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The objective is to assess the effectiveness of permanent exclusion of the LAA with the LARIAT RS Suture Delivery Device and accessories in AF patients.
Prospective, observational, single-center, non-randomized study of a stand-alone procedure for the exclusion of the LAA with the LARIAT RS in patients with atrial fibrillation. Completed LAA exclusion will be assessed by TEE.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LAA exclusion procedure | Experimental | LAA exclusion with the LARIAT RS Suture Delivery Device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LARIAT RS Suture Delivery Device | Device | LARIAT RS Suture Delivery Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of subjects with complete exclusion | To assess the rate of complete exclusion of the LAA measured by color duplex TEE at 4 time points: Acute (i.e., immediately after LAA exclusion procedure), 1 day, 1 month, and 3 month. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Exploratory objectives of procedural success and device-related complication rates |
| 3 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jagiellonian University (John Paul II) Hospilal | Krakow | Poland |
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