Clinical Trial

OPTION-EMEA Clinical Trial

Study acronym: OPTION-EMEA
Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 2 changes
critical Recruitment opened 2026-06-26
minor Completion pushed: 2028-12 -> 2029-12 2026-06-26
Trial Details
NCT Number NCT07349121
Lead Sponsor Boston Scientific Corporation
Conditions Atrial Fibrillation (AF), Stroke Prevention in Patients With Atrial Fibrillation, Left Atrial Appendage Closure, Pulsed Field Ablation, Atrial Fibrillation Ablation Procedure, Concomitant Procedures
Enrollment 500 participants
Start Date 2026-06-18
Primary Completion 2028-12 (estimated)
Study Completion 2029-12 (estimated)
Updated on ClinicalTrials.gov 2026-08-05