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The primary objective of this study is to assess the efficacy and safety of using intra-procedural intracardiac echocardiography (ICE) for WATCHMAN FLX Device implants in subjects with non-valvular atrial fibrillation to reduce the risk of stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single-arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intra-procedural intracardiac echocardiography | Device | use of intra-procedural intracardiac echocardiography during Watchman FLX devices |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Device Leak | Rate of significant leak (>5 mm) as assessed by TEE at 45 days' post-implant. | 45 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jens Erik Nielsen-Kudsk, MD | Aarhus University Hospital Skejby | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus Universitetshospital | Skejby | Denmark | ||||
| Fondazione Toscana Gabriele Monasterio |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36764917 | Derived | Nielsen-Kudsk JE, Berti S, Caprioglio F, Ronco F, Arzamendi D, Betts T, Tondo C, Christen T, Allocco DJ. Intracardiac Echocardiography to Guide Watchman FLX Implantation: The ICE LAA Study. JACC Cardiovasc Interv. 2023 Mar 27;16(6):643-651. doi: 10.1016/j.jcin.2022.10.024. Epub 2023 Feb 8. |
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| Massa |
| Italy |
| Ospedale dell'Angelo | Mestre | Italy |
| Centro Cardiologico Fondazione Monzino | Milan | Italy |
| Ospedale San Bortolo | Vicenza | Italy |
| Hospital de Sant Pau | Barcelona | Spain |
| John Radcliffe | Oxford | United Kingdom |