Prospective and Non-randomized Registry of CardioCel 3D

LeMaitre Vascular

Status: Active, not recruiting

Conditions: Valve and Anulus Repair; Suture Line Buttressing; Peripheral Vessel Reconstruction; Great Vessel Reconstruction; Intracardiac and Septal Defects

Treatments: Device: CardioCel implantation

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04175327

GLRA-G010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• patient has signed the informed consent
• patient is a candidate for treatment with CardioCel/CardioCel Neo/CardioCel 3D per approved device indications.

Exclusion criteria

• no study specific exclusion criteria; patients treated per standard clinical practice

Trial design

200 participants in 1 patient group

CardioCel group

Description:

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

Treatment:

Device: CardioCel implantation