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Comparative Study of the Sternal Patch System With a Conventional Holter Recorder

NCT04241692 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-07-28

No results posted yet for this study

Summary

This study will be a comparison of two externally worn recording systems for documentation of cardiac arrhythmias in symptomatic patients or patients at risk for arrhythmia. Non-invasive documentation of cardiac arrhythmias can be done using the standard electrocardiogram (ECG). This has limitations given it is performed for only a 10 sec period. Alternative methods for making longer term recording have been developed. The standard device is the 24 hour 7-lead Holter monitor. Newer technology has simplified the hardware needed to make these longer term recordings, and incorporate a self-contained recording system in a patch that is applied over the patient's chest. Little is known comparing the sensitivity, specificity and recording noise / signal artifact between the older technology (standard 24-Hour Holter monitor) and the Patch electrode.

Conditions

  • Cardiac Arrhythmia
  • Syncope

Interventions

DEVICE

CarnationTM Ambulatory Monitoring Sternal ECG Patch System

A newly developed cardiac rhythm monitoring system

DEVICE

Conventional 24-Hour 7 Lead Holter Monitor Recorder

Traditional recordings made using a standard 24-hour Holter monitor.

Sponsors & Collaborators

  • Children's National Research Institute

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-19
Primary Completion
2023-02-01
Completion
2023-03-01
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 NCT04241692 on ClinicalTrials.gov