NCT06686485 cOncomitant Left Atrial aPpendage Closure and Pulsed Field ablaTION-Asia
| NCT ID | NCT06686485 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Boston Scientific Corporation |
| Condition | Concomitant Procedures |
| Study Type | OBSERVATIONAL |
| Enrollment | 433 participants |
| Start Date | 2025-03-18 |
| Primary Completion | 2026-10-31 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Clinically indicated for treatment with both the FARAPULSE™ PFA system and with WATCHMAN for LAAC, per physician medical judgement and as per hospitals' standard of care. 2. Subjects who are willing and able to provide informed consent. 3. Subjects who are willing and able to participate in all testing associated with this clinical study at an approved clinical investigational center. 4. Subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law. Exclusion Criteria: 1. Subjects who underwent prior AF ablation procedure. 2. Subjects with atrial fibrillation that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes. 3. Already surgically closed or otherwise excluded LAA. 4. The LAA anatomy does not accommodate a Closure Device. 5. Known or suspected atrial myxoma. 6. Presence of intracardiac thrombus. 7. Subjects with a current interatrial baffle o