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cOncomitant Left Atrial aPpendage Closure and Pulsed Field ablaTION-Asia

Study acronym: OPTION-A
StatusActive, Not Recruiting
PhaseNot specified
Started2025-03-18
View on ClinicalTrials.gov ↗

Amendment history

2026-08-31
Study Status, Contacts/Locations v20
Enrollment closed, study ongoing
Study sitesdetails revised at 37 of 37 sites
2026-07-22
Study Status v19
Re-verified, no change to tracked fields
2026-06-22
Study Status, Contacts/Locations v18
Study sitesdetails revised at 1 of 37 sites
2026-05-12
Study Status, Contacts/Locations v17
Trial sites expanded: 34 → 37 locations
2026-05-04
Study Status, Eligibility, Contacts/Locations v16
Trial sites expanded: 30 → 34 locations
Eligibility criteria+102 characters
[...] onal anomalies of the heart or great vessels) are present*. Subjects with any active conditions (e.g. infection, bleeding disorder, unstable angina) are present. Subjects with any contraindications to short term use of ant [...]
Show 15 earlier versions
2026-03-24
Study Status, Contacts/Locations v15
Study sites29→30
2026-02-27
Study Status, Contacts/Locations v14
Study sites27→29
2026-01-22
Study Status, Contacts/Locations v13
Study sites21→27
2025-12-16
Study Status, Contacts/Locations v12
Study sites20→21
2025-11-29
Study Status, Contacts/Locations v11
Study sites13→20
2025-11-14
Study Status, Oversight v10
Re-verified, no change to tracked fields
2025-09-16
Study Status, Contacts/Locations v9
Study sites11→13
2025-08-28
Study Status, Contacts/Locations v8
Study sites9→11
2025-07-28
Study Status, Contacts/Locations v7
Study sites7→9
2025-06-30
Study Status, Contacts/Locations v6
Study sites2→7
2025-05-30
Study Status, Contacts/Locations v5
Study sites1→2
2025-04-23
Study Status v4
Re-verified, no change to tracked fields
2025-03-28
Not Yet Recruiting→Recruiting Study Identification, Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-03-31→confirmed 2025-03-18
Study sites0→1
Study titlerevised
COncomitantcOncomitant Left Atrial APpendageaPpendage Closure and Pulsed Field AblaTIONablaTION-Asia
2025-02-24
2 amendments v1-v2
2 re-verifications since 2025-01-14, no change to tracked fields
2024-11-11
Original filing
Subjects enrolled in the OPTION-A study will be clinically indicated for atrial fibrillation (AF) ablation procedure with the FARAPULSE™ PFA system and treatment with WATCHMAN LAAC Device, per physician's medical judgement and according to hospitals' standard of care during the same procedure.
Trial Details
NCT Number NCT06686485
Lead Sponsor Boston Scientific Corporation
Conditions Concomitant Procedures, Atrial Fibrillation, PFA, LAAC
Enrollment 433 participants
Start Date 2025-03-18
Primary Completion 2026-10-31 (estimated)
Study Completion 2029-10-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-24