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Completed

NCT Number: NCT05744934

Interstage Monitoring Using an Implantable Loop Recorder: A Pilot Study

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.

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Key information

Conditions

Univentricular Heart Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

Up to 30 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LUX-Dx™

Device

Placement of LUX-Dx at the time of stage 1 palliation

Primary outcomes

  1. Number of patients with successful ILR implantation at the time of surgery

    Time frame: At the time of stage 1 surgery, typically the first week of life

    Feasibility of ILR implantation

  2. Number of patients with ILR related complication (any of: infection, erosion, device migration, foreign body rejection phenomena, formation of hematomas or seromas, local tissue reaction and/or tissue damage

    Time frame: Between the stage 1 and stage 2 surgery, typically until 4-6 months of age

    Safety of ILR implantation

Secondary outcomes

  1. Number of patient who completed >70% planned ILR transmissions

    Time frame: Between the stage 1 and stage 2 surgery, typically until 4-6 months of age

  2. Number of patients with arrhythmias

    Time frame: Between the stage 1 and stage 2 surgery, typically until 4-6 months of age

    Any arrhythmia, including supraventricular tachycardia, junctional ectopic tachycardia, ventricular tachycardia, atrioventricular block, pause >2.5 seconds

  3. Number of patients with interstage complication

    Time frame: Between the stage 1 and stage 2 surgery, typically until 4-6 months of age

    Any complication, including unplanned emergency department visit, unscheduled hospital admission, unscheduled intensive care unit admission, arrhythmias, major interstage intervention, minor interstage intervention, cardiac arrest, death

  4. Complications at the time of ILR removal

    Time frame: At stage 2 or 3 palliation, typically between 4 months and 4 years of age

    Defined as easily removed, removed with difficulty, removed with complication

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 27, 2023
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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