VitalConnect VitalPatch ECG Interpretation/Arrhythmia Detection

Arrythmia, Cardiac Clinical Trial

Official title:

VitalConnect VitalPatch ECG Interpretation/Arrhythmia Detection

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04202718
• Other study ID #: 20-007
• Status: Withdrawn
• Phase: N/A
• Start date: May 15, 2020
• Est. completion date: November 30, 2020

Study information

• Verified date: June 2020
• Source: Mercy Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Arrythmia, Cardiac

Intervention

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.

Locations

Country	Name	City	State
United States	Mercy Hospital Washington	Washington	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Mercy Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in false alarms received from current telemetry monitoring technology	• Compare generation of false alarms with VitalPatch and current telemetry monitoring	6 months