Prospective and Non-randomized Registry of CardioCel 3D

February 23, 2024 updated by: LeMaitre Vascular

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Leipzig, Germany, 04289
  • Italy
      • Turin, Italy, 10126
        • Not yet recruiting
        • A.O.U. Città della Salute e della Scienza
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mauro Rinaldi, Prof
        • Sub-Investigator:
          • Claudia Calia, Dr
    • MI
  • Spain
      • Madrid, Spain, 28041
        • Not yet recruiting
        • Hospital Universitario "Doce de Octubre"
        • Contact:
        • Principal Investigator:
          • Lorenzo Boni, Dr
  • United Kingdom
      • Bristol, United Kingdom
        • Recruiting
        • Bristol Children's Hospital and the Heart Institute
        • Contact:
        • Contact:
        • Principal Investigator:
          • Massimo Caputo, Mr
        • Sub-Investigator:
          • Andrew Parry, Mr
        • Sub-Investigator:
          • Shafi Mussa, Mr
      • Newcastle, United Kingdom, NE7 7DN
        • Recruiting
        • The Newcastle upon Tyne Hospitals NHS Foundation Trust
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mohamed Nassar, Mr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CardioCel group
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of graft related reintervention
Time Frame: 30 days post procedure.
capture the rate of graft related reintervention
30 days post procedure.
Incidence of patch related morbidity
Time Frame: 30 days post procedure
capture the rate of patch related morbidity
30 days post procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of graft related reinterventions
Time Frame: at 1 and 2 years post-procedure
capture the rate of graft related reinterventions
at 1 and 2 years post-procedure
Rates of Valvular Regurgitation Grade > Moderate
Time Frame: 30 days post procedure
for Valve and annulus repair
30 days post procedure
Rates of re-stenosis
Time Frame: at 30 days and 1 and 2 years follow-up
for Great vessel reconstruction
at 30 days and 1 and 2 years follow-up
Rates of recoarctation
Time Frame: at 30 days and 1 and 2 years follow-up
for Great vessel reconstruction
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
Time Frame: at 30 days and 1 and 2 years follow-up
for Peripheral vascular reconstruction
at 30 days and 1 and 2 years follow-up
incidence of Patch dehiscence
Time Frame: at 30 days and 1 and 2 years follow-up
capturing the rate of patch dehiscence
at 30 days and 1 and 2 years follow-up
Incidence of Patch calcification
Time Frame: at 30 days and 1 and 2 years follow-up
capturing the rate of patch calcification
at 30 days and 1 and 2 years follow-up
Incidence of Patch retraction
Time Frame: at 30 days and 1 and 2 years follow-up
capturing the rate of patch retraction
at 30 days and 1 and 2 years follow-up
Incidence of Unanticipated events
Time Frame: at 30 days and 1 and 2 years follow-up
capturing the rate of unanticipated events
at 30 days and 1 and 2 years follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LeMaitre Vascular

Collaborators

Factory CRO for Medical Devices B.V.

Investigators

  • Study Director: Ioana Ghiu, Anteris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 28, 2020

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

November 19, 2019

First Submitted That Met QC Criteria

November 21, 2019

First Posted (Actual)

November 25, 2019

Study Record Updates

Last Update Posted (Estimated)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 23, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GLRA-G010

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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