cOncomitant Left Atrial aPpendage Closure and Pulsed Field ablaTION-Asia

Last updated: January 22, 2026
Sponsor: Boston Scientific Corporation
Overall Status: Active - Recruiting

Phase

N/A

Condition

Arrhythmia

Chest Pain

Dysrhythmia

Treatment

FARAPULSE™ PFA system and WATCHMAN LAAC Delivery Systems

Clinical Study ID

NCT06686485
PF316
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Clinically indicated for treatment with both the FARAPULSE™ PFA system and withWATCHMAN for LAAC, per physician medical judgement and as per hospitals' standard ofcare.

  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 thisclinical study at an approved clinical investigational center.

  4. Subjects whose age is 18 years or above, or who are of legal age to give informedconsent specific to state and national law.

Exclusion

Exclusion Criteria:

  1. Subjects who underwent prior AF ablation procedure.

  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 repairor 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) ortransient 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 congenitalabnormalities (severe rotational anomalies of the heart or great vessels) arepresent*.

  14. Subjects with any contraindications to short term use of anticoagulation therapy, oraspirin 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 registrythat would directly interfere with the current study, except when the subject isparticipating in a mandatory governmental registry, or a purely observationalregistry with no associated treatments. Each instance must be reviewed by thesponsor to determine eligibility.

Study Design

Total Participants: 433
Treatment Group(s): 1
Primary Treatment: FARAPULSE™ PFA system and WATCHMAN LAAC Delivery Systems
Phase:
Study Start date:
March 18, 2025
Estimated Completion Date:
October 31, 2029

Study 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.

Connect with a study center

  • The First Affiliated Hospital of Soochow University

    Suzhou 1886760, Jiangsu 1806260
    China

    Active - Recruiting

  • Beijing Anzhen Hospital of the Capital University of Medical Sciences

    Beijing,
    China

    Site Not Available

  • Beijing Anzhen Hospital of the Capital University of Medical Sciences

    Beijing 1816670,
    China

    Active - Recruiting

  • Huaxi Hospital of Sichuan University

    Chengdu,
    China

    Site Not Available

  • Huaxi Hospital of Sichuan University

    Chengdu 1815286,
    China

    Active - Recruiting

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang,
    China

    Site Not Available

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang 1809461,
    China

    Active - Recruiting

  • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine

    Hangzhou 1808926,
    China

    Active - Recruiting

  • QiLu Hospital of ShanDong University

    Jinan 1805753,
    China

    Active - Recruiting

  • Shanxi Cardiovascular Hospital

    Taiyuan 1793511,
    China

    Active - Recruiting

  • Zigong First People's Hospital

    Zigong 1783745,
    China

    Active - Recruiting

  • Prince of Wales Hospital

    Hong Kong,
    Hong Kong

    Active - Recruiting

  • Queen Mary Hospital

    Hong Kong,
    Hong Kong

    Site Not Available

  • Prince of Wales Hospital

    Hong Kong 1819729,
    Hong Kong

    Active - Recruiting

  • Princess Margaret Hospital

    Hong Kong 1819729,
    Hong Kong

    Active - Recruiting

  • Queen Mary Hospital

    Hong Kong 1819729,
    Hong Kong

    Active - Recruiting

  • Queen Elizabeth Hospital

    Kowloon 1819609,
    Hong Kong

    Active - Recruiting

  • Shonan Kamakura General Hospital

    Kamakura-shi, Kanagawa 1860291
    Japan

    Active - Recruiting

  • Sendai Kousei Hospital

    Sendai 2111149, Miyagi 2111888
    Japan

    Active - Recruiting

  • Kurashiki Central Hospital

    Kurashiki-shi, Okayama Kurashiki-shi
    Japan

    Active - Recruiting

  • Saitama Red Cross Hospital

    Saitama 6940394, Saitama 1853226
    Japan

    Active - Recruiting

  • Sakakibara Heart Institute, Sakakibara Heart Foundation

    Fuchu-shi, Tokyo 1850144
    Japan

    Active - Recruiting

  • Kokura Memorial Hospital

    Fukuoka-ken,
    Japan

    Active - Recruiting

  • Yokosuka Kyosai Hospital

    Kanagawa 1860292,
    Japan

    Active - Recruiting

  • Toho University Ohashi Medical Center

    Meguro-ku,
    Japan

    Active - Recruiting

  • Osaka Keisatsu Hospital

    Osaka,
    Japan

    Site Not Available

  • Osaka Keisatsu Hospital

    Osaka 1853909,
    Japan

    Active - Recruiting

  • Institute Jantung Negara

    Kuala Lumpur,
    Malaysia

    Site Not Available

  • Institute Jantung Negara

    Kuala Lumpur 1735161,
    Malaysia

    Active - Recruiting

  • Pusat Jantung Sarawak

    Kuching 1735634,
    Malaysia

    Active - Recruiting

  • Asian Heart and Vascular Centre

    Singapore 1880252,
    Singapore

    Active - Recruiting

  • Taichung Veterans General Hospital

    Taichung 1668399,
    Taiwan

    Active - Recruiting

  • Taipei Veterans General Hospital

    Taipei,
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei 1668341,
    Taiwan

    Active - Recruiting

  • Taipei Veterans General Hospital

    Taipei 1668341,
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital

    Taipei city,
    Taiwan

    Site Not Available

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