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OPTION-EMEA Clinical Trial | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGNA

OPTION-EMEA Clinical Trial

Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation - Europe, Middle East and Africa [OPTION-EMEA]

NCT07349121•Boston Scientific Corporation

Summary

The OPTION-EMEA post-market study is intended to gather real world clinical data for patients undergoing AF ablation with the FARAPULSE™ Pulsed Field Ablation (PFA) System and subsequent left atrial appendage closure (LAAC) with a WATCHMAN FLX™ Pro or WATCHMAN FLX device during one interventional case. The study will include patients that are clinically indicated for atrial fibrillation (AF) ablation using the FARAPULSE PFA System and for left atrial appendage closure (LAAC) treatment using a WATCHMAN FLX Pro or WATCHMAN FLX device as part of the patient's standard of care determined by their doctor's medical judgement.

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 FLX™ Pro or WATCHMAN FLX™ 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 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 atrial septal defect (ASD) / patent foramen ovale (PFO) device.
•8. Subjects with a presence of a mechanical valve prosthesis in any position.
•9. Subjects with a myocardial infarction within 90 days prior to enrollment.
•10. Subjects had a prior stroke (of any cause, whether ischemic or hemorrhagic) or transient ischemic attack (TIA) within 90 days prior to enrollment.
+8 more criteria

Locations (2)

Clinique Pasteur - Toulouse

Toulouse, France

University Hospital of Salamanca

Salamanca, Spain

Key Dates

Start Date

April 1, 2026

Primary Completion Date

December 1, 2028

Completion Date

December 1, 2028

Last Updated

March 13, 2026

Enrollment

500

ESTIMATED participants

Conditions

Atrial Fibrillation (AF)Stroke Prevention in Patients With Atrial FibrillationLeft Atrial Appendage ClosurePulsed Field AblationAtrial Fibrillation Ablation ProcedureConcomitant Procedures

Interventions

Concomitant pulsed field ablation (PFA) and left atrial appendage closure (LAAC) during one interventional case

DEVICE

Concomitant Pulsed Field Ablation and Left Atrial Appendage Closure

PROCEDURE

Contacts

Katherine A Beattie, Sr. Clinical Trial Manager, RN

CONTACT

+1 612 819 4540 Katherine.beattie@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 13, 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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OPTION-EMEA Clinical Trial

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