SHINE (BWI_2017_01)
Research type
Research Study
Full title
Multi-electrode Radiofrequency Balloon Catheter use for the isolation of the pulmonary veins.
IRAS ID
233641
Contact name
Liesbeth Vanderlinden
Contact email
Sponsor organisation
Biosense Webster, Inc
Duration of Study in the UK
1 years, 6 months, days
Research summary
This clinical investigation is a prospective, multicenter, single arm clinical evaluation utilizing the Biosense Webster multi-electrode radiofrequency balloon catheter and the Biosense Webster multi-electrode circular diagnostic catheter. The objective of this clinical investigation is to assess the safety and acute effectiveness of the multi-electrode radiofrequency balloon catheter and multi-electrode circular diagnostic catheter (Frontera) when used for the isolation of the pulmonary veins in the treatment of Paroxysmal Atrial Fibrillation (PAF). A maximum of 230 evaluable subjects with symptomatic PAF who are candidates for atrial fibrillation ablation will be enrolled in this study, excluding roll-in subjects. Subjects will be evaluated at 7 days, 30 days and 3 months following procedure. 40 subjects will be consented to be included in the Neurological Assessment Evaluable (NAE) subgroup and will undergo additional neurological examinations.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
17/YH/0346
Date of REC Opinion
17 Nov 2017
REC opinion
Further Information Favourable Opinion