VitalConnect VitalPatch ECG Interpretation/Arrhythmia Detection

NCT04202718 | Withdrawn FDA Device

• 1 other identifier: 20-007
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Arrythmia, Cardiac

Keywords

ECG Interpretation

Outcome Measures

Primary Outcomes (1)

• Reduction in false alarms received from current telemetry monitoring technology

  • Compare generation of false alarms with VitalPatch and current telemetry monitoring

  6 months

Study Arms (1)

Single group

OTHER

Where a wearable biosensor is being considered for use 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 traditional monitoring devices are not currently in use, the ECG interpretation will provide Arrhythmia detection which will help ensure that irregular rhythms will be reported quickly.

Diagnostic Test: VitalPatch Device

Interventions

VitalPatch Device DIAGNOSTIC_TEST

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.

Single group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mercy Research: lead

Study Sites (1)

Mercy Hospital Washington

Washington, Missouri, 63090, United States

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: December 16, 2019
• First Posted: December 18, 2019
• Study Start: May 15, 2020
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: June 24, 2020

Record last verified: 2020-06

Locations

US (1)