Concomitant ProceduresOPTION-ANCT06686485
cOncomitant Left Atrial aPpendage Closure and Pulsed Field ablaTION-Asia
An observational study of Concomitant Procedures and Atrial Fibrillation, run by Boston Scientific Corporation at 37 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Concomitant Procedures, Atrial Fibrillation, PFA
- What is being tested?
- FARAPULSE™ PFA system and WATCHMAN LAAC Delivery Systems
- Type of treatment
- Medical device
- How many people
- 433 participants
- Where
- 37 sitesin 6 countries
- Study dates
- 18 Mar 2025to 31 Oct 2029
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 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.
- 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.
Trial locations and contacts
37 sites in 6 countries.
37 sites in 6 countries
China15 sites
Beijing Anzhen Hospital of the Capital University of Medical Sciences
Beijing
Xuanwu Hospital Capital Medical University
Beijing
Huaxi Hospital of Sichuan University
Chengdu
The First Affiliated Hospital of Chengdu Medical College
Chengdu
Guangdong Nanfang Hospital
Guangzhou
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou
The Affiliated Hospital of Guizhou Medical University
Guiyang
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Hangzhou
QiLu Hospital of ShanDong University
Jinan
First People's Hospital of Yunnan Province
Kunming
Affiliated Hospital of Nantong University
Nantong
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu
Shanxi Cardiovascular Hospital
Taiyuan
Zhuhai People's Hospital
Zhuhai
Zigong First People's Hospital
Zigong
Japan11 sites
Sakakibara Heart Institute, Sakakibara Heart Foundation
Fuchu-shi, Tokyo
Kokura Memorial Hospital
Fukuoka-ken
Shonan Kamakura General Hospital
Kamakura-shi, Kanagawa
Yokosuka Kyosai Hospital
Kanagawa
Kawasaki Saiwai Hospital
Kawasaki
Kurashiki Central Hospital
Kurashiki-shi, Okayama Kurashiki-shi
Toho University Ohashi Medical Center
Meguro-ku
Osaka Keisatsu Hospital
Osaka
Saitama Red Cross Hospital
Saitama, Saitama
Sendai Kousei Hospital
Sendai, Miyagi
Yokohama city minato Red Cross Hospital
Yokohama
Hong Kong4 sites
Prince of Wales Hospital
Hong Kong
Princess Margaret Hospital
Hong Kong
Queen Mary Hospital
Hong Kong
Queen Elizabeth Hospital
Kowloon
Taiwan4 sites
China Medical University Hospital
Taichung
Taichung Veterans General Hospital
Taichung
National Taiwan University Hospital
Taipei
Taipei Veterans General Hospital
Taipei
Malaysia2 sites
Institute Jantung Negara
Kuala Lumpur
Pusat Jantung Sarawak
Kuching
About this study
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.
Read the detailed description
The OPTION-A Study is an observational, prospective, single-arm, multi-center non-mandated post-market study. 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. The objective(s) of the OPTION-A Study is to evaluate safety and effectiveness of catheter ablation with the FARAPULSE™ Pulsed Field Ablation (PFA) System and subsequent implant of Left Atrial Appendage closure (LAAC) with the WATCHMAN™ LAA Closure device in a concomitant procedure.
- Conditions
- Concomitant Procedures, Atrial Fibrillation, PFA, LAAC
- Being tested
- FARAPULSE™ PFA system and WATCHMAN LAAC Delivery Systems
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FARAPULSE™ PFA system and WATCHMAN LAAC Delivery SystemsDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: FARAPULSE™ PFA system and WATCHMAN LAAC Delivery Systems |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: between index procedure and 30 days post index procedure
Secondary outcomes (1)
Device or procedure-related Composite Serious Adverse Events (CSAEs) assessed
Device or procedure-related Composite Serious Adverse Events (CSAEs) assessed at 360 days following the Index Procedure
Measured: 1 year post index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start18 Mar 2025
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Concomitant ProceduresStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 433 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06686485
- Sponsor's protocol ID
- PF316
- Acronym
- OPTION-A
- Status last verified
- Oct 2026
- First submitted
- 8 Nov 2024
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No