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cOncomitant Left Atrial aPpendage Closure and Pulsed Field ablaTION-Asia
Sponsor: Boston Scientific Corporation
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
433
Start Date
2025-03-18
Completion Date
2029-10-31
Last Updated
2026-03-27
Healthy Volunteers
No
Interventions
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.
Locations (30)
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Beijing Anzhen Hospital of the Capital University of Medical Sciences
Beijing, China
Xuanwu Hospital Capital Medical University
Beijing, China
Huaxi Hospital of Sichuan University
Chengdu, China
Guangdong Nanfang Hospital
Guangzhou, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, China
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Hangzhou, China
QiLu Hospital of ShanDong University
Jinan, China
First People's Hospital of Yunnan Province
Kunming, China
Shanxi Cardiovascular Hospital
Taiyuan, China
Zigong First People's Hospital
Zigong, China
Prince of Wales Hospital
Hong Kong, Hong Kong
Princess Margaret Hospital
Hong Kong, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Queen Elizabeth Hospital
Kowloon, Hong Kong
Shonan Kamakura General Hospital
Kamakura-shi, Kanagawa, Japan
Sendai Kousei Hospital
Sendai, Miyagi, Japan
Kurashiki Central Hospital
Kurashiki-shi, Okayama Kurashiki-shi, Japan
Saitama Red Cross Hospital
Saitama, Saitama, Japan
Sakakibara Heart Institute, Sakakibara Heart Foundation
Fuchu-shi, Tokyo, Japan
Kokura Memorial Hospital
Fukuoka-ken, Japan
Yokosuka Kyosai Hospital
Kanagawa, Japan
Toho University Ohashi Medical Center
Meguro-ku, Japan
Osaka Keisatsu Hospital
Osaka, Japan
Institute Jantung Negara
Kuala Lumpur, Malaysia
Pusat Jantung Sarawak
Kuching, Malaysia
Asian Heart and Vascular Centre
Singapore, Singapore
Taichung Veterans General Hospital
Taichung, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan