NCT06686485

cOncomitant Left Atrial aPpendage Closure and Pulsed Field ablaTION-Asia

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 433 (estimated)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The OPTION-A Study is an observational, prospective, single-arm, multi-center non-mandated post-market study. 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. The objective(s) of the OPTION-A Study is to evaluate safety and effectiveness of catheter ablation with the FARAPULSE™ Pulsed Field Ablation (PFA) System and subsequent implant of Left Atrial Appendage closure (LAAC) with the WATCHMAN™ LAA Closure device in a concomitant procedure.

Conditions

• Concomitant Procedures
• Atrial Fibrillation
• PFA
• LAAC

Interventions

Type	Name	Description
DEVICE	FARAPULSE™ PFA system and WATCHMAN LAAC Delivery Systems	The FARAPULSE™ PFA System consists of the FARAWAVE™ Pulsed Field Ablation Catheter, the FARASTAR™ Pulsed Field Ablation Generator, and the FARADRIVE™ Steerable Sheath. The WATCHMAN LAA Closure Technology consists of the WATCHMAN Access System (which consists of the Access Sheath and Dilator and the WATCHMAN Delivery System (which consists of the delivery catheter and the pre-loaded closure device). The WATCHMAN Access System and WATCHMAN Delivery System permit device placement in the LAA via femoral venous access and crossing the inter-atrial septum into the left atrium.

Timeline

• Start date: 2025-03-18
• Primary completion: 2026-10-31
• Completion: 2029-10-31
• First posted: 2024-11-13
• Last updated: 2026-03-27

Locations

30 sites across 6 countries: China, Hong Kong, Japan, Malaysia, Singapore, Taiwan