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
- Diseases
- Atrial fibrillation
- 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
Sites (37)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Xuanwu Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Beijing Anzhen Hospital of the Capital University of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The First Affiliated Hospital of Chengdu Medical College Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Huaxi Hospital of Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| The Third Affiliated Hospital of Guangzhou Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Guangdong Nanfang Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The Affiliated Hospital of Guizhou Medical University Coordinator of this site? Confirm its status | Guiyang | China | Unknown status |
| Sir Run Run Shaw Hospital of Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Qilu Hospital of Shandong University Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| First People's Hospital of Yunnan Province Coordinator of this site? Confirm its status | Kunming | China | Unknown status |
| Affiliated Hospital of Nantong University Coordinator of this site? Confirm its status | Nantong | China | Unknown status |
| The First Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
| Shanxi Cardiovascular Hospital Coordinator of this site? Confirm its status | Taiyuan | China | Unknown status |
| Zhuhai People's Hospital Coordinator of this site? Confirm its status | Zhuhai | China | Unknown status |
| Zigong First People's Hospital Coordinator of this site? Confirm its status | Zigong | China | Unknown status |
| Princess Margaret Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
| Queen Mary Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
| Prince of Wales Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
| Queen Elizabeth Hospital Coordinator of this site? Confirm its status | Kowloon | Hong Kong SAR China | Unknown status |
| Sakakibara Heart Institute, Sakakibara Heart Foundation Coordinator of this site? Confirm its status | Fuchu-shi | Japan | Unknown status |
| Kokura Memorial Hospital Coordinator of this site? Confirm its status | Fukuoka-ken | Japan | Unknown status |
| Shonan Kamakura General Hospital Coordinator of this site? Confirm its status | Kamakura-shi | Japan | Unknown status |
| Yokosuka Kyosai Hospital Coordinator of this site? Confirm its status | Kanagawa | Japan | Unknown status |
| Kawasaki Saiwai Hospital Coordinator of this site? Confirm its status | Kawasaki | Japan | Unknown status |
| Kurashiki Central Hospital Coordinator of this site? Confirm its status | Kurashiki-shi | Japan | Unknown status |
| Toho University Ohashi Medical Center Coordinator of this site? Confirm its status | Meguro-ku | Japan | Unknown status |
| Osaka Keisatsu Hospital Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Saitama Red Cross Hospital Coordinator of this site? Confirm its status | Saitama | Japan | Unknown status |
| Sendai Kousei Hospital Coordinator of this site? Confirm its status | Sendai | Japan | Unknown status |
| Yokohama City Minato Red Cross Hospital Coordinator of this site? Confirm its status | Yokohama | Japan | Unknown status |
| Institute Jantung Negara Coordinator of this site? Confirm its status | Kuala Lumpur | Malaysia | Unknown status |
| Pusat Jantung Sarawak Coordinator of this site? Confirm its status | Kuching | Malaysia | Unknown status |
| Asian Heart and Vascular Centre Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| China Medical University Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| Taichung Veterans General Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| Taipei Veterans General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.