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Research type
Research Study
Full title
ELectrical COupling Information From The RhythmiaTM HDx Mapping System And DireCtSenseTM Technology In The Treatment Of Paroxysmal AtriaL FibrIllation- A Non-RandomiZed, ProspEctive Study
IRAS ID
239560
Contact name
Moloy Das
Contact email
Sponsor organisation
Boston Scientific-Guidant Europe NV
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 10 months, 17 days
Research summary
This study is designed to collect information about the use of the Rhythmia electrophysiology system when used with a certain type of mapping catheter. A mapping catheter is the electrical “cable” which is inserted into a patient’s heart to record electrical signals. The catheter under observation is the IntellaMap Orion with DirectSense technology and is manufactured by Boston Scientific.
Patients with paroxysmal AF (an occasional irregular heart rhythm in the upper chambers of the heart) can be referred for ablation treatment. It is this group of patients that will be included in this study. Only patients with newly diagnosed paroxysmal AF and that are receiving this treatment for the first time will be recruited.
Data from the Rhythmia mapping system will be collected during the procedure. This data will be used to create guidance for a feature of the system (called local impedance) and to further develop an additional feature called lesion indexing.REC name
North West - Haydock Research Ethics Committee
REC reference
18/NW/0105
Date of REC Opinion
13 Mar 2018
REC opinion
Further Information Favourable Opinion