RecruitingNot ApplicableNCT07349121

OPTION-EMEA Clinical Trial

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

Sponsor

Boston Scientific Corporation

Enrollment

500 participants

Start Date

Jun 18, 2026

Study Type

INTERVENTIONAL

Conditions

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

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Concomitant Pulsed Field Ablation and Left Atrial Appendage Closure and a medical device called Concomitant pulsed field ablation (PFA) and left atrial appendage closure (LAAC) during one interventional case for people with atrial fibrillation (af), atrial fibrillation ablation procedure, and other related conditions. The study is currently recruiting participants at 3 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.