Pacemaker Remote Electrogram Monitoring Study (PREMS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 571
- 试验地点
- 48
- 主要终点
- Added clinical value of periodic IEGM
研究概览
简要总结
The purpose of the PREMS study is to evaluate the capability of the periodic IEGM feature (intracardiac electrogram) to provide more extensive remote information about cardiac rhythm, sensing and capture, and thus to detect anomalies that may deserve a clinical action.
PREMS is a non-interventional, prospective, and multicenter study. The primary objective is to assess the added clinical value of periodic IEGMs, based on the rate of patients with a rhythm or sensing/pacing anomaly detected on the first IEGM transmitted by Home Monitoring (HM) and non detectable so obvious on the other parameter set offered for the remote follow-up.
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 implanted with a single or dual chamber PM within the last 3 months
- •Home-Monitoring activated and functional
- •Periodic IEGM "ON" and programmed at 30 days intervals
- •Patient willing and able to comply with the protocol and who has provided written informed consent about HM
- •Patient whose medical situation is stable
排除标准
- •Age < 18 years
- •Patient unable to handle the Cardio messenger correctly
- •Participation in another clinical study
结局指标
主要结局
Added clinical value of periodic IEGM
时间窗: 1 month
The main objective of the study is to evaluate the added clinical value of periodic IEGMs for the remote follow-up of PM, compared to other HM data offered by the remote follow-up. Primary endpoint: Rate of patients with at least one rhythm or sensing/pacing anomaly detected on the periodic IEGM, and non detectable on the other HM data. The anomalies are defined as an arrhythmia (extrasystole, atrial fibrillation or flutter), loss of sensing, oversensing or loss of capture.
次要结局
- Added clinical value of the remote follow-up(1 month)
- Planned corrective action(1 month)
- Type of detected anomalies(1 month)
- Capability of periodic IEGM to fulfil the guidelines requirements(1 month)