Reduction of Inappropriate ICD Therapies in Patients With Approved Indication for Primary Prevention of Sudden Cardiac Death
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 543
- 试验地点
- 68
- 主要终点
- Primary Endpoint
研究概览
简要总结
The purpose of this study is to determine efficacy of a dedicated programming concept for avoidance of inappropriate implantable cardioverter defibrillator (ICD) therapies in patient with primary prevention ICD indication.
详细描述
Inappropriate ICD therapies still remains a major issue with respect to patient's quality of life and proarrhythmic risk.
It's the aim of this study to determine efficacy of a dedicated programming concept for avoidance of inappropriate ICD therapy in patients who received the ICD for primary prevention of sudden cardiac death.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Approved indication for new ICD implantation for primary prevention of sudden cardiac death
- •Age >=18 Years
- •Written informed consent
排除标准
- •ICD indication for secondary prevention reasons
- •ICD indication for "electrical" disorders (i.e. long/short QT syndrome, Brugada syndrome etc...)
- •ICD change or upgrade
- •Pregnancy
- •Patient is already participating to another study with active therapy arm
- •Patient will most likely not be able to participate to the routine follow ups in the study center.
研究组 & 干预措施
Group A
Group A:
- VT zone: 350ms
- VF zone: 280ms
干预措施: device settings for group A (Device)
Group B
Group B:
- VT zone: 320ms
- VF zone: 250ms
干预措施: Device settings for group B (Device)
结局指标
主要结局
Primary Endpoint
时间窗: 12 months
Event free survival of: 1. inappropriate ICD therapies (only stored tachycardias with proper stored EGM documentation are taken into account) AND 2. spontaneous, documented, sustained (\>30s) ventricular tachycardia, that was not treated by the ICD
次要结局
- Amount of patients with appropriate / inappropriate ICD therapies(12 months)
- Specificity for SVT diagnosis(12 months)
- Cardiac mortality(12 months)
- Prevalence of slow VT (<=187bpm) in patients with indication for primary prevention of SCD(12 months)
- Time to first appropriate / inappropriate ICD therapy(12 months)
- Amount of patients with appropriate / inappropriate shocks or ATP(12 months)
- Number and cycle lengths of supraventricular / ventricular tachys(12 months)
- Sensitivity for diagnosis of sustained VT(12 months)
- Quality of Life (MLHF Questionaire)(12 months)
- Overall mortality(12 months)
- Frequency and efficacy of ATP prior to / before capacitor charging in VF zone(12 months)