Interstage Monitoring Using an Implantable Loop Recorder: A Pilot Study
Trial Parameters
Brief 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 Criteria
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