Patient Specific Optimized Therapy (PSOT) - Protocol V4

• Research type

  Research Study

• Full title

  Patient Specific Optimized Therapy (PSOT) Study

• IRAS ID

  247800

• Contact name

  G. André Ng

• Contact email

  gan1@le.ac.uk

• Sponsor organisation

  EPD Solutions, a Philips Company

• Clinicaltrials.gov Identifier

  NCT03619018

• Duration of Study in the UK

  5 years, 0 months, 1 days

• Research summary

  Prospective, multi-center, non-randomized, open label, single arm study. Consented subjects who are scheduled to undergo ablation due to arrhythmia will be enrolled in the study. Data will be collected from all subjects during the ablation procedure and post procedure for a period of 36 months.
  KODEX - EPD™ system will be used in all procedures during treatment of cardiac arrhythmias. Anonymized data will be stored in an EPD database and will be used to train and test predictors for personalized optimized therapy.

  The purpose of this study is to collect data with the KODEX system, during the procedure, to analyze and optimize the therapy in the future. The patient will undergo ablation as planned .
  

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  18/EM/0271

• Date of REC Opinion

  18 Jan 2021

• REC opinion

  Further Information Favourable Opinion