Clinical Evaluation to Assess the Effect of the Combination of a Pre-Defined Management Pathway to Reduce Fluid Overload in Cardiac Decompensation With Carelink Remote Management, Connexus Remote Telemetry and the OptiVol Early Warning System on Health Care Utilization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Time to first hospitalization due to worsened heart failure
研究概览
简要总结
This pilot study is to prospectively evaluate the benefit of clinicians being able to access ICD device information in a timelier manner and treat fluid overload with a pre-defined pattern using the Medtronic OptiVol, Medtronic CareAlerts and Medtronic CareLink in Conexus-enabled devices (remote arm) as compared to the same devices without Medtronic OptiVol, Medtronic CareAlerts and Medtronic CareLink available to the treating physician (standard arm).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Implantation of a market-approved Medtronic Connexus CRT-D- or DR-ICD-device
- •Patient consents to study
- •Ability to replace follow-ups with CareLink follow-ups
- •Ability to attend all follow-ups at study center
排除标准
- •Permanent AF
- •Less than 18 years of age
- •Life expectancy less than 15 months
- •Participation in another clinical study
- •Pregnancy
研究组 & 干预措施
2
No Care Alerts available, standard treatment of the patient
1
Remote Arm (OptiVol plus Connexus Telemetry plus CareLink plus Intervention Algorithm), Clinical Management Alerts ON
干预措施: Device triggered remote telephone contact because of Care Alert (Behavioral)
结局指标
主要结局
Time to first hospitalization due to worsened heart failure
时间窗: 15 months
次要结局
- Time from device detected onset of arrhythmias, cardiovascular disease progression and system issues to clinical decision making(15 months)