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The OPTION-EMEA post-market study is intended to gather real world clinical data for patients undergoing AF ablation with the FARAPULSEâ„¢ Pulsed Field Ablation (PFA) System and subsequent left atrial appendage closure (LAAC) with a WATCHMAN FLXâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm study | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Concomitant pulsed field ablation (PFA) and left atrial appendage closure (LAAC) during one interventional case | Device | left atrial appendage closure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Safety Endpoint (PSE): Device or Procedure Related Serious Adverse Events | The PSE is the proportion of subjects who experience one or more device- or procedure-related composite serious adverse events (CSAEs) assessed at 30 days following the index procedure. | 30 days following the index procedure. |
| Primary Efficacy Endpoint (PEE): Acute Treatment Success | The PEE is the proportion of subjects with Acute Treatment Success assessed among those receiving ≥ 1 PFA application and who have WATCHMAN device deployment attempted or successfully implanted. | Through 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katherine A Beattie, Sr. Clinical Trial Manager, RN | Contact | +1 612 819 4540 | Katherine.beattie@bsci.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinicki bolnicki centar Zagreb | Recruiting | Zagreb | Croatia |
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| Concomitant Pulsed Field Ablation and Left Atrial Appendage Closure | Procedure | FARAPULSE PFA and WATCHMAN FLX Pro or WATCHMAN FLX in one interventional case. |
|
| Clinique Pasteur - Toulouse | Not yet recruiting | Toulouse | France |
|
| University Hospital of Salamanca | Not yet recruiting | Salamanca | Spain |
|
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000097546 | Left Atrial Appendage Closure |
| ID | Term |
|---|---|
| D006328 | Cardiac Catheterization |
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
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