The ShortCut™ Study Protocol

• Research type

  Research Study

• Full title

  Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Clinical Study to Demonstrate the Safety and Effectiveness of the ShortCut™ device (The ShortCut™ Study).

• IRAS ID

  302286

• Contact name

  Yael Kislev

• Contact email

  yaelk@pi-cardia.net

• Sponsor organisation

  Pi-Cardia Ltd.

• Clinicaltrials.gov Identifier

  NCT04952909

• Duration of Study in the UK

  2 years, 0 months, 1 days

• Research summary

  40 patients in up to 9 sites in Europe will be enrolled in the study. Participation time will take approximately 3 months.
  Data will be collected at screening, baseline, index procedure, pre-discharge from hospital and at 30 and 90 days post procedure. In the event a patient experienced a neurological event within 30 days post index procedure, a visit at 90 days after the onset of the event will be performed, in order to define whether the event is a disabling or non-disabling.
  All adverse events will be collected throughout the course of the study.
  Results of all patients undergoing the procedure will be collected, analyzed and reported.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  21/LO/0662

• Date of REC Opinion

  18 Oct 2021

• REC opinion

  Further Information Favourable Opinion