FARAPULSE™ PFA system and WATCHMAN LAAC Delivery Systems
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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Clinically indicated for treatment with both the FARAPULSE™ PFA system and with WATCHMAN for LAAC, per physician medical judgement and as per hospitals' standard of care.
2. Subjects who are willing and able to provide informed consent.
3. Subjects who are willing and able to participate in all testing associated with this clinical study at an approved clinical investigational center.
4. Subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law.
Exclusion Criteria:
1. Subjects who underwent prior AF ablation procedure.
2. Subjects with atrial fibrillation that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes.
3. Already surgically closed or otherwise excluded LAA.
4. The LAA anatomy does not accommodate a Closure Device.
5. Known or suspected atrial myxoma.
6. Presence of intracardiac thrombus.
7. Subjects with a current interatrial baffle or patch, history of atrial septal repair or has an ASD/PFO device.
8. Subjects with a presence of a mechanical valve prosthesis in any position.
9. Subjects with a myocardial infarction within 30 days prior to enrollment.
10. Subjects had a prior stroke (of any cause, whether ischemic or hemorrhagic) or transient ischemic attack (TIA) within the 90 days prior to enrollment.
11. Any planned electrical cardioversion within 30 days following LAAC device implant.
12. Subjects with a known inability to obtain vascular access.
13. Subjects with any contraindication to percutaneous catheterization procedure (e.g., patient size does not accommodate required catheters, ventriculotomy or atriotomy), active conditions (e.g. infection, bleeding disorder, unstable angina) or congenital abnormalities (severe rotational anomalies of the heart or great vessels) are present\*.
14. Subjects with any active conditions (e.g. infection, bleeding disorder, unstable angina) are present.
15. Subjects with any contraindications to short term use of anticoagulation therapy, or aspirin for conditions different from atrial fibrillation.
16. Subjects who are pregnant or planning to be pregnant.
17. Subjects with a life expectancy of ≤ 1 year per investigator's opinion.
18. Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance must be reviewed by the sponsor to determine 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.
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