and will collect safety and performance data up to 2 years following implantation. The CardioCel 3D Registry will collect data on the use of the CardioCel,
CardioCel Neo and CardioCel 3D for the following major indications:
- Intracardiac and septal defects
- Valve and annulus repair
- Great vessel reconstruction
- Peripheral vascular reconstruction
As suture line buttressing is a procedure that does not consistently use tissue, data on this indication will only be included if available. Data will be prospectively collected by the sites on registry-specific electronic case report forms (eCRFs). The primary endpoints will assess devices' safety and performance through measures and images obtained via the facility's standard of care at the respective registry site. Additional data will also be collected from the implant procedure to assess user (surgeon) satisfaction with the devices' handling and performance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CardioCel group | – | Device: CardioCel implantationPatients who require repair of cardiac and vascular defects including intracardiac defects; septal defects, valve and annulus repair; great vessel reconstruction, peripheral vascular reconstruction and suture line buttressing |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- CardioCel, CardioCel Neo and CardioCel 3D are indicated for the repair of cardiac and vascular defects including intracardiac defects; septal defects, valve and annulus repair; great vessel reconstruction, peripheral vascular reconstruction and suture line buttressing.
Key inclusion criteria (2 listed)
- patient has signed the informed consent
- patient is a candidate for treatment with CardioCel/CardioCel Neo/CardioCel 3D per approved device indications.
Key exclusion criteria (1 listed)
- no study specific exclusion criteria; patients 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 |
|---|---|---|
| CardioCel implantationtreatment of intracardiac defects; treatment of septal defects; valve and annulus repair; great vessel reconstruction; peripheral vascular reconstruction; suture line buttressing | Device | CardioCel group |
Primary outcome
Incidence of graft related reintervention
Time frame: 30 days post procedure.
capture the rate of graft related reintervention
Incidence of patch related morbidity
Time frame: 30 days post procedure
capture the rate of patch related morbidity
9 secondary outcomes
Incidence of graft related reinterventions
Time frame: at 1 and 2 years post-procedure
Rates of Valvular Regurgitation Grade > Moderate
Time frame: 30 days post procedure
Rates of re-stenosis
Time frame: at 30 days and 1 and 2 years follow-up
Rates of recoarctation
Time frame: at 30 days and 1 and 2 years follow-up
Rates of measurement of the dynamic flow by facility standard of care ≥110-175* cm/sec for peripheral vascular locations
Time frame: at 30 days and 1 and 2 years follow-up
incidence of Patch dehiscence
Time frame: at 30 days and 1 and 2 years follow-up
Incidence of Patch calcification
Time frame: at 30 days and 1 and 2 years follow-up
Incidence of Patch retraction
Time frame: at 30 days and 1 and 2 years follow-up
Incidence of Unanticipated events
Time frame: at 30 days and 1 and 2 years follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Individual participant dataSharing planned: No
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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.
Ioana Ghiu study director
Anteris
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracardiac and Septal Defects and Valve and Anulus Repair, run by LeMaitre Vascular at 6 sites in 4 countries.
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: under way, not looking for participants, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy, United Kingdom, Germany, Spain. 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?
This study is still under way. Results are not available in the source record yet.
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?
Incidence of graft related reintervention (time frame: 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?
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 10 Mar 2025.