Reduction of Inappropriate Shocks of Implantable Cardioverter Defibrillators (ICDs) With Enhanced SVT Discriminators
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 735
- 试验地点
- 30
- 主要终点
- Inappropriate ICD shocks
研究概览
简要总结
The purpose of this clinical investigation is the continued assessment of the decision accuracy of St. Jude Medical (SJM) ICD with enhanced SVT discriminators in the treatment of subjects with primary and secondary prevention of sudden cardiac death.
详细描述
With Ellipse™ and Fortify Assura™ ICD family, St. Jude Medical introduced enhanced device algorithms that may be helpful to further improve SVT discrimination success: SecureSense™, Far field morphology, Chamber Onset. These algorithms in combination with a tailored device setting (primary or secondary prevention) will be prospectively investigated within this trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Ischemic or nonischemic cardiomyopathy
- •Primary prevention or secondary prevention of Sudden cardiac death (SCD)
- •Indication for ICD/CRT-D new implantation per current guidelines (1, 2, 3-chamber)
- •The patient is ≥ 18 years of age
- •The patient is able to understand the patient information and is capable to provide informed consent.
- •The patient has provided written informed consent prior to any investigational related procedure
排除标准
- •Previously implanted ICD/CRT-D
- •Hypertrophic (with or without obstructive) cardiomyopathy
- •Ion channel disorders (Long/Short-QT, Brugada syndrome etc...)
- •New York Heart Association (NYHA) Class IV
- •Recent cardiac decompensation (within previous 3 months)
- •The patient is unable to comply with the follow up schedule.
- •The patient is participating in another investigational device or drug investigation.
- •The patient is pregnant or is planning to become pregnant during the duration of the investigation
研究组 & 干预措施
Enhanced SVT discriminators
Patients with activated enhanced SVT discriminators (in accordance with predefined mandatory study settings)
干预措施: ICD with enhanced SVT discriminators (Device)
结局指标
主要结局
Inappropriate ICD shocks
时间窗: 12 months
Freedom from inappropriate automatically delivered ICD-shocks within 12 months Follow-Up (FU) period after ICD/CRT-D implantation
次要结局
- Cardiac deaths(12 months)
- ICD/CRT-D related SAE(12 months)
- ICD shocks for any reason(12 months)
- Inappropriate ICD therapies(12 months)
- Untreated VT/VF(12 months)
- Specificity(12 months)
- Sensitivity(12 months)
- Accuracy of ICD therapy decision(12 months)