Interstage Monitoring Using an Implantable Loop Recorder: A Pilot Study

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Univentricular Heart

Clinical Trial Details

NCT number	NCT05744934
Study type	Interventional
Source	Boston Children's Hospital
Contact	Audrey Dionne, MD
Phone	617-355-0000
Email	audrey.dionne@cardio.chboston.org
Status	Recruiting
Phase	Early Phase 1
Start date	March 15, 2023
Completion date	September 10, 2027

View Details

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