BIOtronik Study to Assess the CONTINUation of Existing Risk of Ventricular Arrhythmias After CRT-D Replacement for Patients With Primary Prevention Indication
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 289
- 试验地点
- 37
- 主要终点
- Assess the rate of patients with at least one sustained VTA after replacement
研究概览
简要总结
Cardiac resynchronization therapy (CRT) has been shown to reduce heart failure (HF), hospitalizations and death in patients with left ventricular ejection fraction (LVEF) <35% and wide QRS. CRT provides electromechanical resynchronization and improves LV systolic function. The induced LV reverse remodeling or near normalization in LVEF to ≥45% is associated with a significant reduction in the risk of subsequent life-threatening ventricular tachyarrhythmias (VTA). And at the time of replacement, the need for defibrillator back-up after an event-free first CRT-D service-life for patients with improved LVEF is a controversy question.
80% of Implantable Cardioverter Defibrillator (ICD) patients implanted for primary prevention do not experience VTA during the life-time of their first device.
So, regarding patients implanted with a CRT-D for primary prevention at the time of first implantation, the question is will they experience VTA after their device replacement by another CRT-D.
详细描述
The objective of this study is to describe, in a population of patients who had a primary prevention ICD indication at first implantation of a CRT-D, the relevance defibrillator back-up after the replacement of the first CRT-D. For that, the rate of patients with at least one sustained VTA detected by the CRT-D or a conventional surface ECG will be assessed after the device replacement.
Furthermore, the association between the baseline characteristics of the CRT-D population after replacement and the risk of subsequent VTA will be explored after a minimum of two years FU.
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
- •Patient with primary prevention indication for defibrillation at the time of the first CRT-D implantation
- •Patient implanted as first replacement by a CRT-D device (CRT-D by CRT-D)
- •Lifetime of the previous CRT-D > 3 years
- •Patient willing and able to comply with the protocol and who has provided written informed consent
- •Patient whose medical situation is stable.
排除标准
- •Patient with an ICD lead under advisory (e.g. Fidelis lead)
- •Right or left ventricular leads exchange during CRT-D replacement
- •Non functional atrial (except for patient with chronic AF) or right/left ventricular leads
- •Life expectancy < 1 year
- •Age < 18 years
- •Pregnant woman or woman who plan to become pregnant during the trial
- •Participation in another interventional clinical study
结局指标
主要结局
Assess the rate of patients with at least one sustained VTA after replacement
时间窗: up to two years
次要结局
- Rate of patients with at least one VTA for 4 specific subgroups(After the device replacement and after a minimum of two years follow-up (FU))