WUH: AMPLATZER Amulet Left Atrial Appendage (LAA) Occluder Randomized Controlled Trial

Brief description of study

The purpose of the AMPLATZER Amulet Left Atrial Appendage (LAA) Occluder Trial is to find out if the Amulet device is safe and effective when compared to another LAA closure device made by another Medical Device Company named Boston Scientific. The other device, called the WATCHMAN LAA closure device, is approved for use in the United States and many countries in Europe, Australia, and other nations. It is implanted in some patients with non-valvular atrial fibrillation to reduce the risk of stroke. To assess the safety of the Amulet device, the study will be collecting information on complication rates, including those related to the procedure or device, bleeding events, and deaths. The number of ischemic strokes and systemic embolisms (blood clots that travel through your body and become stuck in an artery, blocking blood flow) will be used to evaluate if the Amulet device works as it is intended to. How well the device closes your LAA and the use of warfarin or other anticoagulant(s) after the device is implanted will also be used to evaluate the device. The data collected during this trial will be used to support the Food and Drug Administration (FDA) approval of the Amulet device in the United States (US) as well as other countries, as needed.


Clinical Study Identifier: s18-00893
ClinicalTrials.gov Identifier: NCT02879448
Principal Investigator: Joseph J. Germano.


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