Rationale and design for AMPLATZER™ amulet™ left atrial appendage Occluder IDE randomized controlled trial (amulet IDE trial)

Publication date: Available online 21 December 2018Source: American Heart JournalAuthor(s): Dhanunjaya Lakkireddy, Stephan Windecker, David Thaler, Lars Sondergaard, John Carroll, Michael R Gold, Hongfei Guo, Kyle J Brunner, James B Hermiller, Hans-Christoph Diener, Boris Schmidt, Lee MacDonald, Moussa Mansour, Brijeshwar Maini, Joseph LevineAbstractAimsThe Amulet IDE Trial is an ongoing, prospective, randomized, multi-national trial, designed to evaluate the safety and effectiveness of the AMPLATZER™ Amulet™ Left Atrial Appendage Occluder for stroke prevention in comparison to the WATCHMAN Left Atrial Appendage Closure Device in patients with non-valvular atrial fibrillation.MethodsNon-valvular atrial fibrillation patients at high risk of stroke (CHADS2 score ≥ 2 or a CHA2DS2-VASc score of ≥3) who are suitable candidates for left atrial appendage occlusion (LAAO) will be fully informed and requested to participate in the trial. A total of 1878 patients at up to 150 sites worldwide will be randomized in a 1:1 ratio between the AMPLATZER Amulet device (investigational) and the Boston Scientific WATCHMAN device (control). Each patient will be followed for 5 years, with follow-up assessments at discharge, 45 days, 3, 6, 9, 12, 18, and 24 months and then annually. The trial has three primary endpoints: A composite of procedure-related complications, or all-cause death, or major bleeding (safety) through 12 months; a composite of ischemic stro...
Source: American Heart Journal - Category: Cardiology Source Type: research