Interstage Monitoring Using an Implantable Loop Recorder: A Pilot Study

Boston Children's Hospital

Status and phase: Enrolling; Early Phase 1

Conditions: Univentricular Heart

Treatments: Device: LUX-Dx™

Study type: Interventional

Funder types: Other

Identifiers

NCT05744934

IRB-P00044387

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: Under 30 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)