Overview
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 Criteria:
- Patients with single ventricle physiology undergoing stage 1 palliation in the 1st month of life
Exclusion Criteria:
- 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
