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RECRUITING

cOncomitant Left Atrial aPpendage Closure and Pulsed Field ablaTION-Asia

NCT06686485•Boston Scientific Corporation

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.

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 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.
•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 this clinical study at an approved clinical investigational center.
•4. Subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law.

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 repair or 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) or transient ischemic attack (TIA) within the 90 days prior to enrollment.
+7 more criteria

Locations (29)

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

Shanxi Cardiovascular Hospital

Taiyuan, China

Zigong First People's Hospital

Zigong, China

Key Dates

Start Date

March 18, 2025

Primary Completion Date

October 31, 2026

Completion Date

October 31, 2029

Last Updated

March 2, 2026

Enrollment

433

ESTIMATED participants

Conditions

Concomitant ProceduresAtrial FibrillationPFALAAC

Interventions

FARAPULSE™ PFA system and WATCHMAN LAAC Delivery Systems

DEVICE

Contacts

Jamie Kwek

CONTACT

+6564188833 Jamie.Kwek@bsci.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 2, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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cOncomitant Left Atrial aPpendage Closure and Pulsed Field ablaTION-Asia

Inclusion Criteria

Exclusion Criteria

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