Evaluation of a Proactive Clinical Management and Early Diagnosis of Arrhythmias in Patients With Heart Failure and Non Severely Reduced Left Ventricular Function Through a Telemonitoring System: a Prospective Randomized Clinical Trial (VASCO)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 331
- 主要终点
- Evaluate the benefits of a remote monitoring management based on ILR vs standard practice in patients with high risk of cardiac arrhythmias, heart failure and LVEF> 40% in the detection of significant clinical events.
研究概览
简要总结
Vasco trial is a no profit, multicenter, international, prospective, randomized study designed to evaluate the clinical benefits of a remote monitoring management based on ILR vs standard practice in patients with high risk of cardiac arrhythmias, heart failure and left ventricle ejection fraction (LVEF)> 40% .The study will enroll about 331 patients (221 in the ILR group and 110 in the in-hospital follow-up group).
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
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with heart failure, LVEF> 40% who report episodes of palpitations.
- •Over 18 years of age
- •Ability to provide informed consent for registry participation and be willing and able to comply with the protocol described evaluations
排除标准
- •Subject who is, or is expected to be unavailable for follow-up
- •Pregnancy
- •Medical contraindications for ILR implantation
- •Patients with PMK / ICD or with Indication for ICD / PMK implantation
- •Cardiovascular events / myocardial revascularization in the previous three months
- •Patients already on oral anticoagulant treatment
- •Patients who do not want to use the telemonitoring system
- •Presence of other recognized indications to ILR (Unexplained syncope, cryptogenic stroke/TIA, Transient loss of consciousness and recurrent falls)
结局指标
主要结局
Evaluate the benefits of a remote monitoring management based on ILR vs standard practice in patients with high risk of cardiac arrhythmias, heart failure and LVEF> 40% in the detection of significant clinical events.
时间窗: 2 years
Detection rate of arrhythmias that require treatment (medical or interventional)
次要结局
未报告次要终点
研究者
Leonardo Calò, MD
Principal Investigator
Policlinico Casilino ASL RMB