clinical trial · NCT07349121
OPTION-EMEA Clinical Trial
Atrial Fibrillation (AF)Stroke Prevention in Patients With Atrial FibrillationLeft Atrial Appendage ClosurePulsed Field AblationAtrial Fibrillation Ablation ProcedureConcomitant ProceduresConcomitant pulsed field ablation (PFA) and left atrial appendage closure (LAAC) during one interventional caseConcomitant Pulsed Field Ablation and Left Atrial Appendage Closure
brief summary
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.
started
Apr 1, 2026
primary completion
Dec 1, 2028
completion
Dec 1, 2028
last updated
Apr 14, 2026
official title
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation - Europe, Middle East and Africa [OPTION-EMEA]
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol