The WATCHMAN® Left Atrial Appendage Filter System Pilot Study Investigation

Study of:
The purpose of this study is to demonstrate the safety and effectiveness of the WATCHMAN® device in patients with non-vavular atrial fibrillation (AF) who require treatment for potential thrombus formation (blood clot) and are eligible for warfarin therapy (blood thinning medication). The device is designed to be permanently implanted distal to the ostium of the left atrial appendage (LAA). The WATCHMAN® is intended to prevent the embolization of thrombi that may form in the LAA, thereby preventing the occurrence of ischemic stroke and systemic thromboembolism in AF patients. 50 patients will be enrolled at 5 sites in the United States. All eligible patients will have required follow-up visits at 45 days, 6 months and annually thereafter. A chest x-ray and transesophageal echocardiogram will be completed at the 45 day and 6 month visits.

• Michael R. Mooney, MD, FACC

• Wesley R. Pedersen, MD, FACC
• Anil K. Poulose, MD, FACC

• Holly MacDonald, RN

For more information about this study or the Interventional Cardiology Research program at the Minneapolis Heart Institute and Minneapolis Heart Institute Foundation, please contact Carol Stone at 612-863-9124.