LOCALIZE CF
Research type
Research Study
Full title
Electrical Coupling Information From The RHYTHMIA™ HDx Mapping System and DIRECTSENSE™ Technology In The Treatment of Paroxysmal Atrial Fibrillation: A Non-Randomized Prospective Study with Contact Force
IRAS ID
292474
Contact name
Moloy Das
Contact email
Sponsor organisation
Boston Scientific International SA
Duration of Study in the UK
1 years, 9 months, 1 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 ablation catheter. An ablation catheter is the electrical “cable” which is inserted into a patient’s heart to record electrical signals and deliver energy. The delivered energy intentionally scars a small area of the heart muscle. The areas targeted are known to be trigger points for abnormal heart rhythms.
The catheter under observation is the INTELLANAV STABLEPOINT™ 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) which may allow operators to increase procedural success.
REC name
West of Scotland REC 4
REC reference
21/WS/0015
Date of REC Opinion
25 Mar 2021
REC opinion
Further Information Unfavourable Opinion