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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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Left atrial appendage (LAA) occlusion with WatchmanTM has emerged as viable alternative to anticoagulation therapy in randomized controlled trials. The device has FDA approved since 2015 and the firsts Latin American cases were performed in 2012. However, there is no real world data from Latin American experience in terms of success and outcomes.
Approximately 450 subjects will be enrolled in the study. Up to 50 sites in Latin America will participate in the study.
Primary analyses may include, but will not be limited to, the following: procedural complications, incidence of stroke and death. Descriptive statistics will be used for baseline, procedure and follow-up data collected through the registry.
Clinical history of each patient will be analyzed for a period of 6 months after the procedure according the standard practice at the enrolling centers. There will be no additional visits, nor procedures, for subjects in the registry.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Left atrial appendage closure with Watchman device | Device | Percutaneous left atrial appendage closure using Watchman device |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Periprocedural complications | Pericardial effusion, stroke, device embolization and bleeding | At implant |
| Incidence of Stroke | Stroke | 6 months follow up |
| Incidence of Death | Cardiovascular and no cardiovascular death | 6 months follow up |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with atrial fibrillation and indication for left atrial appendage closure
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Medico Docente la Trinidad | Caracas | Miranda | 1080 | Venezuela |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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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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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |