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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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Atrial fibrillation (AF) is the most common cardiac arrhythmia with a lifetime risk of developing AF of 1 in 4 people aged over 40. Stroke remains the most feared complication of AF with an increase in risk by 5-fold, and is the leading cause of morbidity and mortality. The left atrial appendage (LAA) is the origin for more than 90% of the emboli in non-valvular AF. The WATCHMANâ„¢ Left Atrial Closure Device (WATCHMAN Device, Boston Scientific) reduces the risk of stroke by closing off the LAA. During hybrid procedures for AF, LAA occlusion with epicardial devices is known to be difficult and not free of risks.It thus will be interesting to study the safety and feasibility of endocardial WATCHMAN Device implantation in a hybrid ablation approach.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WATCHMAN Implantation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WATCHMAN Device implantation | Device | The implantation of the device will be done into the left atrial appendage according to the guidelines. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major complications during follow-up, assessed by scoring the number of complications | 6 months | |
| Device success, assessed by transesophageal echocardiogram. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
Echocardiographic Exclusion Criteria (as assessed via transthoracic echocardiography (TTE) or TEE) for this study are:
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| Name | Affiliation | Role |
|---|---|---|
| Laurent Pison, MD, PhD | Maastricht University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University Medical Center | Maastricht | Limburg | 6229HX | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31772531 | Derived | Vroomen M, Maesen B, Luermans JG, Crijns HJ, Maessen JG, La Meir M, Pison L. Left Atrial Appendage Management with the Watchman Device during Hybrid Ablation of Atrial Fibrillation. J Interv Cardiol. 2019 Jun 26;2019:4525084. doi: 10.1155/2019/4525084. eCollection 2019. |
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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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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |