Wrist Worn Blood Pressure Measurement

• Conditions: Advanced Heart Failure; Blood Pressure; Heart Failure; Heart Failure，Congestive
• Interventions: Device: Wrist-worn measurement device (LiveMetric)

• Registration Number: NCT03919136
• Lead Sponsor: LiveMetric S.A.

Brief Summary

In this study, the investigators are testing the accuracy of a wrist-worn measurement device by comparing its blood pressure measurement to arterial line (A-line) blood pressure monitors. The device is similar in style and fit to popular activity bands, but it is unique in that it measures blood pressure.

Detailed Description

LiveMetric has developed a wrist-worn measurement device intended for use as a standalone device, designed for measurement of intermittent blood pressure for individuals suffering from hypertension or other conditions where monitoring of blood pressure is of importance.

The wrist-worn measurement device is intended to be worn on the wrist for intermittent measurements of Blood pressure.

The use does not require any special action from the user apart from wearing the band on either their left or right wrist. The device applies no inflatable mechanics or moving parts. The wristband is watertight and can be worn as any type of bracelet all the time or most of the time.

The study will include subjects that are hospitalized in the ICU and/or any of the cardiology departments or affiliating units such as Cath lab, heart transplant unit, etc..) and are continually monitored by an intra-arterial blood pressure line (A-line). A medical professional will measure simultaneous non-invasive auscultatory readings to determine the lateral difference for later adjustment of calculation. A medical professional or a company representative accompanied by a medical professional will place the device on the opposite limb than the one having the A-line, providing the location of the placement has intact skin. During the measurement stage, BP values are simultaneously recorded from the reference invasive A-line and the wrist worn device.

Study Timeline

• Study Start: 2018-08-01
• Status Verified: 2019-04
• Study First Submitted: 2019-04-15
• Study First Submitted QC: 2019-04-15
• Last Update Submitted: 2019-04-17
• Study First Posted: 2019-04-18
• Last Update Posted: 2019-04-19
• Primary Completion: 2019-10-01
• Study Completion: 2019-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients who have a pre-existing intra-arterial blood pressure (A-Line) line for standard care
• Patients that are ≥18 years of age.

Exclusion Criteria

• Body habitus that precludes patients from wearing a device on their wrist
• Subjects without normal palpable radial artery pulse, whether congenital, due to medical intervention, or otherwise
• Subjects with wrist circumference less than 155mm or greater than 210mm
• Subjects implanted with pacemaker, VAD's or other mechanical circulatory support device whether intracorporeal or extracorporeal
• Patients that do not have an intra-arterial blood pressure line.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Primary Objective	Wrist-worn measurement device (LiveMetric)	Evaluation of the devices accuracy referenced to interventional (A-line) measurement.

Primary Outcome Measures

Name	Time	Method
Non-Oscillometric Blood Pressure Wrist Worn Data Acquisition and Analysis	2 years	Measurements including systolic and diastolic pressures will be assessed and analyzed retrospectively according to the requirements of the standard (ISO 81060-2).

Trial Locations

Locations (3)

NYU School of Medicine; 🇺🇸 New York, New York, United States

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States