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.
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.
Study Type
OBSERVATIONAL
Enrollment
433
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.
Periprocedural or procedure-related Composite Serious Adverse Events will be assessed
The primary safety endpoint (PSE) is the proportion of subjects with one or more of the periprocedural device or procedure-related Composite Serious Adverse Events (CSAEs) assessed at 30 days following the Index Procedure.
Time frame: 30 days post index procedure
Acute Treatment Success will be assessed
The primary effectiveness endpoint (PEE) is the proportion of subjects with Acute Treatment Success assessed among those receiving ≥1 PFA application and who have a WATCHMAN attempted or implanted.
Time frame: between index procedure and 30 days post index procedure
Device or procedure-related Composite Serious Adverse Events (CSAEs) assessed
Device or procedure-related Composite Serious Adverse Events (CSAEs) assessed at 360 days following the Index Procedure
Time frame: 1 year post index procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Beijing Anzhen Hospital of the Capital University of Medical Sciences
Beijing, China
RECRUITINGHuaxi Hospital of Sichuan University
Chengdu, China
RECRUITINGThe Affiliated Hospital of Guizhou Medical University
Guiyang, China
RECRUITINGSir Run Run Shaw Hospital of Zhejiang University School of Medicine
Hangzhou, China
RECRUITINGQiLu Hospital of ShanDong University
Jinan, China
RECRUITINGShanxi Cardiovascular Hospital
Taiyuan, China
RECRUITINGZigong First People's Hospital
Zigong, China
RECRUITINGPrince of Wales Hospital
Hong Kong, Hong Kong
RECRUITINGPrincess Margaret Hospital
Hong Kong, Hong Kong
RECRUITING...and 17 more locations