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Trial record 2 of 339 for:    The GREAT Registry

CardioCel 3D Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04175327
Recruitment Status : Not yet recruiting
First Posted : November 25, 2019
Last Update Posted : April 24, 2020
Sponsor:
Collaborator:
Factory CRO for Medical Devices B.V.
Information provided by (Responsible Party):
Admedus Regen Pty Ltd.

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.


Condition or disease Intervention/treatment
Intracardiac and Septal Defects Valve and Anulus Repair Great Vessel Reconstruction Peripheral Vessel Reconstruction Suture Line Buttressing Device: CardioCel 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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-Market Registry in Europe for the Use of CardioCel®, CardioCel® Neo and CardioCel® 3D
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : March 2024

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




Primary Outcome Measures :
  1. Incidence of graft related reintervention [ Time Frame: 30 days post procedure. ]
  2. Incidence of patch related morbidity [ Time Frame: 30 days post procedure ]

Secondary Outcome Measures :
  1. Incidence of graft related reinterventions [ Time Frame: at 1 and 2 years post-procedure ]
  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 ]
  7. Incidence of Patch calcification [ Time Frame: at 30 days and 1 and 2 years follow-up ]
  8. Incidence of Patch retraction [ Time Frame: at 30 days and 1 and 2 years follow-up ]
  9. Incidence of Unanticipated events [ Time Frame: at 30 days and 1 and 2 years follow-up ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04175327


Contacts
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Contact: Factory CRO +31 30 229 2727 w.gjaltema@factory-cro.com
Contact: Kiran Bhirangi, Dr +1 651 493 0606 ext 1000 kbhirangi@admedus.com

Locations
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Germany
Heart Center Leipzig
Leipzig, Germany, 04289
Contact: Martin Kostelka, Prof    + 49 341 45291003    martin.kostelka@helios-gesundheit.de   
Principal Investigator: Martin Kostelka, Prof         
Poland
University Children's Hospital Krakow
Kraków, Poland, 30-663
Contact: Tomasz Mroczek, Prof    + 48 6 0133 2217    t_mroczek@hotmail.com   
Principal Investigator: Tomasz Mroczek, Prof         
United Kingdom
Bristol Children's Hospital and the Heart Institute
Bristol, United Kingdom
Contact: Serban Stoica, Mr    +44 75404 88497    serban.stoica@uhbristol.nhs.uk   
Principal Investigator: Serban Stoica, Mr         
Sponsors and Collaborators
Admedus Regen Pty Ltd.
Factory CRO for Medical Devices B.V.
Investigators
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Study Director: Kiran Bhirangi, Dr Admedus
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Responsible Party: Admedus Regen Pty Ltd.
ClinicalTrials.gov Identifier: NCT04175327    
Other Study ID Numbers: GLRA-G010
First Posted: November 25, 2019    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities