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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
500
left atrial appendage closure
FARAPULSE PFA and WATCHMAN FLX Pro or WATCHMAN FLX in one interventional case.
Clinique Pasteur - Toulouse
Toulouse, France
University Hospital of Salamanca
Salamanca, Spain
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.
Time frame: 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.
Time frame: Through 30 days
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