Remote Alert Pathway To Optimize CaRe of Cardiac Implantable Electrical Devices: The RAPTOR-CIED Study (Main Phase)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Major adverse cardiac events
研究概览
简要总结
he 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 Main 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 (Other)
Alert-based care
Alert-based care is an alternative strategy for longitudinal management of patients with wireless pacemakers and implantable defibrillators
干预措施: Alert-based care (Other)
结局指标
主要结局
Major adverse cardiac events
时间窗: 2 years
Incidence of MACE (i.e., death, stroke or systemic embolism, and unplanned cardiac device procedure)
Effectiveness
时间窗: 2 Years
Proportion of total device related encounters that are actionable (e.g., changes in programming or treatment)
次要结局
未报告次要终点
研究者
Daniel B. Kramer
Associate Professor of Medicine
Beth Israel Deaconess Medical Center