OPALISE (Sub-Protocol to the FARAVERSE Registry)
Research type
Research Study
Full title
A Registry on the FARAVIEW Technology of the OPAL HDx Mapping System when used with the FARAWAVE NAV Ablation Catheter in the treatment of Atrial Fibrillation
IRAS ID
361184
Contact name
Christopher Aldo Rinaldi
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 FARAVERSE Registry will collect data under several different sub-protocols. One of the sub-protocols is the OPALISE study. Your data will be collected under the OPALISE Study. The purpose of the OPALISE Sub-Protocol is to continuously assess the safety and effectiveness of the FARAPULSE Pulsed Field Ablation system when used with the Boston Scientific Mapping System, as well as to analyse clinical steps that are taken during the procedure. All devices used during the ablation procedure will be commercially available and used per the normal practice at your hospital. The Boston Scientific Mapping System includes a specific feature, called the FARAVIEW User Interface, which allows visualization of the heart during the ablation procedure.
Data will be collected for a period of 12 months after the ablation procedure has taken place. You will be contacted at 3 months, 6 months and 12 months after the index procedure, per the hospital’s Standard of Care. Data will be collected before, during and after your ablation procedure. Data collection includes information about your medical history, ablation procedure, your physical and health status, your medication status, and your heart condition.
In addition to the sub-protocol specific purposes, the data that is collected from patients who are participating in other sub-protocols of the FARAVERSE registry, may be combined and analysed together. The intent of collecting of data of all patients who are being treated with the FARAPULSE System, under the FARAVERSE Registry, is to gather real world data evidence which can be used to benefit and support interest of other patients, clinicians and hospitals.
REC name
North East - York Research Ethics Committee
REC reference
25/NE/0194
Date of REC Opinion
5 Dec 2025
REC opinion
Further Information Favourable Opinion