OPTION-EMEA Clinical Trial
← catalyst calendarNCT07349121 · readout ≤ 865 d
Sponsored by Boston Scientific Corporation (industry) · BSX — their whole pipeline →.
Phase
Not applicable
Status
Recruiting
Study type
Interventional
Design
Na · None · Other
Enrollment
500estimated
Sites
5
Countries
Belgium, Croatia, France +2
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-06-18 | actual | When the study began enrolling |
| Primary completion | Dec 2028 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Dec 2029 | estimated | The whole study's end, after follow-up |
| First posted | 2026-01-16 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-05 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
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
- Procedure: Concomitant Pulsed Field Ablation and Left Atrial Appendage Closure
Primary outcomes
what the primary-completion date above is the date OFPrimary Safety Endpoint (PSE): Device or Procedure Related Serious Adverse Events
measured 30 days following the index procedure.
Primary Efficacy Endpoint (PEE): Acute Treatment Success
measured Through 30 days
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