Anticoagulation Indication for Potential Thrombus Formation in the Left Atrium Clinical Trial
Official title:
Coherex WAVECREST I Left Atrial Appendage Occlusion Study
Purpose To establish the safety and efficacy of the Coherex WaveCrest Left Atrial Appendage Occlusion System for left atrial appendage (LAA) closure during treatment of non-valvular atrial fibrillation in patients who are at increased risk for embolic stroke and have an ongoing indication for oral anticoagulation.
Primary Safety Endpoint The primary safety endpoint is the incidence of major adverse events
up to 45 days post-procedure. Major adverse events are defined as life-threatening incidents
as determined by the Clinical Events Committee (CEC) and include events such as device
embolization; cardiac injury, re-intervention, and/or device-related surgery; bleeding
events such as pericardial effusion requiring drainage, cranial bleeding due to any source,
gastrointestinal bleeding; or any other event related to the device or the procedure, which
requires treatment.
Primary Efficacy Endpoint The primary efficacy endpoint is the incidence of LAA occlusion at
45 and/or 180 days (+ten days) post-procedure. LAA occlusion will be assessed by
transesophageal echocardiography (TEE) color flow Doppler and will be defined as absence of
flow in the LAA or color flow Doppler jets less than 3mm.
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Observational Model: Cohort, Time Perspective: Prospective