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Subjects enrolled in the OPTION-A study will be clinically indicated for atrial fibrillation (AF) ablation procedure with the FARAPULSEâ„¢ 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 FARAPULSEâ„¢ Pulsed Field Ablation (PFA) System and subsequent implant of Left Atrial Appendage closure (LAAC) with the WATCHMANâ„¢ LAA Closure device in a concomitant procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Subjects | A subject is considered enrolled once an approved informed consent form has been signed and dated. Enrolled Subjects will undergo AF ablation procedure with the FARAPULSE PFA System, followed by WATCHMAN implant during the same procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FARAPULSEâ„¢ PFA system and WATCHMAN LAAC Delivery Systems | Device | The FARAPULSEâ„¢ PFA System consists of the FARAWAVEâ„¢ Pulsed Field Ablation Catheter, the FARASTARâ„¢ Pulsed Field Ablation Generator, and the FARADRIVEâ„¢ 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | between index procedure and 30 days post index procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 year post index procedure |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects enrolled in the OPTION-A study will be clinically indicated for an Atrial Fibrillation ablation procedure utilizing the FARAPULSE PFA System as well as implantation of the WATCHMAN device per physician's medical judgement, and according to the hospitals' standard of care during the same procedure. The subjects selected for participation in the study will be from the investigator's general patient population. The investigator or designee has the responsibility for screening all potential subjects and selecting those who meet study eligibility criteria.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jamie Kwek | Contact | +6564188833 | Jamie.Kwek@bsci.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | China | ||
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| Beijing Anzhen Hospital of the Capital University of Medical Sciences |
| Recruiting |
| Beijing |
| China |
| Xuanwu Hospital Capital Medical University | Recruiting | Beijing | China |
| Huaxi Hospital of Sichuan University | Active, not recruiting | Chengdu | China |
| The First Affiliated Hospital of Chengdu Medical College | Recruiting | Chengdu | China |
| Guangdong Nanfang Hospital | Recruiting | Guangzhou | China |
| The Third Affiliated Hospital of Guangzhou Medical University | Recruiting | Guangzhou | China |
| The Affiliated Hospital of Guizhou Medical University | Recruiting | Guiyang | China |
| Sir Run Run Shaw Hospital of Zhejiang University School of Medicine | Recruiting | Hangzhou | China |
| QiLu Hospital of ShanDong University | Recruiting | Jinan | China |
| First People's Hospital of Yunnan Province | Recruiting | Kunming | China |
| Affiliated Hospital of Nantong University | Recruiting | Nantong | China |
| Shanxi Cardiovascular Hospital | Recruiting | Taiyuan | China |
| Zhuhai People's Hospital | Recruiting | Zhuhai | China |
| Zigong First People's Hospital | Recruiting | Zigong | China |
| Prince of Wales Hospital | Recruiting | Hong Kong | Hong Kong |
| Princess Margaret Hospital | Recruiting | Hong Kong | Hong Kong |
| Queen Mary Hospital | Recruiting | Hong Kong | Hong Kong |
| Queen Elizabeth Hospital | Recruiting | Kowloon | Hong Kong |
| Shonan Kamakura General Hospital | Recruiting | Kamakura-shi | Kanagawa | Japan |
| Sendai Kousei Hospital | Recruiting | Sendai | Miyagi | Japan |
| Kurashiki Central Hospital | Recruiting | Kurashiki-shi | Okayama Kurashiki-shi | Japan |
| Saitama Red Cross Hospital | Recruiting | Saitama | Saitama | Japan |
| Sakakibara Heart Institute, Sakakibara Heart Foundation | Recruiting | Fuchu-shi | Tokyo | Japan |
| Kokura Memorial Hospital | Recruiting | Fukuoka-ken | Japan |
| Yokosuka Kyosai Hospital | Recruiting | Kanagawa | Japan |
| Kawasaki Saiwai Hospital | Recruiting | Kawasaki | Japan |
| Toho University Ohashi Medical Center | Recruiting | Meguro-ku | Japan |
| Osaka Keisatsu Hospital | Recruiting | Osaka | Japan |
| Yokohama city minato Red Cross Hospital | Recruiting | Yokohama | Japan |
| Institute Jantung Negara | Recruiting | Kuala Lumpur | Malaysia |
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| Pusat Jantung Sarawak | Recruiting | Kuching | Malaysia |
| Asian Heart and Vascular Centre | Recruiting | Singapore | Singapore |
| China Medical University Hospital | Recruiting | Taichung | Taiwan |
| Taichung Veterans General Hospital | Recruiting | Taichung | Taiwan |
| National Taiwan University Hospital | Recruiting | Taipei | Taiwan |
| Taipei Veterans General Hospital | Recruiting | Taipei | Taiwan |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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