NCT00231426已完成4 期
Arrhythmia Single Shock DFT Versus ULV: Risk Reduction Evaluation With ICDs Study
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
The ASSURE Study will evaluate shock conversion performance when programming the first shock of an implantable cardioverter-defibrillation (ICD) is based on an implant test consisting of either 1) a single induction of ventricular fibrillation (VF) and subsequent demonstration conversion success at 14 J or 2) an upper limit of vulnerability (ULV) test at 14 J.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single
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
- •Patients who meet current indications for an ICD including cardiac resynchronization therapy (CRT) devices
- •Patients who sign and date a Patient Informed Consent form prior to the implant visit
- •Patients who remain in the clinical care of the enrolling physician in approved centers
- •Patients who receive only left-sided pectoral implantations with the ICD lead placed in the right ventricular apex
- •Patients who have a minimum R wave of at least 7 mV; or for ICD replacement, patients who have a minimum chronic R wave of at least 5 mV
排除标准
- •Patients who are involved in Non-Invasive Programming Stimulation (NIPS) studies
- •Patients who undergo lead repositioning
- •Patients who are expected to receive a heart transplant during the duration of the study
- •Patients who have or who are likely to receive a tricuspid valve prosthesis
- •Patients who are currently enrolled in another investigational study or registry that would directly impact the treatment or outcome of the current study
- •Patients who are younger than 18 years of age
- •Patients who are pregnant or plan to become pregnant during the study
- •Patients whose life expectancy is less than 12 months
- •Patients who are mentally incompetent and cannot sign a Patient Informed Consent form or comply with the study
研究者
研究点 (1)
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