Interstage Monitoring Using an Implantable Loop Recorder: A Pilot Study

Study Overview
=================
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.

Official Title
-----------------
Interstage Monitoring Using an Implantable Loop Recorder: A Pilot Study

Conditions
-----------------
Univentricular Heart

Intervention / Treatment
-----------------
* Device: LUX-Dx™


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Maximum Age: 30 Days

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: LUX-Dx™|Placement of LUX-Dx at the time of stage 1 palliation|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Any arrhythmia, including supraventricular tachycardia, junctional ectopic tachycardia, ventricular tachycardia, atrioventricular block, pause >2.5 seconds | Between the stage 1 and stage 2 surgery, typically until 4-6 months of age | 
| Number of patients with interstage complication | 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 | Between the stage 1 and stage 2 surgery, typically until 4-6 months of age | 
| Complications at the time of ILR removal | Defined as easily removed, removed with difficulty, removed with complication | At stage 2 or 3 palliation, typically between 4 months and 4 years of age |