FARADISE
Research type
Research Study
Full title
Real world data collection in subjects treated with the FARAPULSE™ Pulsed Field Ablation system
IRAS ID
325083
Contact name
Claire Martin
Contact email
Sponsor organisation
Boston Scientific
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 1 months, 1 days
Research summary
Participants will be asked to take part in the FARADISE Registry on the FARAPULSE™ Pulsed Field Ablation (PFA) system because they have a heart condition that is called atrial fibrillation, where the heart beats irregularly and/or rapidly. Their study doctor will determine whether they will undergo an ablation procedure to try to return their heart rhythm to normal. The procedure used in this clinical study is called pulsed field ablation, which consists in delivering very short electrical pulses to destroy the tissue in their heart that is causing the arrhythmia with minimal or no effect on the structures that are around the heart.
The system that will be used in this registry is the FARAPULSE™ Pulsed Field Ablation (PFA) system, which is approved for commercial use in the UK and Europe for the treatment of atrial fibrillation. This means that the system is not investigational. The purpose of this study is to collect information on how the device is performing when used in a typical hospital environment (i.e. per standard of care use), and to continue to collect information on the safety and effectiveness of the FARAPULSE™ Pulsed Field Ablation System. This information will be collected in a large group of patients and over a longer period of time compared to previous clinical studies where its safety and effectiveness have been confirmed.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
23/EE/0115
Date of REC Opinion
16 Jun 2023
REC opinion
Further Information Favourable Opinion