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First received: February 03, 2023

Clinical Trial: Interstage Monitoring Using an Implantable Loop Recorder: A Pilot Study

Study Status: NOT_YET_RECRUITING

Recruit Status: NOT_YET_RECRUITING

Condition: Univentricular Heart

Study Type: INTERVENTIONAL


Official Title: Interstage Monitoring Using an Implantable Loop Recorder: A Pilot Study

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…

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