Stroke Feasibility Study
If you are at 18-80 years of age with Atrial Fibrillation (AF) and cannot take long-term oral anticoagulation therapy, you may qualify to be part of this Clinical Study to evaluate a procedure using the AtriClip® Left Atrial Appendage Exclusion System for stroke prevention.
While participating in this study, outcomes data on your procedure will be documented and you will be asked to complete assessments so that the sponsor can learn more about your experience with this procedure.
As a minimally invasive surgical procedure, the surgeon will make small incisions in the chest wall to place the AtriClip device directly onto the base of the left atrial appendage (LAA) while the heart is still beating. Complete exclusion of the LAA is confirmed during the procedure using echo graphic imaging. Three months following the procedure, a computerized tomography (CT) scan will be performed to re-confirm complete and permanent LAA exclusion.
1January, C., Wann S., Alpert J., Calkins H., Cleveland J., Cigarroa J., Conti J., Ellinor P., “2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society.” Circulation. 2014 March.
The AtriClip® LAA Exclusion System has been cleared by the US Food and Drug Administration (FDA) for occlusion of the left atrial appendage, under direct visualization, in conjunction with other cardiac surgical procedures. It has not been approved for the prevention of stroke and FDA has not determined that it is safe or effective in preventing stroke.