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Trial record 2 of 347 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.

Tracking Information
First Submitted Date November 19, 2019
First Posted Date November 25, 2019
Last Update Posted Date April 24, 2020
Estimated Study Start Date June 2020
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 21, 2019)
  • Incidence of graft related reintervention [ Time Frame: 30 days post procedure. ]
  • Incidence of patch related morbidity [ Time Frame: 30 days post procedure ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 21, 2019)
  • Incidence of graft related reinterventions [ Time Frame: at 1 and 2 years post-procedure ]
  • Rates of Valvular Regurgitation Grade > Moderate [ Time Frame: 30 days post procedure ]
    for Valve and annulus repair
  • Rates of re-stenosis [ Time Frame: at 30 days and 1 and 2 years follow-up ]
    for Great vessel reconstruction
  • Rates of recoarctation [ Time Frame: at 30 days and 1 and 2 years follow-up ]
    for Great vessel reconstruction
  • 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
  • incidence of Patch dehiscence [ Time Frame: 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 ]
  • Incidence of Patch retraction [ Time Frame: 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title CardioCel 3D Registry
Official Title Post-Market Registry in Europe for the Use of CardioCel®, CardioCel® Neo and CardioCel® 3D
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Intracardiac and Septal Defects
  • Valve and Anulus Repair
  • Great Vessel Reconstruction
  • Peripheral Vessel Reconstruction
  • Suture Line Buttressing
Intervention Device: CardioCel implantation
treatment of intracardiac defects; treatment of septal defects; valve and annulus repair; great vessel reconstruction; peripheral vascular reconstruction; suture line buttressing
Study Groups/Cohorts 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
Intervention: Device: CardioCel implantation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: November 21, 2019)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2024
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
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

Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Not Provided
Contacts
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
Listed Location Countries Germany,   Poland,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT04175327
Other Study ID Numbers GLRA-G010
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Admedus Regen Pty Ltd.
Study Sponsor Admedus Regen Pty Ltd.
Collaborators Factory CRO for Medical Devices B.V.
Investigators
Study Director: Kiran Bhirangi, Dr Admedus
PRS Account Admedus Regen Pty Ltd.
Verification Date April 2020