Interstage Monitoring Using an Implantable Loop Recorder: A Pilot Study

NCT05744934 | Completed Early Phase 1 DMC FDA Device

• 1 other identifier: IRB-P00044387
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Univentricular Heart

Outcome Measures

Primary Outcomes (2)

• Number of patients with successful ILR implantation at the time of surgery

  Feasibility of ILR implantation

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

• 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

  Safety of ILR implantation

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

Secondary Outcomes (4)

• Number of patient who completed >70% planned ILR transmissions

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

• Number of patients with arrhythmias

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

• Number of patients with interstage complication

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

• Complications at the time of ILR removal

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

Interventions

LUX-Dx™ DEVICE

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

Eligibility Criteria

• Age: Up to 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients with single ventricle physiology undergoing stage 1 palliation in the 1st month of life

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Univentricular Heart

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 3, 2023
• First Posted: February 27, 2023
• Study Start: March 15, 2023
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)