Trials / Not Yet Recruiting
Not Yet RecruitingNCT07349121
OPTION-EMEA Clinical Trial
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation - Europe, Middle East and Africa [OPTION-EMEA]
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2026-04-01
- Primary completion
- 2028-12-01
- Completion
- 2028-12-01
- First posted
- 2026-01-16
- Last updated
- 2026-04-14
Locations
2 sites across 2 countries: France, Spain
Source: ClinicalTrials.gov record NCT07349121. Inclusion in this directory is not an endorsement.