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NCT06686485Active, not recruiting

cOncomitant Left Atrial aPpendage Closure and Pulsed Field ablaTION-Asia

Source: ClinicalTrials.gov · Last updated 23 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
433 (estimated)
First submitted
8 Nov 2024
Start date
18 Mar 2025
Primary completion date
31 Oct 2026
Lead sponsor
Boston Scientific Corporation
NCT number
NCT06686485

What you commit to

  • Study type: Observational
  • Planned participants: 433
  • From 18 Mar 2025 to the primary completion date, 31 Oct 2026
  • 37 sites in 6 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Subjects who underwent prior AF ablation procedure.
  • 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.

Other illness

  • Subjects with atrial fibrillation that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes.
  • Subjects with a current interatrial baffle or patch, history of atrial septal repair or has an ASD/PFO device.
  • 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 active conditions (e.g. infection, bleeding disorder, unstable angina) are present.
  • Subjects with any contraindications to short term use of anticoagulation therapy, or aspirin for conditions different from atrial fibrillation.

Other

  • 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 presence of a mechanical valve prosthesis in any position.
  • Subjects with a known inability to obtain vascular access.
  • Subjects who are pregnant or planning to be pregnant.
  • Subjects with a life expectancy of ≤ 1 year per investigator's opinion.
  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (37)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Xuanwu Hospital, Capital Medical University
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BeijingChinaUnknown status
Beijing Anzhen Hospital of the Capital University of Medical Sciences
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BeijingChinaUnknown status
The First Affiliated Hospital of Chengdu Medical College
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ChengduChinaUnknown status
Huaxi Hospital of Sichuan University
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ChengduChinaUnknown status
The Third Affiliated Hospital of Guangzhou Medical University
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GuangzhouChinaUnknown status
Guangdong Nanfang Hospital
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GuangzhouChinaUnknown status
The Affiliated Hospital of Guizhou Medical University
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GuiyangChinaUnknown status
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
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HangzhouChinaUnknown status
Qilu Hospital of Shandong University
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JinanChinaUnknown status
First People's Hospital of Yunnan Province
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KunmingChinaUnknown status
Affiliated Hospital of Nantong University
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NantongChinaUnknown status
The First Affiliated Hospital of Soochow University
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SuzhouChinaUnknown status
Shanxi Cardiovascular Hospital
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TaiyuanChinaUnknown status
Zhuhai People's Hospital
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ZhuhaiChinaUnknown status
Zigong First People's Hospital
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ZigongChinaUnknown status
Princess Margaret Hospital
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Hong KongHong Kong SAR ChinaUnknown status
Queen Mary Hospital
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Hong KongHong Kong SAR ChinaUnknown status
Prince of Wales Hospital
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Hong KongHong Kong SAR ChinaUnknown status
Queen Elizabeth Hospital
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KowloonHong Kong SAR ChinaUnknown status
Sakakibara Heart Institute, Sakakibara Heart Foundation
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Fuchu-shiJapanUnknown status
Kokura Memorial Hospital
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Fukuoka-kenJapanUnknown status
Shonan Kamakura General Hospital
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Kamakura-shiJapanUnknown status
Yokosuka Kyosai Hospital
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KanagawaJapanUnknown status
Kawasaki Saiwai Hospital
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KawasakiJapanUnknown status
Kurashiki Central Hospital
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Kurashiki-shiJapanUnknown status
Toho University Ohashi Medical Center
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Meguro-kuJapanUnknown status
Osaka Keisatsu Hospital
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OsakaJapanUnknown status
Saitama Red Cross Hospital
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SaitamaJapanUnknown status
Sendai Kousei Hospital
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SendaiJapanUnknown status
Yokohama City Minato Red Cross Hospital
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YokohamaJapanUnknown status
Institute Jantung Negara
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Kuala LumpurMalaysiaUnknown status
Pusat Jantung Sarawak
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KuchingMalaysiaUnknown status
Asian Heart and Vascular Centre
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SingaporeSingaporeUnknown status
China Medical University Hospital
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TaichungTaiwanUnknown status
Taichung Veterans General Hospital
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TaichungTaiwanUnknown status
Taipei Veterans General Hospital
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TaipeiTaiwanUnknown status
National Taiwan University Hospital
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TaipeiTaiwanUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.