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临床试验/NCT07352657
NCT07352657尚未招募不适用

Remote Alert Pathway To Optimize CaRe of Cardiac Implantable Electrical Devices: The RAPTOR-CIED Study (Main Phase)

Beth Israel Deaconess Medical Center1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2026年12月1日最近更新:
干预措施

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

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

Active Comparator

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

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniel B. Kramer

Associate Professor of Medicine

Beth Israel Deaconess Medical Center

研究点 (1)

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