Interstage Monitoring Using an Implantable Loop Recorder: A Pilot Study

Early Phase 1

Recruiting

• Conditions: Univentricular Heart

• Registration Number: NCT05744934
• Lead Sponsor: Boston Children's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-03
• Study First Submitted QC: 2023-02-15
• Study First Posted: 2023-02-27
• Study Start: 2023-03-15
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-07
• Primary Completion: 2024-09-10
• Study Completion: 2027-09-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of patients with successful ILR implantation at the time of surgery	At the time of stage 1 surgery, typically the first week of life	Feasibility of ILR implantation
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	Between the stage 1 and stage 2 surgery, typically until 4-6 months of age	Safety of ILR implantation

Secondary Outcome Measures

Name	Time	Method
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	Any arrhythmia, including supraventricular tachycardia, junctional ectopic tachycardia, ventricular tachycardia, atrioventricular block, pause \>2.5 seconds
Complications at the time of ILR removal	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
Number of patients with interstage complication	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

Trial Locations

Locations (1)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States