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VitalConnect VitalPatch ECG Interpretation/Arrhythmia Detection

VitalConnect VitalPatch ECG Interpretation/Arrhythmia Detection

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04202718
Enrollment
0
Registered
2019-12-18
Start date
2020-05-15
Completion date
2020-11-30
Last updated
2020-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arrythmia, Cardiac

Keywords

ECG Interpretation

Brief 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.

Interventions

DIAGNOSTIC_TESTVitalPatch 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.

Sponsors

Mercy Research
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Age ≥ 18 years old, * No skin trauma to the site where the patch will be applied * No known allergies to hydrocolloid or silicone based adhesives * Admitted to Mercy Hospital Washington Cardiac Unit on the 5th floor and have been placed in one of the assigned rooms and require cardiac/telemetry monitoring as ordered by their physician

Exclusion criteria

* Pacemaker or Implanted Defibrillator (ICD) * Pregnancy * Adults unable to provide informed consent * Individuals who cannot read and understand English * Prisoners * Not recommended for use in MRI

Design outcomes

Primary

MeasureTime frameDescription
Reduction in false alarms received from current telemetry monitoring technology6 months• Compare generation of false alarms with VitalPatch and current telemetry monitoring

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026