cOncomitant Left Atrial aPpendage Closure and Pulsed Field ablaTION-Asia
OPTION-A
1 other identifier
observational
433
6 countries
30
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2025
Longer than P75 for all trials
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 8, 2024
CompletedFirst Posted
Study publicly available on registry
November 13, 2024
CompletedStudy Start
First participant enrolled
March 18, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2029
March 27, 2026
March 1, 2026
1.6 years
November 8, 2024
March 24, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (1)
Device or procedure-related Composite Serious Adverse Events (CSAEs) assessed
1 year post index procedure
Study Arms (1)
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.
Interventions
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
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.
You may qualify if:
- 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.
- Subjects who are willing and able to provide informed consent.
- Subjects who are willing and able to participate in all testing associated with this clinical study at an approved clinical investigational center.
- Subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law.
You may not qualify if:
- Subjects who underwent prior AF ablation procedure.
- Subjects with atrial fibrillation that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes.
- Already surgically closed or otherwise excluded LAA.
- The LAA anatomy does not accommodate a Closure Device.
- Known or suspected atrial myxoma.
- Presence of intracardiac thrombus.
- Subjects with a current interatrial baffle or patch, history of atrial septal repair or has an ASD/PFO device.
- Subjects with a presence of a mechanical valve prosthesis in any position.
- Subjects with a myocardial infarction within 30 days prior to enrollment.
- Subjects had a prior stroke (of any cause, whether ischemic or hemorrhagic) or transient ischemic attack (TIA) within the 90 days prior to enrollment.
- Any planned electrical cardioversion within 30 days following LAAC device implant.
- Subjects with a known inability to obtain vascular access.
- 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\*.
- Subjects with any contraindications to short term use of anticoagulation therapy, or aspirin for conditions different from atrial fibrillation.
- Subjects who are pregnant or planning to be pregnant.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
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
Guangdong Nanfang Hospital
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
Shanxi Cardiovascular Hospital
Taiyuan, 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, 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
Kokura Memorial Hospital
Fukuoka-ken, Japan
Yokosuka Kyosai Hospital
Kanagawa, Japan
Toho University Ohashi Medical Center
Meguro-ku, Japan
Osaka Keisatsu Hospital
Osaka, Japan
Institute Jantung Negara
Kuala Lumpur, Malaysia
Pusat Jantung Sarawak
Kuching, 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 8, 2024
First Posted
November 13, 2024
Study Start
March 18, 2025
Primary Completion (Estimated)
October 31, 2026
Study Completion (Estimated)
October 31, 2029
Last Updated
March 27, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share