Interstage Monitoring Using an Implantable Loop Recorder: A Pilot Study
Overview
- Phase
- Early Phase 1
- Intervention
- Not specified
- Conditions
- Univentricular Heart
- Sponsor
- Boston Children's Hospital
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Number of patients with successful ILR implantation at the time of surgery
- Status
- Recruiting
- Last Updated
- 2 years ago
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.
Investigators
Audrey Dionne
Principal Investigator
Boston Children's Hospital
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
Outcomes
Primary Outcomes
Number of patients with successful ILR implantation at the time of surgery
Time Frame: 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
Time Frame: Between the stage 1 and stage 2 surgery, typically until 4-6 months of age
Safety of ILR implantation
Secondary Outcomes
- 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)
- Complications at the time of ILR removal(At stage 2 or 3 palliation, typically between 4 months and 4 years of age)
- Number of patients with interstage complication(Between the stage 1 and stage 2 surgery, typically until 4-6 months of age)