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PROTECT AF: Difference between revisions
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==Design== | ==Design== | ||
* Multicenter, open label, randomized control trial. | * Multicenter, open label, randomized control trial. | ||
* N= 707 | * '''N= 707''' | ||
** Intervention: N=463 | ** Intervention: N=463 | ||
** Control: N=244 | ** Control: N=244 | ||
* Setting: | * '''Setting:''' 59 centers in USA, Czech Republic and Germany | ||
* Enrollment: February 2005 | * '''Enrollment:''' February 2005 to June 2008 | ||
* Mean Follow-up: 18 months | * '''Mean Follow-up:''' 18 months | ||
* Analysis: Intention to treat | * '''Analysis:''' Intention to treat | ||
* Primary | * '''Primary Efficacy Endpoint:''' Composite of stroke (including ischemic and hemorrhagic), systemic embolism and cardiovascular or unexplained death | ||
* '''Primary Safety Endpoint:''' Composite of excessive bleeding (eg. intracranial or GI bleeding) or procedure-related complications (eg. serious pericardial effusion, device embolization, procedure-related stroke) | |||
==Population== | ==Population== | ||