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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-15

Study Completion Date

2020-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Arrhythmias, Cardiac

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Age 18 years or older;
2. If recommended mobile cardiac telemetry (MCT) by the care provider
3. If instructed, be willing to record information such as daily activities and symptoms
4. Able to speak, read, and write English.

Exclusion Criteria

1. Have extensive skin changes/diseases that preclude wearing the required number of devices on normal skin at the proposed wear sites;
2. Have a known allergy to medical adhesives;
3. Have any potentially life-threatening condition that (for example ventricular tachycardia or ventricular fibrillation), in the opinion of the Investigator, would interfere with their participation in the study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No