Patient Status Engine (PSE): EARLY FEASIBILITY AND USABILITY STUDY

NeuroTherapia, Inc.

Status: Completed

Conditions: Cardiac Arrhythmia

Study type: Observational

Funder types: Other

Identifiers

NCT03480204

17-1656

Details and patient eligibility

About

This study evaluates the feasibility and usability of a wearable patch as a cardiac monitor for non-ICU hospitalized patients.

Full description

This study evaluates the feasibility and usability of a wearable patch cardiac monitor, gateway and server concomitant with standard-of-care cardiac telemetry monitoring for non-ICU hospitalized patients on a selected nursing ward at the Cleveland Clinic Heart and Vascular Institute. All patients will receive routine clinical care on the basis of the traditional telemetry monitoring using the usual processes. The patch monitor data will not be reviewed in real-time, and only analyzed post hoc for agreement with the standard-of-care.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• >= 18 years old and able to provide informed consent
• Standard indication for cardiac telemetry monitoring (institutional standardized criteria) with valid electronic order

Exclusion criteria

• Cardiac implantable device (pacemaker or ICD)
• Contact precautions or isolation
• Telemetry discontinuation planned within 12 hours (i.e. anticipated discharge)