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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04556240
Other study ID # TP-323
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date September 15, 2020
Est. completion date November 30, 2020

Study information

Verified date July 2023
Source VitalConnect Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date November 30, 2020
Est. primary completion date October 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Site 1 Chevy Chase Maryland

Sponsors (1)

Lead Sponsor Collaborator
VitalConnect Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Successfully detect heart rhythm of the study subjects using VitalConnect platform as a mobile cardiac telemetry unit Monitor the heart rhythm of the study subjects initially for up to 24 hours and if the monitoring finds the issue that the doctor is looking for, the monitoring will be stopped. In most of the cases, the monitoring can continue for up to 30 days for each study subject Each patient will be monitored for up-to 30 days
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