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Active, Not Recruiting

NCT Number: NCT04175327

Prospective and Non-randomized Registry of 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Intracardiac and Septal Defects Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Great Vessel Reconstruction Heart Defects, Congenital Heart Diseases Heart Septal Defects Peripheral Vessel Reconstruction Suture Line Buttressing Valve and Anulus Repair

Sex eligibility

All sexes

Study type

Observational

Primary location

Heart Center Leipzig, Leipzig, Germany

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CardioCel implantation

Device

treatment of intracardiac defects; treatment of septal defects; valve and annulus repair; great vessel reconstruction; peripheral vascular reconstruction; suture line buttressing

Primary outcomes

  1. Incidence of graft related reintervention

    Time frame: 30 days post procedure.

    capture the rate of graft related reintervention

  2. Incidence of patch related morbidity

    Time frame: 30 days post procedure

    capture the rate of patch related morbidity

Secondary outcomes

  1. Incidence of graft related reinterventions

    Time frame: at 1 and 2 years post-procedure

    capture the rate of graft related reinterventions

  2. Rates of Valvular Regurgitation Grade > Moderate

    Time frame: 30 days post procedure

    for Valve and annulus repair

  3. Rates of re-stenosis

    Time frame: at 30 days and 1 and 2 years follow-up

    for Great vessel reconstruction

  4. Rates of recoarctation

    Time frame: at 30 days and 1 and 2 years follow-up

    for Great vessel reconstruction

  5. 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

    for Peripheral vascular reconstruction

  6. incidence of Patch dehiscence

    Time frame: at 30 days and 1 and 2 years follow-up

    capturing the rate of patch dehiscence

  7. Incidence of Patch calcification

    Time frame: at 30 days and 1 and 2 years follow-up

    capturing the rate of patch calcification

  8. Incidence of Patch retraction

    Time frame: at 30 days and 1 and 2 years follow-up

    capturing the rate of patch retraction

  9. Incidence of Unanticipated events

    Time frame: at 30 days and 1 and 2 years follow-up

    capturing the rate of unanticipated events

Sponsors and collaborators

Lead sponsor

LeMaitre Vascular

Industry

Collaborators

  • Factory CRO for Medical Devices B.V.

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Nov 25, 2019
Registry last updated
Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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