cOncomitant Left Atrial aPpendage Closure and Pulsed Field ablaTION-Asia
NCT ID: NCT06686485
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
433 participants
OBSERVATIONAL
2025-03-18
2029-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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 contraindications to short term use of anticoagulation therapy, or aspirin for conditions different from atrial fibrillation.
15. Subjects who are pregnant or planning to be pregnant.
16. Subjects with a life expectancy of ≤ 1 year per investigator's opinion.
17. 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.
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Locations
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The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Beijing Anzhen Hospital of the Capital University of Medical Sciences
Beijing, , China
Huaxi Hospital of Sichuan University
Chengdu, , China
The Affiliated Hospital of Guizhou Medical University
Guiyang, , China
QiLu Hospital of ShanDong University
Jinan, , 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
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
Yokosuka Kyosai Hospital
Kanagawa, , Japan
Osaka Keisatsu Hospital
Osaka, , Japan
Institute Jantung Negara
Kuala Lumpur, , 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
Countries
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Central Contacts
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Facility Contacts
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Surinder Dr.
Role: primary
Other Identifiers
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PF316
Identifier Type: -
Identifier Source: org_study_id