Action Elicited By Scheduled In-Hospital Follow-Up of Cardiac Devices
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,362
- 试验地点
- 7
- 主要终点
- Number of Patients of the Whole Population in Whom Something (Therapy, Device Programming ...) Has Been Changed During In-hospital Follow-up
研究概览
简要总结
This study will enroll all patients who will attend an in-hospital follow-up of cardiac device since February 22nd 2010 to June 21st 2010.
Primary objective of the study is to observe how many of patients seen during these period (approximately 5000) will receive a change in cardiac device programming or in drug therapy or a scheduled or urgent hospital admission.
These data should help to clarify how useful and safe is a remote monitoring strategy for this kind of patients.
详细描述
Number of Pacemakers (PM) and Implantable Cardioverter Defibrillators (ICD) is rapidly growing due to enlarged indications. This fact causes an exponential increase in scheduled in-hospital follow-ups. For this reason, all the companies that produce PM and ICD have released systems that allow remote monitoring and follow-up of cardiac devices (both PM and ICD) and U.S. guidelines have already been changed, in order to suggest remote follow-up of these devices at appropriated intervals.
Nevertheless, informations on actions taken during scheduled in-hospital follow-up are incomplete.
ATHENS study has been designed to answer to 3 questions:
- How often, during a scheduled in hospital follow-up physicians "change" something ? (device programming; drug therapy; scheduled device replacement ...)
- The "rate of change" is different is the follow-up is required pby the general practitioner who normally takes care of the patients or by the patient itself?
- Change are more frequent during PM or during ICD follow-up or during cardiac resynchronization therapy devices?
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with a cardiac device
排除标准
- •Follow-up of a cardiac device at discharge from hospital after first implant
结局指标
主要结局
Number of Patients of the Whole Population in Whom Something (Therapy, Device Programming ...) Has Been Changed During In-hospital Follow-up
时间窗: 4 months
次要结局
- Number of Patients -Amongst Those Implanted With a Pacemaker - in Whom Something (Therapy, Device Programming ...) Has Been Changed During In-hospital Follow-up(4 months)
- Number of Patients - Amongst Those Implanted With an Implantable Cardioverter Defibrillator (ICD)- in Whom Something (Therapy, Device Programming ...) Has Been Changed During In-hospital Follow-up(4 months)