Univentricular Heart
Conditions
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.
Interventions
DEVICELUX-Dx™
Placement of LUX-Dx at the time of stage 1 palliation
Sponsors
Boston Children's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 30 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
Countries
United States
Outcome results
None listed