MOnitoring REsynchronization deviCes and cARdiac patiEnts
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 918
- 试验地点
- 115
- 主要终点
- Phase 2: Combined Endpoint of Death From Any Cause, Cardiovascular and Device-related Hospitalizations (at Least 48 Hours Stay), Calculated as Number of Subjects With at Least One Event
研究概览
简要总结
The objective of this study is to compare two different strategies of disease management in heart failure patients treated with cardiac resynchronization therapy devices
- Remote monitoring with CareLink Network System
- Standard management of the disease by means of scheduled routine in-patient follow-ups;
and to demonstrate that the remote monitoring strategy is superior to the standard strategy, both in terms of clinical effectiveness and total healthcare system utilization.
详细描述
Major cardiovascular adverse events in patients with heart failure treated with cardiac resynchronization therapy (CRT-D) represent a big concern to the medical community, as they require hospitalizations and may lead to death.
Subjects with a history of heart failure are counseled regarding the importance of contacting their clinicians promptly if they experience any changes or worsening of their condition.
Acute heart failure episodes with hospitalizations represent one of the most relevant causes of health status deterioration for these patients. Moreover, atrial arrhythmias occurrence is a big issue, as it increases the risk of heart failure itself, stroke and inappropriate shocks. In addition to affecting patient health, hospital admission resulting from these complications will impact healthcare costs.
Latest generations of Medtronic CRT-D devices are equipped with a system that triggers an alarm if possible fluid accumulation is detected (OptiVol). This may initiate patient-clinician contact before evident cardiac decompensation. Moreover, advanced diagnostic capabilities for detecting atrial arrhythmias occurrence and total burden are available on such devices.
Importantly, all these devices are now able to inform physician of these events by remote monitoring with CareLink Network parameters, and have the potential of playing a key role in patient monitoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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 indicated to CRT-ICD according to current guidelines:
- •Left ventricular systolic dysfunction (LVEF≤35%),
- •New York Heart Association functional class III-IV,
- •QRS≥120 ms
- •Optimized medical treatment.
- •Patient implanted within the last 8 weeks with Medtronic CRT-ICD device equipped with fluid accumulation diagnostics, AT/AF monitoring capability, wireless telemetry for automatic remote data transmission and alerting system for physician.
- •Patient with less than 8 weeks follow-up, who has not received Carelink® Network Monitor and was not managed by Cardiac Compass report reviewing.
- •Carelink Network is available at patient's home
- •Patient or the patient's caregiver is willing and able to use the Medtronic CareLink® Network Monitor and to perform the required duties at home or has a family member or assistant perform those duties.
- •Patient is willing and able to sign an informed consent form.
排除标准
- •Inability to fully understand the instructions relating to remote monitoring using CareLink® Network.
- •Permanent AT/AF.
- •Patient had not been previously implanted with a CRT/CRT-D device.
- •Patient has medical conditions that would limit study participation.
- •Patient is less than 18 years of age.
- •Patient is enrolled in or intends to participate in another clinical trial that may have an impact on the study endpoints.
- •Patient meets any exclusion criteria required by local law.
- •Inability or refusal to sign a patient informed consent form.
- •Patient's life expectancy is less than one year in the opinion of the physician
- •Patient is pregnant or breastfeeding.
结局指标
主要结局
Phase 2: Combined Endpoint of Death From Any Cause, Cardiovascular and Device-related Hospitalizations (at Least 48 Hours Stay), Calculated as Number of Subjects With at Least One Event
时间窗: 2 years after randomization
Time to first event
Phase 1: Median Time Between Event Onset Time and Clinical Decision for Each Subject.
时间窗: 1 year since the randomization
The median delay from device-detected events to clinical decisions was considerably shorter in the Remote group compared to the Control group
次要结局
未报告次要终点