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Interstage Monitoring Using an Implantable Loop Recorder: A Pilot Study
Sponsor: Boston Children's Hospital
Summary
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.
Key Details
Gender
All
Age Range
Any - 30 Days
Study Type
INTERVENTIONAL
Enrollment
10
Start Date
2023-03-15
Completion Date
2027-09-10
Last Updated
2024-02-07
Healthy Volunteers
No
Conditions
Interventions
LUX-Dx™
Placement of LUX-Dx at the time of stage 1 palliation
Locations (1)
Boston Children's Hospital
Boston, Massachusetts, United States