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| Name | Class |
|---|---|
| Premier Research | OTHER |
| IQVIA Pty Ltd | INDUSTRY |
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Watchman FLX Left Atrial Appendage Closure Device Post Approval Study
WATCHMAN FLX is intended to prevent thrombus embolization from the left atrial appendage and reduce the risk of life-threatening bleeding events in patients with non-valvular atrial fibrillation who are eligible for anticoagulation therapy or who have a contraindication to anticoagulation therapy.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Watchman FLX | Device | Patients who are receiving the Watchman FLX device |
| Measure | Description | Time Frame |
|---|---|---|
| procedural success | 7 days post-implant | |
| incidence of stroke, leak, thrombus and death | 1 year | |
| procedural complications | 7-days post implant |
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Inclusion Criteria:
Exclusion Criteria:
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All subjects who meet all inclusion and no exclusion criteria can be enrolled. A subject who signs informed consent is considered enrolled in the study. The subjects selected for participation will be from the investigator's general patient population.
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| Name | Affiliation | Role |
|---|---|---|
| Timothy Betts | John Radcliffe Hospital, Oxford, UK | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Aarhus | Denmark | ||||
| Hospices Civils de Lyon |
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| Lyon |
| France |
| Elisabeth Krankenhaus | Essen | Germany |
| Cardio Vasculares Centrum Sankt Katharinen | Frankfurt | Germany |
| Cardioangiologisches Centrum Bethanien | Frankfurt | Germany |
| Cardiologicum Hamburg | Hamburg | 22041 | Germany |
| Uni Jena | Jena | Germany |
| Herzzentrum Universität Leipzig | Leipzig | Germany |
| Beaumont Hospital | Dublin | Ireland |
| Ospedale San Raffaele | Milan | Italy |
| Ospedale San Francesco | Nuoro | Italy |
| St. Antonius Hospital | Nieuwegein | Netherlands |
| Clinical Hospital University of Medicine | Poznan | Poland |
| Hospital De La Santa Creu I Sant Pau | Barcelona | Spain |
| Hospital Virgen Macarena | Seville | Spain |
| Royal Sussex County Hospital | Brighton | United Kingdom |
| John Radcliffe Hospital | Oxford | United Kingdom |