Rationale and design for AMPLATZER Amulet Left Atrial Appendage Occluder IDE randomized controlled trial (Amulet IDE Trial)

Lakkireddy Dhanunjaya; Windecker Stephan; Thaler David; Sondergaard 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

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Rationale and design for AMPLATZER Amulet Left Atrial Appendage Occluder IDE randomized controlled trial (Amulet IDE Trial)

机译：放大器护身符的理由和设计左心房附件封闭剂IDE随机控制试验（Amulet IDE试验）

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Aims The Amulet IDE Trial is an ongoing, prospective, randomized, multi-national trial, designed to evaluate the safely 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.

机译：Amulet IDE试验是一项持续的，预期的，随机的多国审判，旨在评估Amplatzer Amulet左心房附属封闭盒的安全性和有效性，与非 - 平静的心房颤动。

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来源
《The American heart journal》 |2019年第2019期|共9页
作者
Lakkireddy Dhanunjaya; Windecker Stephan; Thaler David; Sondergaard 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;
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作者单位

Kansas City Heart Rhythm Inst Kansas City KS USA;

Univ Hosp Bern Inselspital Bern Switzerland;

Tufts Med Ctr Boston MA 02111 USA;

Univ Copenhagen Rigshosp Copenhagen Denmark;

Univ Colorado Aurora CO USA;

Med Univ South Carolina Charleston SC 29425 USA;

Abbott Plymouth MN USA;

Abbott Plymouth MN USA;

St Vincent Med Grp Indianapolis IN USA;

Univ Hosp Essen Essen Germany;

Cardioangiol Ctr Bethanien Frankfurt Germany;

South Denver Cardiol Associates Littleton CO USA;

Massachusetts Gen Hosp Boston MA 02114 USA;

Florida Atlantic Univ Tenet Florida Boca Raton FL 33431 USA;

St Francis Hosp Roslyn NY USA;

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正文语种 eng
中图分类心脏、血管（循环系）疾病;
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1. Rationale and design for AMPLATZER Amulet Left Atrial Appendage Occluder IDE randomized controlled trial (Amulet IDE Trial) [J] . Lakkireddy Dhanunjaya, Windecker Stephan, Thaler David, The American heart journal . 2019,第期

机译：放大器护身符的理由和设计左心房附件封闭剂IDE随机控制试验（Amulet IDE试验）
2. Left Atrial Appendage Occlusion with Amplatzer Cardiac Plug and Amplatzer Amulet: a Clinical Trials Update [J] . Journal of Atrial Fibrillation . 2017,第4期

机译：Amplatzer心脏塞和Amplatzer护身符对左心耳的阻塞：临床试验更新
3. Length of stay following percutaneous left atrial appendage occlusion: Data from the prospective, multicenter Amplatzer Amulet Occluder Observational Study [J] . Kerstin Piayda, Shazia Afzal, Jens Erik Nielsen-Kudsk, PLoS One . 2021,第8期

机译：经皮左心房附属闭塞后的逗留时间：来自前瞻性的数据，多中心放大器Amulet封堵器观测研究
4. Rationale, Design and Preliminary Results of ROMEO (Rethink Organization to Improve Education and Outcomes) A Randomized Controlled Multicenter Trial of Group Care in the Management ofType 1 Diabetes [C] . M. Porta, M. Trent European Association for the Study of Diabetes . 2005

机译：Romeo（重新思考组织改善教育和结果）的基本理由，设计和初步结果，在1型糖尿病的术语中进行了随机对照的组织的多中心试验
5. A 4-month randomized controlled clinical trial of adjuvant Exenatide or Pramlintide versus insulin alone in pediatric type 1 diabetes mellitus: Effect on glycemic control. [D] . Withycombe, Sarah Elizabeth. 2010

机译：儿科1型糖尿病患者中艾塞那肽或普兰林肽与单独使用胰岛素的4个月随机对照临床试验：对血糖控制的影响。
6. Value of FEops HEARTguide patient-specific computational simulations in the planning of left atrial appendage closure with the Amplatzer Amulet closure device: rationale and design of the PREDICT-LAA study [O] . Philippe Garot, Xavier Iriart, Adel Aminian, 2020

机译：FSOPS心指导指示患者特定的计算模拟在左心房附件封闭规划中的左侧闭合装置：预测LAA研究的理由和设计
7. Value of FEops HEARTguide patient-specific computational simulations in the planning of left atrial appendage closure with the Amplatzer Amulet closure device: rationale and design of the PREDICT-LAA study [O] . Philippe Garot, Xavier Iriart, Adel Aminian, 2020

机译：FSOPS心指导指示患者特定的计算模拟在左心房附件封闭规划中的左侧闭合装置：预测LAA研究的理由和设计

Rationale and design for AMPLATZER Amulet Left Atrial Appendage Occluder IDE randomized controlled trial (Amulet IDE Trial)

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