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

Arrhythmias, Cardiac Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04556240
• Other study ID #: TP-323
• Status: Withdrawn
• 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
• 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• Status: Withdrawn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.

Related Conditions & MeSH terms

• Arrhythmias, Cardiac

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