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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LUX-Dx™ | Device | Placement of LUX-Dx at the time of stage 1 palliation |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
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| ID | Term |
|---|---|
| D000080039 | Univentricular Heart |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
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| 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 |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |