NCT04175327

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.

Trial Health

58
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2020

Longer than P75 for all trials

Geographic Reach
4 countries

6 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 25, 2019

Completed
9 months until next milestone

Study Start

First participant enrolled

August 28, 2020

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

March 10, 2025

Status Verified

March 1, 2025

Enrollment Period

5.2 years

First QC Date

November 19, 2019

Last Update Submit

March 7, 2025

Conditions

Intracardiac and Septal DefectsValve and Anulus RepairGreat Vessel ReconstructionPeripheral Vessel ReconstructionSuture Line Buttressing

Outcome Measures

Primary Outcomes (2)

  • Incidence of graft related reintervention

    capture the rate of graft related reintervention

    30 days post procedure.

  • Incidence of patch related morbidity

    capture the rate of patch related morbidity

    30 days post procedure

Secondary Outcomes (9)

  • Incidence of graft related reinterventions

    at 1 and 2 years post-procedure

  • Rates of Valvular Regurgitation Grade > Moderate

    30 days post procedure

  • Rates of re-stenosis

    at 30 days and 1 and 2 years follow-up

  • Rates of recoarctation

    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

    at 30 days and 1 and 2 years follow-up

  • +4 more secondary outcomes

Study Arms (1)

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

Interventions

CardioCel implantationDEVICE

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

CardioCel group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Heart Center Leipzig

Leipzig, 04289, Germany

Location

Policlinico San Donato

San Donato Milanese, MI, 20097, Italy

Location

A.O.U. Città della Salute e della Scienza

Turin, 10126, Italy

Location

Hospital Universitario "Doce de Octubre"

Madrid, 28041, Spain

Location

Bristol Children's Hospital and the Heart Institute

Bristol, United Kingdom

Location

The Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle, NE7 7DN, United Kingdom

Location

MeSH Terms

Conditions

Heart Septal Defects

Condition Hierarchy (Ancestors)

Heart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Ioana Ghiu

    Anteris

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2019

First Posted

November 25, 2019

Study Start

August 28, 2020

Primary Completion

November 1, 2025

Study Completion

March 1, 2026

Last Updated

March 10, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(2)GB(2)ES(1)DE(1)