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Real World Data Collection in Subjects Treated With the FARAPULSE Pulsed Field Ablation System — FARADISE  

Atrial Fibrillation Clinical Trial

Official title:
Real World Data Collection in Subjects Treated With the FARAPULSE Pulsed Field Ablation System

Clinical Trial Summary

The goal of any novel design or therapeutic strategy to treat atrial fibrillation is to restore normal sinus rhythm and to reduce or eliminate the symptoms due to rapid atrial response. Boston Scientific has developed the FARAPULSE™ Pulsed Field Ablation therapy that uses irreversible electroporation to induce cell death. This Registry is intended to obtain purely observational and prospective real world data and to provide continued evidence on the safety and effectiveness when the FARAPULSE™ pulsed field ablation System is used per hospitals' standard of care.

Clinical Trial Description

This Registry is intended to obtain purely observational and prospective real world data about the cardiac ablation procedure in subjects treated with the FARAPULSE™ Pulsed Field Ablation system, to provide continued evidence on the safety and effectiveness of the FARAPULSE™ Pulsed Field Ablation (PFA) System when used per hospitals' standard of care, and to learn the effect of the Pulsed Field Ablation treatment on Quality Of Life in a real-world setting. The study will enroll approximately 1000 to 1500 subjects, in up to 100 sites in Europe (with the potential for expansion of the study to Middle East, Africa and/or Asia Pacific). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05501873
Study type Observational [Patient Registry]
Source Boston Scientific Corporation
Contact
Status Active, not recruiting
Phase
Start date March 24, 2023
Completion date August 15, 2027
View Details
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