Recruiting

Observational Study

Sponsor:

LiveMetric S.A.

Code:

NCT03919136

Conditions

Blood Pressure

Heart Failure

Advanced Heart Failure

Heart Failure，Congestive

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Wrist-worn measurement device (LiveMetric)

Study Details

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.

Conditions

Blood Pressure

Heart Failure

Advanced Heart Failure

Heart Failure，Congestive

Study ID

NCT03919136

Start date

Aug 1, 2018

Status verified date

Apr, 2019

Completion date

Oct 1, 2019

Anticipated

Primary completion date

Oct 1, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

Primary Objective

Evaluation of the devices accuracy referenced to interventional (A-line) measurement.

Interventions

Wrist-worn measurement device (LiveMetric)

Evaluation of the wrist-worn measurement devices accuracy referenced to interventional (A-line) measurements.

Primary outcome measure

  • Non-Oscillometric Blood Pressure Wrist Worn Data Acquisition and Analysis [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Gabriel Sayer, MD

773-702-9396gsayer@medicine.bsd.uchicago.edu

Daniel E Rodgers

773-702-9396drodgers3@medicine.bsd.uchicago.edu

Locations

University of Chicago

Recruiting

Chicago, Illinois, United States, 606037

Contacts

Gabriel Sayer, MD

773-702-9396gsayer@medicine.bsd.uchicago.edu

Daniel E Rodgers

773-702-9396drodgers3@medicine.bsd.uchicago.edu

Principal Investigator:

Gabriel Sayer, MD

Northwestern Memorial Hospital

Recruiting

Chicago, Illinois, United States, 60611

NYU School of Medicine

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

LiveMetric S.A.

Last update posted

Apr 19, 2019

Last verified

Apr, 2019

Keywords

  • Heart Failure
  • Advanced Heart Failure
  • Blood Pressure
  • High Blood Pressure
  • Low Blood Pressure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by LiveMetric S.A. on 2019-04-19.