NCT00560768已完成4 期
Predictive Risk Stratification Through T Variability in ICD Patients Without Pacing Indications
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- LivaNova
- 入组人数
- 198
- 试验地点
- 30
- 主要终点
- TAV score and number of tachyarrhythmic events.
研究概览
简要总结
The aim of the study is to assess the negative predictive value of the T amplitude variance as a method for risk stratification for patients with an increased risk for SCD.
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
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has been prescribed the implantation of an SORIN GROUP OvatioTM DR 6550 / VR 6250 system according to relevant currently-approved guidelines
- •CHF since > 3 months and
- •LVEF < 35% and
- •NYHA class II or III
- •Prior Myocardial infarction since more than 4 weeks and
- •LVEF < 30%
排除标准
- •Documented spontaneous sustained ventricular tachycardia
- •Prior implant of any device for ventricular cardiac pacing
- •Existing indication for permanent ventricular pacing
- •Myocardial infarction within 4 weeks prior to enrollment
- •Arrhythmogenic RV-Dysplasia
- •Brugada syndrome
- •Long QT syndrome
- •Performed within 3 months prior to enrollment or scheduled (within 3 months) cardiac revascularization (interventional or surgical)
- •Any indication for CRT accordingly to the relevant currently-approved ACC/AHA1 or ESC35 guidelines for the implantation of a CRT system.
- •Excisting or planned administration of amiodarone - initiation of amiodarone therapy during the run of the study will lead to immediate exclusion of the patient
- •Permanent chronic atrial fibrillation / flutter
- •Patient is unable to attend the scheduled follow-up visits at the participating centre
- •Patient is already included in another ongoing clinical study
- •Patient is unable to understand the objectives of the study
- •Patient refuses to cooperate
- •Patient is unable or refuses to provide informed consent
- •Patient is minor (less than 18-year old)
- •Patient has life expectancy of less than 1 year
- •Patient is pregnant.
研究组 & 干预措施
1
Experimental
干预措施: Ovatio VR 6250 or DR6550 (Device)
结局指标
主要结局
TAV score and number of tachyarrhythmic events.
时间窗: The two phases M0 - M12 and M12 - M24 will be examined separately. For each 12 months period the TAV score at its beginning and tachyarrhythmic events in the following 12 months will be assessed. The NPV will be calculated for both phases.
次要结局
- TAV change(12 months of follow up)
研究者
研究点 (30)
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