Prospective Multicenter Observation Study on the Association Between Remote Monitoring and Clinical Outcome in Heart Failure Patients (Verifying Remote Monitoring Effect on Net Cardiovascular Outcome; RemoteVerify (RêVe))
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 450
- 试验地点
- 2
- 主要终点
- Unplanned early visits for cardiac causes1 (Patient)
研究概览
简要总结
This study investigates the impact and safety of wireless monitoring on the prognosis of heart failure patients with implanted pacemakers and defibrillators. It aims to examine the frequency of unplanned early hospital visits and the early diagnosis/intervention of disease exacerbation based on the presence or absence of wireless monitoring. Additionally, the study analyzes the influence of wireless monitoring on the patient's disease progression as well as satisfaction of the study participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •consented heart failure patients (LVEF<=40%) with Biotronik wireless monitoring capable ICD/CRTs aged >20 years
- •patients who are new to remote monitoring
排除标准
- •For patients with a life expectancy of less than 6 months. If patient do not understand the contents of wireless monitoring or it is difficult to fill out the consent form due to cognitive decline.
- •If wireless monitoring is performed with a patient enrolled in another clinical trial which remote monitoring may affect the previous enrolled study.
结局指标
主要结局
Unplanned early visits for cardiac causes1 (Patient)
时间窗: 6 months
i. Unplanned hospitalization/admission due to patient's condition changes -\> Patients' needs-driven early visits
Unplanned early visits for cardiac causes2 (Patient)
时间窗: 12months
i. Unplanned hospitalization/admission due to patient's condition changes -\> Patients' needs-driven early visits
Unplanned early visits for cardiac causes4 (Clinic)
时间窗: 24months
ii. Hospitalization/Admission due to alerts on the implanted cardiac device following wireless monitoring -\> Clinician-driven early visits
Unplanned early visits for cardiac causes3 (Patient)
时间窗: 18months
i. Unplanned hospitalization/admission due to patient's condition changes -\> Patients' needs-driven early visits
Unplanned early visits for cardiac causes4 (Patient)
时间窗: 24months
i. Unplanned hospitalization/admission due to patient's condition changes -\> Patients' needs-driven early visits
Unplanned early visits for cardiac causes1 (Clinic)
时间窗: 6months
ii. Hospitalization/Admission due to alerts on the implanted cardiac device following wireless monitoring -\> Clinician-driven early visits
Unplanned early visits for cardiac causes2 (Clinic)
时间窗: 12months
ii. Hospitalization/Admission due to alerts on the implanted cardiac device following wireless monitoring -\> Clinician-driven early visits
Unplanned early visits for cardiac causes3 (Clinic)
时间窗: 18months
ii. Hospitalization/Admission due to alerts on the implanted cardiac device following wireless monitoring -\> Clinician-driven early visits
次要结局
- Acute myocardial infarction (heart attack) or cerebrovascular events (stroke)(6,12,18,24 months)
- Thromboembolic events (such as pulmonary embolism)(6,12,18,24 months)
- Worsening of heart failure leading to hospitalization(6,12,18,24 months)
- Cardiac-related deaths(6,12,18,24 months)
- Overall mortality(6,12,18,24 months)