Rationale and design for AMPLATZER Amulet Left Atrial Appendage Occluder IDE randomized controlled trial (Amulet IDE Trial)
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Rationale and design for AMPLATZER Amulet Left Atrial Appendage Occluder IDE randomized controlled trial (Amulet IDE Trial). / Lakkireddy, Dhanunjaya; Windecker, Stephan; Thaler, David; Søndergaard, Lars; Carroll, John; Gold, Michael R; Guo, Hongfei; Brunner, Kyle J; Hermiller, James B; Diener, Hans-Christoph; Schmidt, Boris; MacDonald, Lee; Mansour, Moussa; Maini, Brijeshwar; Levine, Joseph.
I: American Heart Journal, Bind 211, 2019, s. 45-53.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - Rationale and design for AMPLATZER Amulet Left Atrial Appendage Occluder IDE randomized controlled trial (Amulet IDE Trial)
AU - Lakkireddy, Dhanunjaya
AU - Windecker, Stephan
AU - Thaler, David
AU - Søndergaard, Lars
AU - Carroll, John
AU - Gold, Michael R
AU - Guo, Hongfei
AU - Brunner, Kyle J
AU - Hermiller, James B
AU - Diener, Hans-Christoph
AU - Schmidt, Boris
AU - MacDonald, Lee
AU - Mansour, Moussa
AU - Maini, Brijeshwar
AU - Levine, Joseph
PY - 2019
Y1 - 2019
N2 - The 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. METHODS: Non-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 through 12 months (safety); a composite of ischemic stroke or systemic embolism through 18 months (effectiveness); and effective device LAAO, defined as residual jet around the device ≤5 mm at the 45-day visit (mechanism of action). SUMMARY: The Amulet IDE Trial is the first randomized head-to-head LAAO device trial and will provide data for the AMPLATZER Amulet occluder in a population with a high risk of stroke and bleeding.
AB - The 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. METHODS: Non-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 through 12 months (safety); a composite of ischemic stroke or systemic embolism through 18 months (effectiveness); and effective device LAAO, defined as residual jet around the device ≤5 mm at the 45-day visit (mechanism of action). SUMMARY: The Amulet IDE Trial is the first randomized head-to-head LAAO device trial and will provide data for the AMPLATZER Amulet occluder in a population with a high risk of stroke and bleeding.
KW - Anticoagulants/adverse effects
KW - Atrial Fibrillation/complications
KW - Cardiac Catheterization
KW - Cardiac Surgical Procedures/adverse effects
KW - Cause of Death
KW - Fibrinolytic Agents/adverse effects
KW - Hemorrhage/chemically induced
KW - Humans
KW - Postoperative Complications
KW - Prospective Studies
KW - Prosthesis Design
KW - Risk Factors
KW - Septal Occluder Device/adverse effects
KW - Stroke/etiology
U2 - 10.1016/j.ahj.2018.12.010
DO - 10.1016/j.ahj.2018.12.010
M3 - Journal article
C2 - 30831333
VL - 211
SP - 45
EP - 53
JO - American Heart Journal
JF - American Heart Journal
SN - 0002-8703
ER -
ID: 241841130