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The study is designed to evaluate the safety and performance of the ENDOMATIC SEPIOLA Left Atrial Appendage (LAA) Closure Device in Patients with non-valvular Atrial Fibrillation, who are at increased risk for stroke, and that cannot take, or have a reason to seek an alternative, to long-term anticoagulation therapy.
Potential patients who are candidates for LAA closure will be screened to confirm that all inclusion/exclusion criteria are met, with final eligibility confirmation on day of procedure.
All enrolled subjects who went through the procedure will be followed during the procedure to hospital discharge.
Additional follow up time points are scheduled at 45 days, 6 months and 12 months post procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implantable device | Experimental | Endomatic SEPIOLA System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SEPIOLA System | Device | Implantation of the SEPIOLA device into the left atrial appendage. |
|
| Measure | Description | Time Frame |
|---|---|---|
| SEPIOLA System Safety | Device and Investigational Procedure Related Serious Adverse Events (SAE) | 7 days, 45 days and 6 months post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Device success | Confirmation of functional LAA closure | 45 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Boaz Schwarz | Contact | +972 (0)544595839 | boaz@endomaticmed.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Israeli-Georgian Medical Research Clinic Helsicore | Completed | Tbilisi | 0112 | Georgia | ||
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Tbilisi Heart and Vascular Clinic |
| Completed |
| Tbilisi |
| 0159 |
| Georgia |
| Vilnius university hospital Santaros Klinikos | Recruiting | Vilnius | Lithuania |
|
| Uniwersytecki Szpital Kliniczny w Poznaniu | Recruiting | Poznan | Poland |
|
| Ezgu Niyat | Recruiting | Tashkent | Uzbekistan |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |