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OPTION-EMEA Clinical Trial

NCT07349121 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2026-05-08

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • France
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07349121 on ClinicalTrials.gov