NCT04202718

VitalConnect VitalPatch ECG Interpretation/Arrhythmia Detection

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Mercy Research · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Subjects in this study will wear the VitalPatch with the added ECG Interpretation and arrhythmia detection features which will expedite the identification of patients whose condition may rapidly deteriorate as well as eliminate the majority of non-actionable alarms.

Detailed description

This project intends to validate, through comparative study, the output of new technologies (ECG Interpretation and arrhythmia detection) to the VistaCenter platform, aiming to replace current telemetry monitoring equipment. The new technology, through the previous Mercy pilot study, has demonstrated greater accuracy in the detection of ventricular tachycardia patterns and other dysrhythmias/arrhythmias, as well as, reducing the volume of false alarms resulting in the mitigation of alarm fatigue experienced by bedside staff and monitor technicians.

Conditions

• Arrythmia, Cardiac

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	VitalPatch Device	The VitalPatch® is an IRB (791130) and FDA approved wearable device that allows for the constant monitoring of biometric measurements and may have utility in the health management of individuals at high-risk for poor health outcomes and in the detection or prevention of adverse events within settings where more traditional telemetry monitoring devices are not currently in use.

Timeline

• Start date: 2020-05-15
• Primary completion: 2020-11-30
• Completion: 2020-11-30
• First posted: 2019-12-18
• Last updated: 2020-06-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study