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Validation of a Sensor for Non-invasive Measurement of Stroke Volume and Cardiac Output

NCT04255108 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2022-01-20

No results posted yet for this study

Summary

toSense, Inc. has developed a novel, non-invasive, body-worn sensor -CoVa Patch-that offers an alternative to invasive continuous cardiac output monitoring. To validate this new sensor's measurements of stroke volume and cardiac output, toSense, Inc. will conduct a study that compares its measurement performance to that from a pulmonary artery catheter using the thermodilution method.

Conditions

  • Cardiac Failure

Interventions

DEVICE

Cova Patch

CoVa Patch will measure quasi-continuously, approximately every 5 minutes for a period between 6 to 48 hours

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-19
Primary Completion
2020-04-09
Completion
2020-04-09
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04255108 on ClinicalTrials.gov