Current Environment:


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.


Univentricular Heart

Recruitment Status


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


Intervention Type

Intervention Name




Early Phase 1



Min Age


Max Age

30 Days

Download Date

February 7, 2024

Principal Investigator

This field has been modified from to show a contact specific to Boston Children's.

Primary Contact Information

Olivia Rossi

This field has been modified from to show a contact specific to Boston Children's.

For more information on this trial, visit


For more information and to contact the study team:

Interstage Monitoring Using an Implantable Loop Recorder: A Pilot Study NCT05744934 Olivia Rossi