TRUST: Lumos-T Safely RedUceS RouTine Office Device Follow-up
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,450
- 试验地点
- 215
- 主要终点
- Home Monitoring Effectiveness
研究概览
简要总结
This study is a multi-center, prospective and randomized trial. The primary objective of this study is to demonstrate that the use of the BIOTRONIK Home Monitoring system (HM) can safely reduce the number of regularly scheduled office follow-up visits, compared to the conventional method of implantable cardioverter defibrillator (ICD) follow-up.
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
- •Implanted within the last 45 days or being considered for implant with a BIOTRONIK ICD with Home Monitoring (HM)/Intracardiac Electrogram (IEGM)-Online technology, or legally marketed future generation device with HM/IEGM Online.
- •Able to utilize the HM system throughout the study
- •Ability to give informed consent
- •Geographically stable and able to return for regular follow-ups for fifteen (15) months
- •At least 18 years old
排除标准
- •Patients who do not fulfill all inclusion criteria
- •Pacemaker dependent
- •Currently enrolled in any other cardiac clinical investigation
结局指标
主要结局
Home Monitoring Effectiveness
时间窗: 12 months
Average number of office-based implantable cardioverter defibrillator (ICD) follow-up visits in the Home Monitoring arm vs the Conventional (calendar-based) follow-up arm.
Percent of Participants Experiencing Death, Incidence of Stroke, or Event Requiring Surgical Intervention.
时间窗: 12 months
Percentage of participants experiencing death, incidence of stroke, or event(s) requiring surgical intervention. Outcome measure time frame is 12 months.
次要结局
- Early Detection of Cardiac Events(12 months)
- Patient Initiated Follow-up(12 months)