NCT05744934

Interstage Monitoring Using an Implantable Loop Recorder: A Pilot Study

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Boston Children's Hospital · Academic / Other
• Sex: All
• Age: 30 Days
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	LUX-Dx™	Placement of LUX-Dx at the time of stage 1 palliation

Timeline

• Start date: 2023-03-15
• Primary completion: 2024-09-10
• Completion: 2027-09-10
• First posted: 2023-02-27
• Last updated: 2024-02-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study