OCTARAY FIM (BWI_2017_05)
Research type
Research Study
Full title
Clinical evaluation of higher density mapping in complex arrhythmias with the CARTO® OCTARAY™ HD Mapping Catheter
IRAS ID
247486
Contact name
Don Nguyen
Contact email
Sponsor organisation
Biosense Webster, Inc
ISRCTN Number
ISRCTN93591221
Duration of Study in the UK
0 years, 3 months, 26 days
Research summary
The purpose of this study is to assess the performance and safety of the OCTARAY™ catheter in supporting ablation procedures that treat arrhythmias.
The OCTARAY™ catheter is a diagnostic device used to understand and record electrical impulses in various places in a person’s heart. These are the same electric impulses that are recorded by an electrocardiogram (ECG). This information helps the physician to find places in hearts that may need to be treated. The catheter also helps the physician to visualize important locations in a person’s heart.The study is prospective, meaning that it follows over time a group of individuals who have a similar medical condition, and it will be conducted in approximately 6 hospitals in Europe and South-America(it is multi-center).
There is only one group of treatment and it will be utilizing the investigational diagnostic OCTARAY™ catheter.The study will enroll 30 subjects, with a distribution of approximately 10 per sub-group (type of arrhythmia): Ischemic ventricular tachycardia, Persistent atrial fibrillation, Atrial tachycardia.
Subjects will undergo a standard of care ablation procedure (supported by the OCTARAY™ catheter) and will have a safety follow-up visit/call at 7 days post-procedure.
REC name
West of Scotland REC 4
REC reference
18/WS/0165
Date of REC Opinion
11 Oct 2018
REC opinion
Further Information Favourable Opinion