The OPTION-EMEA post-market study is intended to gather real world clinical data for patients undergoing AF ablation with the FARAPULSE™ Pulsed Field Ablation (PFA) System and subsequent left atrial appendage closure (LAAC) with a WATCHMAN FLX™ Pro or WATCHMAN FLX device during one interventional case.
The study will include patients that are clinically indicated for atrial fibrillation (AF) ablation using the FARAPULSE PFA System and for left atrial appendage closure (LAAC) treatment using a WATCHMAN FLX Pro or WATCHMAN FLX device as part of the patient's standard of care determined by their doctor's medical judgement.
Clinically indicated for treatment with both the FARAPULSE™ PFA system and with WATCHMAN FLX™ Pro or WATCHMAN FLX™ for LAAC, per physician medical judgement and as per hospitals' standard of care.
Subjects who are willing and able to provide informed consent.
Subjects who are willing and able to participate in all testing associated with this clinical study at an approved investigational center.
Subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law.
Subjects who underwent prior AF ablation procedure.
Subjects with atrial fibrillation that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes.
Already surgically closed or otherwise excluded LAA.
The LAA anatomy does not accommodate a Closure Device.
Single group
Concomitant pulsed field ablation (PFA) and left atrial appendage closure (LAAC) during one interventional case
Deviceleft atrial appendage closure
Concomitant Pulsed Field Ablation and Left Atrial Appendage Closure
Procedure/SurgeryFARAPULSE PFA and WATCHMAN FLX Pro or WATCHMAN FLX in one interventional case.
Primary Safety Endpoint (PSE): Device or Procedure Related Serious Adverse Events
The PSE is the proportion of subjects who experience one or more device- or procedure-related composite serious adverse events (CSAEs) assessed at 30 days following the index procedure.
Primary Efficacy Endpoint (PEE): Acute Treatment Success
The PEE is the proportion of subjects with Acute Treatment Success assessed among those receiving ≥ 1 PFA application and who have WATCHMAN device deployment attempted or successfully implanted.
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