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RECRUITING
NCT06686485

cOncomitant Left Atrial aPpendage Closure and Pulsed Field ablaTION-Asia

Sponsor: Boston Scientific Corporation

View on ClinicalTrials.gov

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

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.

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