Clinical trial NCT04175327: Prospective and Non-randomized Registry of CardioCel 3D
Official title: Post-Market Registry in Europe for the Use of CardioCel®, CardioCel® Neo and CardioCel® 3D
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Intracardiac and Septal Defects
Valve and Anulus Repair
Great Vessel Reconstruction
Peripheral Vessel Reconstruction
Suture Line Buttressing
Lead sponsor: LeMaitre Vascular
Sponsor class: INDUSTRY
Collaborators: name: Factory CRO for Medical Devices B.V.
First posted: 2019-11-25
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of graft related reintervention
timeFrame: 30 days post procedure.
measure: Incidence of patch related morbidity
timeFrame: 30 days post procedure
Secondary outcomes:
measure: Incidence of graft related reinterventions
timeFrame: at 1 and 2 years post-procedure
measure: Rates of Valvular Regurgitation Grade > Moderate
timeFrame: 30 days post procedure
measure: Rates of re-stenosis
timeFrame: at 30 days and 1 and 2 years follow-up
measure: Rates of recoarctation
timeFrame: at 30 days and 1 and 2 years follow-up
measure: Rates of measurement of the dynamic flow by facility standard of care ≥110-175* cm/sec for peripheral vascular locations
timeFrame: at 30 days and 1 and 2 years follow-up
measure: incidence of Patch dehiscence
timeFrame: at 30 days and 1 and 2 years follow-up
measure: Incidence of Patch calcification
timeFrame: at 30 days and 1 and 2 years follow-up
measure: Incidence of Patch retraction
timeFrame: at 30 days and 1 and 2 years follow-up
measure: Incidence of Unanticipated events
timeFrame: at 30 days and 1 and 2 years follow-up
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Heart Center Leipzig
city: San Donato Milanese
country: Italy
facility: Policlinico San Donato
state: MI
city: Turin
country: Italy
facility: A.O.U. Città della Salute e della Scienza
city: Madrid
country: Spain
facility: Hospital Universitario "Doce de Octubre"
city: Bristol
country: United Kingdom
facility: Bristol Children's Hospital and the Heart Institute
city: Newcastle
country: United Kingdom
facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust
Study officials:
affiliation: Anteris
name: Ioana Ghiu
role: STUDY_DIRECTOR
References: