Interstage Monitoring Using an Implantable Loop Recorder: A Pilot Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Number of patients with successful ILR implantation at the time of surgery
研究概览
简要总结
The primary objective of this investigation is to evaluate the feasibility and safety of implantable loop recorder implantation (using the LUX-DX™) in newborns undergoing stage 1 palliation. The secondary objective of the investigation is to evaluate the feasibility of continuous measurement of heart rate and arrhythmia using an implantable loop recorder (LUX-Dx™) during the interstage period.
An implantable loop recorder will be placed at the time of chest closure following stage 1 palliation (either at the time of index surgery or delayed). The device will be placed in a subclavicular pouch through the existing sternotomy incision. Participants will be in the study for 6 months to 3 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- — 至 30 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with single ventricle physiology undergoing stage 1 palliation in the 1st month of life
排除标准
- •Prematurity (<36 weeks gestational age)
- •Birth weight <2.5 kg
- •Hybrid stage 1 palliation (patent ductus arteriosus stenting, bilateral pulmonary artery bands)
- •Presence and/or need for devices sensitive to magnetic fields such as hearing aids, pacemaker, and other implanted devices.
- •Clinical team does not think that the patient is a good candidate
结局指标
主要结局
Number of patients with successful ILR implantation at the time of surgery
时间窗: At the time of stage 1 surgery, typically the first week of life
Feasibility of ILR implantation
Number of patients with ILR related complication (any of: infection, erosion, device migration, foreign body rejection phenomena, formation of hematomas or seromas, local tissue reaction and/or tissue damage
时间窗: Between the stage 1 and stage 2 surgery, typically until 4-6 months of age
Safety of ILR implantation
次要结局
- Number of patient who completed >70% planned ILR transmissions(Between the stage 1 and stage 2 surgery, typically until 4-6 months of age)
- Number of patients with arrhythmias(Between the stage 1 and stage 2 surgery, typically until 4-6 months of age)
- Complications at the time of ILR removal(At stage 2 or 3 palliation, typically between 4 months and 4 years of age)
- Number of patients with interstage complication(Between the stage 1 and stage 2 surgery, typically until 4-6 months of age)
研究者
Audrey Dionne
Principal Investigator
Boston Children's Hospital