To obtain real world data on the use of, and provide continued evidence on safety and effectiveness of the FARAPULSE™ Pulsed Field Ablation (PFA) system when used per hospitals' standard of care in Chinese population.
The study is an observational, prospective, non-randomized, single-arm, multi-center post-market study. All subjects signing the informed consent form, will be included in the study. All subjects treated with the FARAPULSE™ PFA system will be followed for three years. Subjects will undergo the index procedure per hospitals' standard of care after enrollment, and followed at pre-discharge, 3 Month, 6 Month (Phone call only), 12 Month (in-clinic visit mandatory), 24 Month (2 Year) and 36 Month (3 Year).
Study Type
OBSERVATIONAL
Enrollment
500
no intervention design in the study
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, China/Beijing, China
RECRUITINGFailure-free rate
Failure-free rate at 12 Month post index procedure.
Time frame: 12 Months
Device-or procedure-related SAEs:
Composite of the following device- or procedure-related SAEs:
Time frame: 7 days and 12 months
Procedure- and device related adverse events
All FARAPULSE™ PFA procedure- and device related adverse events at 12 Month, 2 Year and 3 Year follow-up.
Time frame: 12 Months and 2 years and 3 years
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