OPTION-EMEA Clinical Trial

NCT07349121 | Recruiting

• 1 other identifier: S2605
• Study Type: interventional
• Target: 500
• Locations: 3 countries
• Sites: 3

Brief 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.

Conditions

Atrial Fibrillation (AF); Left Atrial Appendage Closure; Stroke Prevention in Patients With Atrial Fibrillation; Pulsed Field Ablation; Atrial Fibrillation Ablation Procedure; Concomitant Procedures

Keywords

WATCHMAN; FARAPULSE; Concomitant; PFA; LAAC

Outcome Measures

Primary Outcomes (2)

• Primary Safety Endpoint (PSE): Device or Procedure Related Serious Adverse Events

  The PSE is the proportion of subjects who experience one or more device- or procedure-related composite serious adverse events (CSAEs) assessed at 30 days following the index procedure.

  30 days following the index procedure.

• Primary Efficacy Endpoint (PEE): Acute Treatment Success

  The PEE is the proportion of subjects with Acute Treatment Success assessed among those receiving ≥ 1 PFA application and who have WATCHMAN device deployment attempted or successfully implanted.

  Through 30 days

Study Arms (1)

Single arm study

OTHER

Subjects who meet eligibility criteria will undergo AF ablation and left atrial appendage closure using the FARAPULSE PFA system and WATCHMAN FLX Pro or WATCHMAN FLX during one interventional case.

Device: Concomitant pulsed field ablation (PFA) and left atrial appendage closure (LAAC) during one interventional case; Procedure: Concomitant Pulsed Field Ablation and Left Atrial Appendage Closure

Interventions

Concomitant Pulsed Field Ablation and Left Atrial Appendage Closure PROCEDURE

FARAPULSE PFA and WATCHMAN FLX Pro or WATCHMAN FLX in one interventional case.

Single arm study

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

left atrial appendage closure

Single arm study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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 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.

You may not qualify if:

• 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\*.
• 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.
• Subjects with a presence of a mechanical valve prosthesis in any position.
• Subjects with a myocardial infarction within 90 days prior to enrollment.
• Subjects had a prior stroke (of any cause, whether ischemic or hemorrhagic) or transient ischemic attack (TIA) within 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) 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).
• Subjects with any contraindications to short term use of anticoagulation therapy for conditions different from atrial fibrillation.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (3)

Klinicki bolnicki centar Zagreb

Zagreb, Croatia

RECRUITING

Clinique Pasteur - Toulouse

Toulouse, France

NOT YET RECRUITING

University Hospital of Salamanca

Salamanca, Spain

NOT YET RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Left Atrial Appendage Closure

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiac Catheterization; Catheterization; Therapeutics; Investigative Techniques

Central Study Contacts

Katherine A Beattie, Sr. Clinical Trial Manager, RN

CONTACT

+1 612 819 4540; Katherine.beattie@bsci.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 16, 2026
• Study Start: June 18, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1); ES (1); FR (1)