NEWTON AF
Research type
Research Study
Full title
Clinical Evaluation of the StablePoint Catheter and Force-Sensing System for Paroxysmal Atrial Fibrillation.
IRAS ID
291937
Contact name
Dhiraj Gupta
Contact email
Sponsor organisation
Boston Scientific Corporation
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 1 months, 31 days
Research summary
This study is designed to collect data about the safety and effectiveness of a certain type of ablation catheter designed to be used with the Rhythmia HDx electrophysiology system. An ablation catheter is the electrical 'cable' which is inserted into a patient's heart to deliver energy to destroy the abnormal heart tissue that cause abnormal heart rhythms. The catheter under observation is the Boston Scientific IntellaNav Stablepoint Catheter and Force Sensing System with DIRECTSENSE technology. The IntellaNav StablePoint Ablation Catheter is a single-use, steerable,open-irrigated ablation catheter designed to deliver Radiofrequency (RF) energy to the catheter tip for cardiac ablation.
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.
Data will be collected before, during and after the participant’s ablation procedure. Participants will also need to return to the hospital for follow-up visits at 1, 3, 6 and 12 months after the ablation procedure.
All subjects signing the consent, undergoing the index procedure and treated with the study devices will be followed up for one year.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
21/NW/0140
Date of REC Opinion
20 May 2021
REC opinion
Favourable Opinion