Registry Database for Improved heArt preservatioN, version 1

• Research type

  Research Study

• Full title

  Global Utilisation And Registry Database for Improved heArt preservatioN (GUARDIAN)

• IRAS ID

  288453

• Contact name

  Rajamiyer Venkateswaran

• Contact email

  rajamiyer.venkateswaran@mft.nhs.uk

• Sponsor organisation

  Paragonix Technologies, Inc

• Clinicaltrials.gov Identifier

  NCT04141605

• Duration of Study in the UK

  5 years, 2 months, 31 days

• Research summary

  Study Objective: The objective of this registry is to collect and evaluate various clinical effectiveness parameters in patients with transplanted donor hearts that were preserved and transported within the SherpaPak Cardiac Transport System, as well as retrospective standard of care patients.

  Device: SherpaPak : Preservation of donor organs is a crucial component
  for the maintenance of viability after explantation. The current
  standard for transporting a donor organ includes the storage in
  preservation solution within sequential plastic bags that are
  placed on ice. A potential issue associated with this method of
  storage is a too low temperature leading to tissue injury. Former
  studies could show that the perfect temperature to avoid graft
  injury is between 4° and 8°C. Therefore, Paragonix Technologies
  has developed a medical device keeping the temperature stable
  between this range

  Study Design: GUARDIAN is a post-market, observational registry of adult and pediatric heart transplant recipient patients whose donor heart was preserved and transported within the SherpaPak Cardiac Transport System. The data is being collected retrospectively from medical records of patients already transplanted before the initiation of the registry and any new patients who meet the eligibility criteria.

  Regulatory Status: Post-market evaluation. The SherpaPak Cardiac Transport System utilized in this registry is cleared for marketing by the FDA and is CE Marked for the intended use under study.

  Study Population: Globally, About 500 male and female subjects (including pediatric patients) meeting the study inclusion and exclusion criteria will be enrolled into the study.

  Study Center(s): Globally, about 25 clinical sites will be included within this registry.

  Treatment Plan: Primary heart transplant candidates and retrospective patients will be screened for study eligibility. Every eligible candidate will be asked to participate. Donor hearts will be evaluated for suitability for transplantation and study eligibility. Eligible heart transplant candidates will be enrolled consecutively as they present at each site and will receive donor hearts preserved using the SherpaPak Cardiac Transport System.

  FOLLOW-UP PERIOD: All subjects will be followed through 1-year following recipient transplant (e.g., 24 hours, 30-days, 1-year).

  Study Duration:On-going data collection through five years.

  Primary Outcome Measures: Collection and analysis of clinical and laboratory data from donor and transplant recipient subjects of which donor hearts were transported using the SherpaPak Cardiac Transport System and other methods.

• REC name

  North East - Newcastle & North Tyneside 1 Research Ethics Committee

• REC reference

  21/NE/0121

• Date of REC Opinion

  6 Sep 2021

• REC opinion

  Further Information Favourable Opinion