Interstage Monitoring Using an Implantable Loop Recorder: A Pilot Study

Launched by BOSTON CHILDREN'S HOSPITAL · Feb 15, 2023

Keywords

ClinConnect Summary

This clinical trial, called "Interstage Monitoring Using an Implantable Loop Recorder: A Pilot Study," is looking at a new device called the LUX-DX™ that helps monitor the heart in newborns with a specific heart condition called univentricular heart. The main goal of the study is to see if it's safe and feasible to implant this device during a surgery known as stage 1 palliation. The device will help doctors continuously check the baby’s heart rate and look for any irregular heartbeats (arrhythmias) during a critical recovery period that can last from 6 months to 3 years.

To be eligible for this trial, babies must be less than one month old and have a single ventricle heart condition. Unfortunately, babies who were born prematurely, weighed less than 2.5 kg at birth, or have certain other heart treatments or devices may not qualify. If a baby does join the study, the device will be placed under the skin during their surgery, and the family can expect regular check-ups to monitor the baby’s heart health. This study is currently recruiting participants, and it aims to gather important information that could help improve care for these infants in the future.

Gender

ALL

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