Valved Grafts PAS

• Research type

  Research Study

• Full title

  Valved Graft Post-Market Clinical Follow-up Study

• IRAS ID

  292040

• Contact name

  Abbott Abbott

• Contact email

  joanne.obeirne@abbott.com

• Sponsor organisation

  Abbott

• Clinicaltrials.gov Identifier

  NCT04754217

• Duration of Study in the UK

  7 years, 0 months, 31 days

• Research summary

  The purpose of this research study is to collect clinical follow-up data demonstrating the safety and performance of the Abbott Valved Grafts in replacing the native or prosthetic aortic valves and ascending aorta. The study does not include any experimental treatments or testing and is designed only to collect information on patients receiving standard of care treatment. The Valved Graft post market clinical follow up study has been designed to meet the post-market clinical follow-up (PMCF) requirements of the EU Medical Device Directive (MDD).

  Participants meeting the eligibility criteria will be approached by their doctor with a PIS. Should the participant make an informed decision to take part in the study, they will provide their written informed consent.

  Data will be collected at initial visits: baseline, procedure, discharge, then at follow ups taking place at one, two, three, four and five years post procedure. At baseline, the following data/ information will be collected:
  • Informed consent process
  • Indication for aortic and ascending aorta replacement
  • Demographics
  • Medical history
  • Cardiac medications
  • Physical examination
  • NYHA classification
  • TEE or TTE, per site standard of care

  At the procedure, the following data will be collected:
  • Procedure characteristics (e.g. surgeon, access approach, CPB time)
  • Abbott Valved Graft device implant
  • Concomitant intervention
  • Adverse Events
  • Cardiac medications

  At the discharge and follow up visits (in person/telephone call), the following data will be collected:
  • Cardiac medications
  • Adverse events
  Additionally at the follow up visits, NHYA classification data will be collected

• REC name

  West Midlands - South Birmingham Research Ethics Committee

• REC reference

  21/WM/0130

• Date of REC Opinion

  1 Sep 2021

• REC opinion

  Further Information Favourable Opinion