Prospective and Non-randomized Registry of CardioCel 3D

Active, not recruiting

• Conditions: Intracardiac and Septal Defects; Valve and Anulus Repair; Peripheral Vessel Reconstruction; Great Vessel Reconstruction; Suture Line Buttressing
• Interventions: Device: CardioCel implantation

• Registration Number: NCT04175327
• Lead Sponsor: LeMaitre Vascular

Brief 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.

Study Timeline

• Study First Submitted: 2019-11-19
• Study First Submitted QC: 2019-11-21
• Study First Posted: 2019-11-25
• Study Start: 2020-08-28
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-07
• Last Update Posted: 2025-03-10
• Primary Completion: 2025-11
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CardioCel group	CardioCel implantation	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

Primary Outcome Measures

Name	Time	Method
Incidence of graft related reintervention	30 days post procedure.	capture the rate of graft related reintervention
Incidence of patch related morbidity	30 days post procedure	capture the rate of patch related morbidity

Secondary Outcome Measures

Name	Time	Method
Incidence of graft related reinterventions	at 1 and 2 years post-procedure	capture the rate of graft related reinterventions
incidence of Patch dehiscence	at 30 days and 1 and 2 years follow-up	capturing the rate of patch dehiscence
Rates of recoarctation	at 30 days and 1 and 2 years follow-up	for Great vessel reconstruction
Rates of measurement of the dynamic flow by facility standard of care ≥110-175* cm/sec for peripheral vascular locations	at 30 days and 1 and 2 years follow-up	for Peripheral vascular reconstruction
Incidence of Unanticipated events	at 30 days and 1 and 2 years follow-up	capturing the rate of unanticipated events
Rates of Valvular Regurgitation Grade > Moderate	30 days post procedure	for Valve and annulus repair
Rates of re-stenosis	at 30 days and 1 and 2 years follow-up	for Great vessel reconstruction
Incidence of Patch calcification	at 30 days and 1 and 2 years follow-up	capturing the rate of patch calcification
Incidence of Patch retraction	at 30 days and 1 and 2 years follow-up	capturing the rate of patch retraction

Trial Locations

Locations (6)

Heart Center Leipzig; 🇩🇪 Leipzig, Germany

Policlinico San Donato; 🇮🇹 San Donato Milanese, MI, Italy

A.O.U. Città della Salute e della Scienza; 🇮🇹 Turin, Italy

Hospital Universitario "Doce de Octubre"; 🇪🇸 Madrid, Spain

Bristol Children's Hospital and the Heart Institute; 🇬🇧 Bristol, United Kingdom

The Newcastle upon Tyne Hospitals NHS Foundation Trust; 🇬🇧 Newcastle, United Kingdom