VISTAX version 1.0

• Research type

  Research Study

• Full title

  Evaluation of Ablation Index and VISITAG™ use for Pulmonary Vein Isolation (PVI) in Patients with Paroxysmal Atrial Fibrillation (PAF)

• IRAS ID

  220504

• Contact name

  Nathalie Macours

• Contact email

  nmacours1@its.jnj.com

• Sponsor organisation

  BIOSENSE WEBSTER, INC.

• Duration of Study in the UK

  1 years, 7 months, 31 days

• Research summary

  Prospective, non-randomized, post-market clinical evaluation utilizing Ablation
  Index software and VISITAG™ in combination with Thermocool SmartTouch® (ST) or
  SmartTouch Surroundflow® (STSF) catheter.

  The purpose of this study is to see if the use of the Ablation Index program (the investigational device) in combination with the VisitagTM module during your standard ablation procedure may help to identify and improve the outcome of your treatment for your arrhythmia.
  The Visitag™ module tracks the parameters of the ablation procedure and provides visual display by coloring each stable ablation site according to the Ablation Index. The Ablation Index simplifies the monitoring of specific parameters by integrating them in a single number. The additional collected information will be used for research purposes.

• REC name

  Yorkshire & The Humber - Sheffield Research Ethics Committee

• REC reference

  17/YH/0098

• Date of REC Opinion

  7 Jun 2017

• REC opinion

  Further Information Favourable Opinion