cOncomitant Left Atrial aPpendage Closure and Pulsed Field ablaTION-Asia
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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.
Eligibility
Primary outcome measure(s)
- Periprocedural or procedure-related Composite Serious Adverse Events will be assessed — 30 days post index procedure
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. - Acute Treatment Success will be assessed — between index procedure and 30 days post index procedure
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.
Trial sites (37)
| Facility | City | Region | Status |
|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | |
| 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 | |
| The First Affiliated Hospital of Chengdu Medical College | Chengdu | China | |
| Guangdong Nanfang Hospital | Guangzhou | China | |
| The Third Affiliated Hospital of Guangzhou Medical University | 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 | |
| Affiliated Hospital of Nantong University | Nantong | China | |
| Shanxi Cardiovascular Hospital | Taiyuan | China | |
| Zhuhai People's Hospital | Zhuhai | 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 | |
| Sendai Kousei Hospital | Sendai | Miyagi | |
| Kurashiki Central Hospital | Kurashiki-shi | Okayama Kurashiki-shi | |
| Saitama Red Cross Hospital | Saitama | Saitama | |
| Sakakibara Heart Institute, Sakakibara Heart Foundation | Fuchu-shi | Tokyo | |
| Kokura Memorial Hospital | Fukuoka-ken | Japan | |
| Yokosuka Kyosai Hospital | Kanagawa | Japan | |
| Kawasaki Saiwai Hospital | Kawasaki | Japan | |
| Toho University Ohashi Medical Center | Meguro-ku | Japan | |
| Osaka Keisatsu Hospital | Osaka | Japan | |
| Yokohama city minato Red Cross Hospital | Yokohama | Japan | |
| Institute Jantung Negara | Kuala Lumpur | Malaysia | |
| Pusat Jantung Sarawak | Kuching | Malaysia | |
| Asian Heart and Vascular Centre | Singapore | Singapore | |
| China Medical University Hospital | Taichung | Taiwan | |
| Taichung Veterans General Hospital | Taichung | Taiwan | |
| National Taiwan University Hospital | Taipei | Taiwan | |
| Taipei Veterans General Hospital | Taipei | Taiwan |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06686485 on ClinicalTrials.gov ↗ ← All trials in China