Coherex WaveCrest Left Atrial Appendage Occlusion Study A multi-center study to evaluate the safety and efficacy of the Coherex WaveCrest Left Atrial Appendage Occlusion System
A Feasibility study of 200 patients with non-valvular atrial fibrillation and an ongoing indication for anticoagulation to prevent embolic stroke that will have left atrial appendage closure with the Coherex Left Atril Appendage Occlusion System to evaluate the safety and efficacy of the device in preventing embolic stroke.
Coherex Medical Inc.
200 participants
Oct 20, 2010
Interventional
Conditions
Summary
The primary study objective is to verify that under normal conditions of use the Coherex Left Atrial Appendage Occlusion System is a safe and effective LAA occlusion device. This investigation will be accomplished by: 1) implanting the device in patients with non-valvular paroxysmal, persistent, or permanent atrial fibrillation when anticoagulation is indicated for potential thrombus formation in the left atrium; 2) assessing LAA occlusion; and 3) monitoring adverse events at 45 days and/or up to one year post procedure. The study will also be designed to demonstrate the safety of the Coherex Left Atrial Appendage Occlusion System by assessing: 1) ease of successful device insertion; 2) positioning accuracy; 3) placement stability; and 4) post-procedure adverse events. To achieve this objective, data will be collected before, during, and after the procedure.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
The Coherex Left Atrial Appendage Occlusion System is a permanent implant to close the orifice of the left atrial appendage and will be placed during a one hour percutaneous transcatheter intervention. Post procedurte patients will be monitored for adverse events and in particular the occurance of thrombolic events originating from the left heart for a minimum of one year.
Locations(4)
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ACTRN12610000921088