BIO|MASTER.Cor Family Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 13
- 主要终点
- Cor Family-related Serious Adverse Device Effect (SADE)-Free Rate Until 3-month Follow-up
研究概览
简要总结
Post-Market Clinical Follow-up of the new Cor Family ICDs/CRT-Ds (Acticor, Rivacor) and the new Plexa ProMRI S DX right ventricular lead to provide post-market data and supporting evidence for the clinical safety and performance of the devices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Standard indication for ICD or CRT-D therapy according to clinical guidelines
- •Planned for de novo implantation of an ICD/CRT-D, or upgrade/exchange from existing ICD/CRT-D or pacemaker implant
- •Able to understand the nature of study and to provide written informed consent
- •Willing and able to perform all follow-up visits at the study site
- •Willing and able to use the CardioMessenger and accepts the BIOTRONIK Home Monitoring concept
排除标准
- •Contraindication to ICD and CRT-D therapy
- •Planned for implantation of a CRT-DX system
- •For VR-T DX devices: permanent atrial tachyarrhythmia
- •For VR-T DX devices: patients requiring atrial pacing
- •Less than 18 years old
- •Pregnant or breast feeding
- •Participating in another interventional clinical investigation
- •Life-expectancy is less than 12 months
- •Cardiac surgical procedure planned within 12 months after implantation (including interventional procedures like ablation, valve replacement, heart transplant etc.). Procedures to occur during or prior to implantation are not exclusionary
研究组 & 干预措施
Acticor/Rivacor ICDs/CRT-Ds
Implant of the new Cor Family internal cardioverter defibrillators (ICDs) / Cardiac Resynchronisation Therapy-Defibrillators (CRT-Ds) and Plexa ProMRI S DX lead (if applicable). Device measurements, pre-defined programming and Adverse Event Reporting
干预措施: Acticor/Rivacor ICDs/CRT-Ds (Device)
Acticor/Rivacor ICDs/CRT-Ds
Implant of the new Cor Family internal cardioverter defibrillators (ICDs) / Cardiac Resynchronisation Therapy-Defibrillators (CRT-Ds) and Plexa ProMRI S DX lead (if applicable). Device measurements, pre-defined programming and Adverse Event Reporting
干预措施: Plexa S DX (Device)
结局指标
主要结局
Cor Family-related Serious Adverse Device Effect (SADE)-Free Rate Until 3-month Follow-up
时间窗: 3 months
Serious Adverse Device Effect (SADE)-free rate possibly or securely related to the Cor Family Internal Cardioverter Defibrillators (ICDs) / Cardiac Resynchronisation Therapy-Defibrillators (CRT-Ds) until 3-month follow-up
次要结局
- Kaplan-Meier Estimate for the Cor Family Related SADE-free Rate(3 months, 12 months)
- Number of Handling-Assessments of the Automatic LV VectorOpt Test (CRT-devices Only) by the Investigator(3 months)
- Number of Handling-Assessments for the Overall Handling of the CRT AutoAdapt Feature (CRT-devices Only) by the Investigator(3 months)