CLINICAL EVALUATION OF REMOTE MONITORING WITH DIRECT ALERTS TO REDUCE TIME FROM EVENT TO CLINICAL DECISION. (REACT Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- time between the detection of an event and the point in time when the physician or delegate takes a clinical decision
研究概览
简要总结
St. Jude Medical developed the Merlin.net™ Patient Care Network (Merlin.net™ PCN) to augment or replace routine scheduled in-clinic visits.
This investigation is designed with the hypothesis that detection of events (system integrity and diagnostic related) through Direct Alerts™ via Remote Monitoring allow clinicians an earlier opportunity to address and resolve events and may therefore improve patient care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
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
- •The patient meets ACC/AHA/ESC guidelines for implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT-D) device
- •The patient is recently (≤2 weeks) implanted with a SJM device compatible with the Merlin.net™ PCN - (inclusive of upgrade from ICD to CRT-D or an implantable pulse generator change)
- •The patient has a life expectancy of greater than 12 months (based on the physician's discretion).
- •The patient is mentally capable to participate in the investigation (based on the physician's discretion).
- •The patient is 18 years of age or older
排除标准
- •The patient is being actively considered for cardiac transplantation.
- •The patient has primary valvular disease that has not been corrected.
- •The patient had a myocardial infarction within the last month
- •The patient had unstable angina within the last month.
- •The patient has had Coronary Artery Bypass Grafting (CABG) within the last month.
- •The patient had a Percutaneous Coronary Angioplasty (PTCA) within the last month.
- •The patient is pregnant.
研究组 & 干预措施
Direct Alerts ON
Direct Alerts in implantable device were turned on
干预措施: Implantation of an ICD/CRT-D device (Device)
Direct Alerts ON
Direct Alerts in implantable device were turned on
干预措施: Merlin.NET PCN (Device)
Direct Alerts OFF
Direct Alerts in implantable device were turned off
干预措施: Implantation of an ICD/CRT-D device (Device)
Direct Alerts OFF
Direct Alerts in implantable device were turned off
干预措施: Merlin.NET PCN (Device)
结局指标
主要结局
time between the detection of an event and the point in time when the physician or delegate takes a clinical decision
时间窗: 2 years
次要结局
- The sufficiency of the device data retrieved through the Remote Monitoring feature to make a clinical decision(2 years)
- The physician or delegate time required for remote follow up as compared to in-clinic follow up(2 years)
- The changes over one year in the Hospital Anxiety and Depression Scale (HADS) for the two different randomization arms(2 years)