Real World Data of FARAPULSE™ Ablation in Chinese Population
Data Collection
Collected from today forward - ProspectiveArrhythmias, Cardiac+3
+ Atrial Fibrillation
+ Cardiovascular Diseases
Other
Utilizing specific methods not covered by standard models in order to address unique research questions.Summary
Study start date: October 23, 2025
Actual date on which the first participant was enrolled.This study focuses on the Chinese population undergoing treatment with the FARAPULSE™ Pulsed Field Ablation System. It's an observational study, meaning it follows and examines the effects of this treatment in real-world settings, without any random assignment or control group. The study is important as it helps understand the long-term safety and effectiveness of the FARAPULSE™ PFA system in a real-world context, potentially improving care for those undergoing this procedure. All participants who sign the informed consent form will be included in the study and followed for three years. After enrollment, participants will undergo the standard procedure with the FARAPULSE™ PFA system. Follow-ups will occur at pre-discharge, 3 months, 6 months (over a phone call), 12 months (mandatory in-clinic visit), 24 months, and 36 months. The study will monitor device- or procedure-related serious adverse events, the failure-free rate at 12 months post-procedure, and all procedure- and device-related adverse events at 12 months, 2 years, and 3 years.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.500 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, ChinaOpen Fuwai Hospital, Chinese Academy of Medical Sciences in Google Maps