Master Study of the Evia/Entovis HF-T Pacemaker
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Safety: Serious Adverse Device Effect (SADE) free rate
研究概览
简要总结
The Evia HF-T and the Entovis HF-T are triple-chamber pacemakers for cardiac resynchronisation therapy (CRT-P). The objective of this study is to prove the safety and efficacy of these pacemakers. In particular, the left ventricular (LV) capture control feature is evaluated, which automatically measures the LV pacing threshold and subsequently adjusts the pacing output.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Standard indication for CRT therapy
- •Legal capacity and ability to consent
- •Signed patient informed consent
排除标准
- •Contraindication for CRT therapy
- •ICD indication
- •Age < 18 years
- •Pregnant or breast-feeding woman
- •Cardiac surgery planned within the next 6 months
- •Life expectancy of less than 6 months
- •Participating in another clinical study of an investigational cardiac drug or device
结局指标
主要结局
Safety: Serious Adverse Device Effect (SADE) free rate
时间窗: Until 3 month follow-up
While the investigator is asked to record all adverse events throughout the study, only the number of SADEs possibly or securely related to a device deficiency will be the basis for the calculation of the SADE free rate: (1-number of SADE divided by number of patients)%.
Efficacy of the left ventricular capture control feature (focus on threshold measurements)
时间窗: At pre-hospital discharge, 1 and 3 month follow-up
Absolute difference between the triggered automatic and manual pacing threshold in the left ventricle is smaller than 0.3 Volt.
次要结局
- Efficacy of the left ventricular capture control feature (focus on pulse amplitude adjustment)(1 and 3 month follow-up)