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Clinical Trials in China / NCT06686485
Active, not recruiting Observational

cOncomitant Left Atrial aPpendage Closure and Pulsed Field ablaTION-Asia

NCT06686485 · tracked via the Priya Life Science China tracker
Sponsor
Boston Scientific Corporation
Phase
Observational
Started
2025-03-18
Last updated
2026-09-02

Condition(s) studied

Concomitant ProceduresAtrial FibrillationPFALAAC

Investigational drug(s) / intervention(s)

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)

Trial sites (37)

FacilityCityRegionStatus
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

More Boston Scientific Corporation trials in China

Other trials for the same condition

Official registry record

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