临床试验/NCT00586378

NCT00586378已完成3 期

Ovatio DR and VR Implantable Cardioverter Defibrillators Post-approval Study

ELA Medical, Inc.2 个研究点分布在 1 个国家目标入组 85 人开始时间: 2006年4月1日最近更新: 2012年3月2日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: ELA Medical, Inc.
入组人数: 85
试验地点: 2
主要终点: Shock effectiveness for VT/VF

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this post-approval study is to confirm the safety and effectiveness of Ovatio DR and VR ICDs

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Candidates will come from the investigator's general ICD population who meet any of the accepted indications for an ICD implant according to the "ACC/AHA/ESC 2006 Guidelines for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death" (Zipes et al., JACC Vol. 48, No. 5, Sept. 2006:1064-1108).

排除标准

•Ventricular tachyarrhythmia that may have transient or reversible causes such as: acute myocardial infarction, digitalis intoxication, drowning, electrocution, electrolyte imbalance, hypoxia, sepsis, or unstable ischemic episodes
•Incessant tachyarrhythmia
•Implanted pacemaker
•Primary disorder of bradyarrhythmia or atrial tachyarrhythmia
•Of minor age
•Participating in another clinical study

结局指标

主要结局

Shock effectiveness for VT/VF

时间窗: 6 months

The percentage of patients free from complications

时间窗: 6 months

次要结局

未报告次要终点

研究者

发起方

ELA Medical, Inc.

申办方类型

Industry

责任方

Sponsor

研究点 (2)

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