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

VitalConnect

Status: Withdrawn

Conditions: Arrhythmias, Cardiac

Treatments: Device: VitalConnect Platform

Study type: Observational

Funder types: Industry

Identifiers

NCT04556240

TP-323

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.