FARAWAY (Sub-Protocol to the FARAVERSE Registry)
Research type
Research Study
Full title
A FARAPULSE Pulsed Field Ablation ProspectiVE RegiStry in REal Life Utilization
IRAS ID
354408
Contact name
Richard Balasubramaniam
Contact email
Sponsor organisation
Boston Scientific International S.A.
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
The FARAWAY Study is a Sub-Protocol related to the FARAVERSE Registry.
The study is designed to determine the best practices in the patient pathway, and to analyze pre-procedural, procedural and follow-up workflow data related with ablation of atrial fibrillation where the FARAPULSE™ Pulsed Field Ablation System is used in a commercial and standard of care setting. Workflow-related variables, inclusive of pre-procedural imaging, methods of transseptal access, anesthesia/sedation technique, intracardiac mapping, ablation strategy and general procedure management, will be used to identify predominant workflow schemes that will be associated with patient demographics, procedure-related complications (safety parameters), and one-year effectiveness parameters. Additionally, the FARAWAY study is designed to assess the impact of adjunctive use of ICE or 3D mapping on safety and efficacy of catheter ablation for the treatment of atrial fibrillation using the FARAPULSE PFA system.
The study data can be used for procedural workflow optimization when using Pulsed Field Ablation for the ablation treatment of Atrial Fibrillation based on patient demographics, cardiac anatomy and arrhythmia characteristics.REC name
North East - York Research Ethics Committee
REC reference
25/NE/0104
Date of REC Opinion
28 Jul 2025
REC opinion
Further Information Favourable Opinion