A RWS of the FARAPULSE in A Chinese Population With PAF

Status Active, not recruiting

Clinical Trial Summary

The real world study is a retrospective and/or prospective, single-center, single-arm observational study to observe the safety and effectiveness of the FARAPULSE Pulsed Field Ablation System for treatment of recurrent, symptomatic Paroxysmal Atrial Fibrillation (PAF) in a Chinese population.

Clinical Trial Description

The primary effectiveness endpoint is the acute procedural success, defined as the proportion of subjects that achieve electrical isolation of all PVs using FARAPULSE Pulsed Field Ablation system only. The primary safety endpoint is defined as the occurrence of the acute serious procedure-related and /or device-related adverse events at 7 days post index procedure. Primary endpoints analysis is planned to be conducted after all enrolled subjects have completed data collection at 1-month follow-up visit. All the subjects underwent study device treatment will be followed up to 12 months after the procedure, and the secondary and other endpoints will be analyzed then. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05493852
Study type	Observational
Source	Boston Scientific Corporation
Contact
Status	Active, not recruiting
Phase
Start date	February 24, 2023
Completion date	December 31, 2024

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