NCT04175327

Prospective and Non-randomized Registry of CardioCel 3D

Post-Market Registry in Europe for the Use of CardioCel®, CardioCel® Neo and CardioCel® 3D

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: LeMaitre Vascular · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Intracardiac and Septal Defects
• Valve and Anulus Repair
• Great Vessel Reconstruction
• Peripheral Vessel Reconstruction
• Suture Line Buttressing

Interventions

Type	Name	Description
DEVICE	CardioCel implantation	treatment of intracardiac defects; treatment of septal defects; valve and annulus repair; great vessel reconstruction; peripheral vascular reconstruction; suture line buttressing

Timeline

• Start date: 2020-08-28
• Primary completion: 2025-11-01
• Completion: 2026-03-01
• First posted: 2019-11-25
• Last updated: 2025-03-10

Locations

6 sites across 4 countries: Germany, Italy, Spain, United Kingdom