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.
Study Type
OBSERVATIONAL
Enrollment
155
Left Atrial Appendage Occlusion
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.
Time frame: 45 Days post procedure
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.
Time frame: 45 and/or 180 days post procedure
Secondary Safety Endpoint
The secondary safety endpoint is the incidence of serious adverse events at 180 days and one year post-procedure. Serious adverse events are defined as any events that result in death, are life-threatening, require in-patient hospitalization or prolongation of existing hospitalization, or result in permanent or significant disability/incapacity.
Time frame: 180 days and one year post-procedure
Secondary Efficacy Endpoints
1. Procedural success, defined as successful delivery, deployment, and release of the Coherex WaveCrest Left Atrial Appendage Occlusion System into the LAA, and includes successful recapture and retrieval, if necessary. 2. The incidence of LAA occlusion as measured by echocardiographic color flow Doppler jets less than 3mm by TEE at the end of the procedure.
Time frame: intra operative
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