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

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.

Study Overview

• Status: Withdrawn
• Conditions: Arrhythmias, Cardiac
• Intervention / Treatment: Device: VitalConnect Platform

• Study Type: Observational

Contacts and Locations

• Study Contact: Name: Olivier Colliou; Phone Number: (408) 963-4600; Email: ocolliou@vitalconnect.com
• Study Contact Backup: Name: Anagha Desai

Study Locations

• United States
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • Site 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: VitalConnect Inc.
• Investigators: Principal Investigator: Dennis Sheehan, MD, VitalConnect Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): September 15, 2020
• Primary Completion (Estimated): October 30, 2020
• Study Completion (Estimated): November 30, 2020

Study Registration Dates

• First Submitted: September 2, 2020
• First Submitted That Met QC Criteria: September 14, 2020
• First Posted (Actual): September 21, 2020

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 25, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Arrhythmias; Real-time Monitoring; Mobile Cardiac Telemetry; VitalPatch; Independent Diagnostic Testing Facility
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: TP-323

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes