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

NCT04556240 | Withdrawn FDA Device

• 1 other identifier: TP-323
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Arrhythmias; Real-time Monitoring; Mobile Cardiac Telemetry; VitalPatch; Independent Diagnostic Testing Facility

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

VitalConnect Platform DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of up to five-hundred (500) non-randomized subjects who have been recommended mobile cardiac telemetry by their care provider.

You may qualify if:

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

You may not qualify if:

• Have extensive skin changes/diseases that preclude wearing the required number of devices on normal skin at the proposed wear sites;
• Have a known allergy to medical adhesives;
• 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.

Sponsors & Collaborators

• VitalConnect Inc.: lead

Study Sites (1)

Site 1

Chevy Chase, Maryland, 20815, United States

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dennis Sheehan, MD

  VitalConnect Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2020
• First Posted: September 21, 2020
• Study Start: September 15, 2020
• Primary Completion: October 30, 2020
• Study Completion: November 30, 2020
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)