OPTION-EMEA Clinical Trial

Sponsor
Boston Scientific Corporation
Study ID
NCT07349121
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Concomitant pulsed field ablation (PFA) and left atrial appendage closure (LAAC) during one interventional case — DEVICE
    left atrial appendage closure
  • Concomitant Pulsed Field Ablation and Left Atrial Appendage Closure — PROCEDURE
    FARAPULSE PFA and WATCHMAN FLX Pro or WATCHMAN FLX in one interventional case.

Study Details

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.

Key Dates

First listed
Jan 16, 2026
Start date
Jun 18, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
500 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Other: Single arm study
    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.

Primary Outcome Measure

Primary Safety Endpoint (PSE): Device or Procedure Related Serious Adverse Events [ Time Frame: 30 days following the index procedure. ]

Central Contacts

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