Actively Recruiting
Interstage Monitoring Using an Implantable Loop Recorder: A Pilot Study
Led by Boston Children's Hospital · Updated on 2024-02-07
10
Participants Needed
1
Research Sites
234 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Interstage Monitoring Using an Implantable Loop Recorder: A Pilot Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with single ventricle physiology undergoing stage 1 palliation in the 1st month of life
You will not qualify if you...
- Prematurity (less than 36 weeks gestational age)
- Birth weight less than 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
A
Audrey Dionne, MD
CONTACT
O
Olivia Rossi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
0
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