Interstage Monitoring Using an Implantable Loop Recorder: A Pilot Study
NCT: NCT05744934 · COMPLETED
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.
Frequently Asked Questions
What is Interstage Monitoring Using an Implantable Loop Recorder: A Pilot Study?
Interstage Monitoring Using an Implantable Loop Recorder: A Pilot Study is a clinical trial registered under NCT05744934. Current status: COMPLETED.
What is the status of NCT05744934?
The current status of NCT05744934 (Interstage Monitoring Using an Implantable Loop Recorder: A Pilot Study) is: COMPLETED.
When did Interstage Monitoring Using an Implantable Loop Recorder: A Pilot Study start?
Interstage Monitoring Using an Implantable Loop Recorder: A Pilot Study started on 2023-03-15.
Official Source
View on ClinicalTrials.gov →Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.