Remote Alert Pathway To Optimize CaRe of Cardiac Implantable Electrical Devices
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Enrollment
研究概览
简要总结
The Remote Alert Pathway to Optimize Care of Cardiac Implantable Electrical Devices (RAPTOR-CIED) Study is a pragmatic, multi-center, randomized trial with 1:1 patient-level randomization comparing the safety and effectiveness of alert-driven care versus guideline-based care for patients with wireless cardiac implantable electrical devices (CIEDs).
The study will be conducted in 2 phases: a Feasibility Phase and a Main Phase. This registration outlines the goals and design features of the Feasibility Phase of the study.
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
- Single (Outcomes Assessor)
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
- •Adult aged > 18 years
- •Clinically stable by investigator assessment
- •Has a newly implanted or existing wireless CIED: single, dual-chamber, biventricular, subcutaneous/extravascular, and leadless systems are all eligible, including pacemakers or implantable cardioverter-defibrillators (ICDs)
- •CIED is from one of the 4 major CIED manufacturers in the US market (99% of implants in the US): Medtronic, Boston Scientific, Abbott, Biotronik
- •Currently enrolled in remote monitoring as part of standard of care
- •Primary clinical electrophysiology follow-up at the enrolling center
- •Understands spoken and written English, Spanish, or Portuguese
- •Has sufficient cognitive function to answer standardized questions about study rationale and procedures.
排除标准
- •Presence of insertable cardiac monitor, either in isolation or in combination with any other CIED
- •Listed for cardiac transplantation prior to enrollment (N.B. if a patient becomes listed for transplantation during the study, they may continue study participation)
- •Participation in another study related to novel CIED technology or remote monitoring.
研究组 & 干预措施
Guideline-based Care
Remote monitoring programming scheduled for alert transmissions, patient-initiated transmissions, and routine transmissions (scheduled to occur every 90 days from the date of enrollment in the study); in-office interrogations on at least an annual basis
干预措施: Guideline-based care (Device)
Alert-based Care
Remote monitoring programming scheduled for alert transmissions and patient-initiated transmissions only
干预措施: Alert-based care (Device)
结局指标
主要结局
Enrollment
时间窗: 6 months
Number of patients enrolled and randomized per site and per month, and cumulatively
Adherence
时间窗: 6 months
Proportion of cross-over
次要结局
- Connectivity(6 months)
- Major adverse cardiac events(6 months)
- Effectiveness(6 months)
- Quality of Life and Health Status(Baseline, 3 months, and 6 months)
研究者
Daniel B. Kramer
Associate Professor of Medicine
Beth Israel Deaconess Medical Center