Interstage Monitoring Using an Implantable Loop Recorder: A Pilot Study
Boston Children's Hospital
10 participants
Mar 15, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria1
- Patients with single ventricle physiology undergoing stage 1 palliation in the 1st month of life
Exclusion Criteria5
- 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
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Interventions
Placement of LUX-Dx at the time of stage 1 palliation
Locations(1)
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NCT05744934