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NOT YET RECRUITING
NCT07349121
NA

OPTION-EMEA Clinical Trial

Sponsor: Boston Scientific Corporation

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

500

Start Date

2026-04

Completion Date

2028-12

Last Updated

2026-03-13

Healthy Volunteers

No

Interventions

DEVICE

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

left atrial appendage closure

PROCEDURE

Concomitant Pulsed Field Ablation and Left Atrial Appendage Closure

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

Locations (2)

Clinique Pasteur - Toulouse

Toulouse, France

University Hospital of Salamanca

Salamanca, Spain