Management and Detection of Atrial Tachyarrhythmias in Patients Implanted With BIOTRONIK DX Systems
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,054
- 试验地点
- 1
- 主要终点
- Frequency and types of AF-related complications
研究概览
简要总结
This is an observational registry study aiming to collect data on efficacy and safety of the single chamber Biotronik DX system with enhanced atrial diagnostics. The minimal follow-up period is 24 months. All analyses on the data will be done post-hoc; the study does not intend to confirm any pre-specified hypotheses.
详细描述
Enrollment (E0)
Timing:
• The enrollment (date of patient written informed consent) starts after implantation of a BIOTRONIK Lumax 540 VR-T DX ICD with Linoxsmart S DX or successor single chamber DX system according to current guidelines (primary or secondary prevention) but should not be later than 90 days after implantation.
Procedures:
- Check inclusion and exclusion criteria
- Patient information and written informed consent process
- Assignment of a unique study code
- ICD interrogation (re-programming if necessary)
- HMSC registration (recommended)
- Investigator assessment: appropriate atrial sensing
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Indication for implantation of a single chamber ICD (primary or secondary prevention) according to current guidelines
- •Implanted with a BIOTRONIK Lumax 540 VR-T DX ICD with Linoxsmart S DX or successor single chamber DX system within 90 days prior to enrollment
- •Written informed consent, willingness and ability to comply with the protocol
排除标准
- •Age < 18 years
- •Any limitation to contractual capability
- •Female patients who are pregnant or breast feeding or plan a pregnancy during the course of the study
- •Known active malignant disease or recovered from malignant disease within 2 years prior to enrollment
- •Simultaneous participation in another study
- •Life expectancy < 2 years
结局指标
主要结局
Frequency and types of AF-related complications
时间窗: 24 months
Time to occurrence of first AF-related complication
时间窗: 24 months
Time to AF-related intervention after detection of de novo or worsening AF
时间窗: 24 months
次要结局
- All-cause mortality(24 months)
- Frequency and type of complications related to implantation(24 months)
- Significance of AF in acute decompensation of heart failure(24 months)
- Interventions based on Home Monitoring information regarding AF(24 months)
- Cardiovascular hospitalization with days in hospital(24 months)
- Frequency and type of lead-related complications(24 months)