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OPTION-EMEA Clinical Trial

Study acronym: OPTION-EMEA
StatusRecruiting
PhaseNot applicable
Started2026-06-18
View on ClinicalTrials.gov ↗

Amendment history

2026-09-09
Study Status, Contacts/Locations v9
Study sitesdetails revised at 1 of 5 sites
2026-08-04
Study Status, Contacts/Locations v8
Study sites3→5
2026-07-31
2 amendments v6-v7
2 re-verifications since 2026-06-26, no change to tracked fields
2026-06-23
Study Status, Contacts/Locations v5
Recruitment opened
Completion pushed: 2028-12 → 2029-12
Start dateestimated 2026-05→confirmed 2026-06-18
Study sites2→3
2026-05-07
Study Status v4
Start date2026-04→2026-05
Show 3 earlier versions
2026-04-11
2 amendments v2-v3
2 re-verifications since 2026-03-11, no change to tracked fields
2026-02-14
Study Status, Contacts/Locations v1
Study sites0→2
2026-01-09
Original filing
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.
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 2026-09-11