RADIANCE (HELI-169)

• Research type

  Research Study

• Full title

  Multi-electrode Radiofrequency Balloon Catheter for the Treatment of Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation

• IRAS ID

  212539

• Contact name

  Stephanie Plaza

• Contact email

  splaza@its.jnj.com

• Sponsor organisation

  Biosense Webster, Inc

• Duration of Study in the UK

  0 years, 7 months, 31 days

• Research summary

  This interventional study is a prospective, multicenter, single-arm, early feasibility clinical evaluation utilizing the Biosense Webster Multi-electrode RF Balloon Catheter. Subjects will be evaluated pre-procedure, pre-discharge, 7 days post-ablation, and at 1 and 3 months post-ablation.

  The objective of this study is to evaluate the design concept in terms of utility and safety for the Biosense Webster Multi-electrode Radiofrequency Balloon Catheter in the treatment of drug refractory symptomatic Paroxysmal Atrial Fibrillation (PAF) during standard electrophysiology mapping and radiofrequency ablation procedures.

• REC name

  Yorkshire & The Humber - Sheffield Research Ethics Committee

• REC reference

  16/YH/0424

• Date of REC Opinion

  18 Nov 2016

• REC opinion

  Further Information Favourable Opinion