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.
Conditions
Univentricular Heart
Recruitment Status
RECRUITING
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
Intervention
Intervention Type
Intervention Name
DEVICE
LUX-Dx™
Phase
EARLY_PHASE1
Gender
ALL
Min Age
N/A
Max Age
30 Days
Download Date
2024-02-07
Principal Investigator
This field has been modified from ClinicalTrials.gov to show a contact specific to Boston Children's.
Primary Contact Information
olivia.rossi@cardio.chboston.org
This field has been modified from ClinicalTrials.gov to show a contact specific to Boston Children's.
For more information on this trial, visit clinicaltrials.gov.
Contact
For more information and to contact the study team: