An observational study in Intracardiac and Septal Defects, Valve and Anulus Repair and Great Vessel Reconstruction, sponsored by LeMaitre Vascular. Active, not recruiting at 6 sites in 4 countries. Per ClinicalTrials.gov, last updated 2025-03-10.
Sponsored by LeMaitre Vascular · Observational
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.
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:
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.
82 studies on the registry are indexed under Heart Septal Defects; 9 are open to participants now.
This study's planned enrollment of 200 is above the median of 75 across 24 observational studies indexed under Heart Septal Defects.
Browse Heart Septal Defects studies →LeMaitre Vascular is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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
Device: CardioCel implantation
treatment of intracardiac defects; treatment of septal defects; valve and annulus repair; great vessel reconstruction; peripheral vascular reconstruction; suture line buttressing
Incidence of graft related reintervention
capture the rate of graft related reintervention
Time frame: 30 days post procedure.
Incidence of patch related morbidity
capture the rate of patch related morbidity
Time frame: 30 days post procedure
Incidence of graft related reinterventions
capture the rate of graft related reinterventions
Time frame: at 1 and 2 years post-procedure
Rates of Valvular Regurgitation Grade > Moderate
for Valve and annulus repair
Time frame: 30 days post procedure
Rates of re-stenosis
for Great vessel reconstruction
Time frame: at 30 days and 1 and 2 years follow-up
Rates of recoarctation
for Great vessel reconstruction
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
for Peripheral vascular reconstruction
Time frame: at 30 days and 1 and 2 years follow-up
incidence of Patch dehiscence
capturing the rate of patch dehiscence
Time frame: at 30 days and 1 and 2 years follow-up
Incidence of Patch calcification
capturing the rate of patch calcification
Time frame: at 30 days and 1 and 2 years follow-up
Incidence of Patch retraction
capturing the rate of patch retraction
Time frame: at 30 days and 1 and 2 years follow-up
Incidence of Unanticipated events
capturing the rate of unanticipated events
Time frame: at 30 days and 1 and 2 years follow-up
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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LeMaitre Vascular