Cohorte Française Des Patients Implantés de Micra AV
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Profile of patients implanted with Micra AV
研究概览
简要总结
Transvenous cardiac pacemakers have pitfalls due to lead- and device pocket-related complications. Leadless pacemakers were developed and introduced into clinical practice to overcome the weaknesses of traditional transvenous pacemakers. The absence of atrial pacing has restricted their uses mainly for cases of paroxysmal atrioventricular block (AVB) or AVB with atrial fibrillation. The Micra AV contains an embedded accelerometer that senses the atrial contraction waveform, allowing the ventricle to be paced once the atrial contraction is complete. This atrioventricular synchronization is intended to extend the use of the device to cases of permanent complete AVB with normal sinus function. Two randomized clinicals trials have been proven it's efficacy. However, with AV-CESAR cohort, we aim to evaluate the real word effectiveness of Micra AV, in the first 1000 patients implanted by the device in France.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients who underwent Micra AV implantation
排除标准
- •Refusal of consent
结局指标
主要结局
Profile of patients implanted with Micra AV
时间窗: Through study completion, an average of 3 years
Description of the population of patients implanted by the device : age, sex, comorbidities (rate of hypertension, diabetes, ischemic heart disease, heart failure, severe pulmonary disease, severe chronic renal failure, cirrhosis, severe impairement of mobility, severe psychiatric disease or demencia and TAVR)
Follow-up occurrence of upgrading to a dual-chamber pacemaker
时间窗: Through study completion, an average of 3 years
Rate of pacemaker syndrome and requirement of dual-chamber pacemaker upgrade
Early and late device-related complications
时间窗: Through study completion, an average of 3 years
Rate of inhospital and late complications related to Micra AV
次要结局
- Risk factors of a compromised quality of life(Through study completion, an average of 3 years)
- Assessment of the quality of life in permanent atrioventricular block and normal sinus function subgroup(Through study completion, an average of 3 years)