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The purpose of the study is to characterize the performance of the WATCHMAN LAA Closure Device in atrial fibrillation patients for which long term warfarin therapy is contraindicated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WATCHMAN | Experimental | non-valvular atrial fibrillation patients contraindicated to warfarin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WATCHMAN | Device | WATCHMAN LAA Closure Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility study to characterize the performance of the WATCHMAN LAA Closure device in atrial fibrillation patients contracindicated to warfarin treatment | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vivek Reddy, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NA Homolce Hospital | Prague | 150 30 | Czechia | |||
| Sankt Katharinen Hospital / Cardiovasculares Centrum |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23583249 | Derived | Reddy VY, Mobius-Winkler S, Miller MA, Neuzil P, Schuler G, Wiebe J, Sick P, Sievert H. Left atrial appendage closure with the Watchman device in patients with a contraindication for oral anticoagulation: the ASAP study (ASA Plavix Feasibility Study With Watchman Left Atrial Appendage Closure Technology). J Am Coll Cardiol. 2013 Jun 25;61(25):2551-6. doi: 10.1016/j.jacc.2013.03.035. Epub 2013 Apr 10. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 22, 2021 | |
| Reset | Aug 16, 2021 | |
| Release | Oct 26, 2021 | |
| Reset | Nov 29, 2021 | |
| Release | Jan 6, 2022 | |
| Reset | Mar 10, 2022 | |
| Release | Mar 28, 2022 | |
| Reset | Sep 8, 2022 | |
| Release | Oct 3, 2022 | |
| Reset | Aug 10, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 22, 2021 | Aug 16, 2021 | |||
| Oct 26, 2021 |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Frankfurt |
| 60389 |
| Germany |
| Herzzentrum Leipzig | Leipzig | 04289 | Germany |
| Chefarzt der Medizinischen Klinik III/Kardiologie | Regensburg | 93049 | Germany |
| Nov 29, 2021 |
| Jan 6, 2022 | Mar 10, 2022 |
| Mar 28, 2022 | Sep 8, 2022 |
| Oct 3, 2022 | Aug 10, 2023 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |