Actively Recruiting
cOncomitant Left Atrial aPpendage Closure and Pulsed Field ablaTION-Asia
Led by Boston Scientific Corporation · Updated on 2026-05-14
433
Participants Needed
37
Research Sites
241 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
cOncomitant Left Atrial aPpendage Closure and Pulsed Field ablaTION-Asia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinically indicated for treatment with both the FARAPULSE PFA system and WATCHMAN for left atrial appendage closure, per physician judgment and hospital standards.
- Willing and able to provide informed consent.
- Willing and able to participate in all study testing at an approved clinical center.
- Age 18 years or older, or legal age to give informed consent according to local laws.
You will not qualify if you...
- Prior atrial fibrillation ablation procedure.
- Atrial fibrillation caused by electrolyte imbalance, thyroid disease, alcohol, or other reversible/non-cardiac causes.
- Left atrial appendage already surgically closed or excluded.
- Left atrial appendage anatomy unsuitable for closure device.
- Known or suspected atrial myxoma.
- Presence of intracardiac thrombus.
- Current interatrial baffle or patch, history of atrial septal repair, or ASD/PFO device.
- Presence of mechanical heart valve prosthesis.
- Myocardial infarction within 30 days before enrollment.
- Stroke or transient ischemic attack within 90 days before enrollment.
- Planned electrical cardioversion within 30 days after device implant.
- Known inability to obtain vascular access.
- Contraindications to percutaneous catheterization or presence of active infections, bleeding disorders, unstable angina, or congenital heart abnormalities.
- Contraindications to short-term anticoagulation or aspirin for conditions other than atrial fibrillation.
- Pregnancy or planning pregnancy.
- Life expectancy of 1 year or less per investigator's opinion.
- Enrollment in another investigational study or registry that interferes with this study, except mandatory or purely observational registries reviewed by the sponsor.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 37 locations
1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Actively Recruiting
2
Beijing Anzhen Hospital of the Capital University of Medical Sciences
Beijing, China
Actively Recruiting
3
Xuanwu Hospital Capital Medical University
Beijing, China
Actively Recruiting
4
Huaxi Hospital of Sichuan University
Chengdu, China
Actively Recruiting
5
The First Affiliated Hospital of Chengdu Medical College
Chengdu, China
Actively Recruiting
6
Guangdong Nanfang Hospital
Guangzhou, China
Actively Recruiting
7
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
Actively Recruiting
8
The Affiliated Hospital of Guizhou Medical University
Guiyang, China
Actively Recruiting
9
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Hangzhou, China
Actively Recruiting
10
QiLu Hospital of ShanDong University
Jinan, China
Actively Recruiting
11
First People's Hospital of Yunnan Province
Kunming, China
Actively Recruiting
12
Affiliated Hospital of Nantong University
Nantong, China
Actively Recruiting
13
Shanxi Cardiovascular Hospital
Taiyuan, China
Actively Recruiting
14
Zhuhai People's Hospital
Zhuhai, China
Actively Recruiting
15
Zigong First People's Hospital
Zigong, China
Actively Recruiting
16
Prince of Wales Hospital
Hong Kong, Hong Kong
Actively Recruiting
17
Princess Margaret Hospital
Hong Kong, Hong Kong
Actively Recruiting
18
Queen Mary Hospital
Hong Kong, Hong Kong
Actively Recruiting
19
Queen Elizabeth Hospital
Kowloon, Hong Kong
Actively Recruiting
20
Shonan Kamakura General Hospital
Kamakura-shi, Kanagawa, Japan
Actively Recruiting
21
Sendai Kousei Hospital
Sendai, Miyagi, Japan
Actively Recruiting
22
Kurashiki Central Hospital
Kurashiki-shi, Okayama Kurashiki-shi, Japan
Actively Recruiting
23
Saitama Red Cross Hospital
Saitama, Saitama, Japan
Actively Recruiting
24
Sakakibara Heart Institute, Sakakibara Heart Foundation
Fuchu-shi, Tokyo, Japan
Actively Recruiting
25
Kokura Memorial Hospital
Fukuoka-ken, Japan
Actively Recruiting
26
Yokosuka Kyosai Hospital
Kanagawa, Japan
Actively Recruiting
27
Kawasaki Saiwai Hospital
Kawasaki, Japan
Actively Recruiting
28
Toho University Ohashi Medical Center
Meguro-ku, Japan
Actively Recruiting
29
Osaka Keisatsu Hospital
Osaka, Japan
Actively Recruiting
30
Yokohama city minato Red Cross Hospital
Yokohama, Japan
Actively Recruiting
31
Institute Jantung Negara
Kuala Lumpur, Malaysia
Actively Recruiting
32
Pusat Jantung Sarawak
Kuching, Malaysia
Actively Recruiting
33
Asian Heart and Vascular Centre
Singapore, Singapore
Actively Recruiting
34
China Medical University Hospital
Taichung, Taiwan
Actively Recruiting
35
Taichung Veterans General Hospital
Taichung, Taiwan
Actively Recruiting
36
National Taiwan University Hospital
Taipei, Taiwan
Actively Recruiting
37
Taipei Veterans General Hospital
Taipei, Taiwan
Actively Recruiting
Research Team
J
Jamie Kwek
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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