TRUE HD

• Research type

  Research Study

• Full title

  Prospective Registry on User Experience With The RHYTHMIATM Mapping System For Ablation Procedures TRUE HD

• IRAS ID

  202796

• Contact name

  Tom Wong

• Contact email

  tom.wong@imperial.ac.uk

• Sponsor organisation

  Boston Scirentific

• Clinicaltrials.gov Identifier

  NCT02698670

• Duration of Study in the UK

  1 years, 2 months, days

• Research summary

  The TRUE HD Study is a post-market study designed to collect real-world data on the use of the RhythmiaTM mapping system System and the IntellaMap OrionTM mapping catheter in patients indicated for an ablation procedure with use of a 3D Mapping system.
  The study will collect specific information on the management of ablation procedures with the system including procedural success, type and amount of arrhythmias mapped/treated, and how the mapping system is used overall.

• REC name

  East of Scotland Research Ethics Service REC 1

• REC reference

  16/ES/0063

• Date of REC Opinion

  27 Apr 2016

• REC opinion

  Favourable Opinion