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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
10
Placement of LUX-Dx at the time of stage 1 palliation
Boston Children's Hospital
Boston, Massachusetts, United States
Number of patients with successful ILR implantation at the time of surgery
Feasibility of ILR implantation
Time frame: At the time of stage 1 surgery, typically the first week of life
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
Safety of ILR implantation
Time frame: Between the stage 1 and stage 2 surgery, typically until 4-6 months of age
Number of patient who completed >70% planned ILR transmissions
Time frame: Between the stage 1 and stage 2 surgery, typically until 4-6 months of age
Number of patients with arrhythmias
Any arrhythmia, including supraventricular tachycardia, junctional ectopic tachycardia, ventricular tachycardia, atrioventricular block, pause \>2.5 seconds
Time frame: Between the stage 1 and stage 2 surgery, typically until 4-6 months of age
Number of patients with interstage complication
Any complication, including unplanned emergency department visit, unscheduled hospital admission, unscheduled intensive care unit admission, arrhythmias, major interstage intervention, minor interstage intervention, cardiac arrest, death
Time frame: Between the stage 1 and stage 2 surgery, typically until 4-6 months of age
Complications at the time of ILR removal
Defined as easily removed, removed with difficulty, removed with complication
Time frame: At stage 2 or 3 palliation, typically between 4 months and 4 years of age
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