Interstage Monitoring Using an Implantable Loop Recorder: A Pilot Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
Study Design
Outcome Measures
Primary Outcome Measures
- 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
- 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
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Boston Children's Hospital | Boston | Massachusetts | United States | 02115 |
Sponsors and Collaborators
- Boston Children's Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB-P00044387