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RECORD-VP: Real-time Evaluation of Cardiac Outpatient Recording Device With VitalPatch RTM

NCT04556240 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2023-07-27

No results posted yet for this study

Summary

The primary purpose of this study is to evaluate performance and safety of the VitalConnect Platform when used for mobile cardiac telemetry (MCT) or as an independent diagnostic testing facility (IDTF) system during activities of daily living by subjects 18 years or older who have been recommended MCT by their care provider.

Conditions

  • Arrhythmias, Cardiac

Interventions

DEVICE

VitalConnect Platform

The VitalConnect Platform is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological and irregular heart rhythm data in home and healthcare settings. This includes heart rate, electrocardiogram (ECG), heart rate variability (R-R interval), breathing rate, arrhythmia detection, body temperature, skin temperature, activity (including step count), and posture (body position relative to gravity including fall). Data is transmitted wirelessly to a central location where it is stored for analysis. The VitalConnect Platform can be configured by authorized persons to notify healthcare professionals when physiological data falls outside selected parameters

Sponsors & Collaborators

  • VitalConnect Inc.

    lead INDUSTRY

Principal Investigators

  • Dennis Sheehan, MD · VitalConnect Inc.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-15
Primary Completion
2020-10-30
Completion
2020-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04556240 on ClinicalTrials.gov