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

NCT04255108 | Completed FDA Device

• 1 other identifier: TS-IRB-0003.1
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Accuracy of Stroke Volume

  The primary objective of this study is to validate stroke volume (the amount of blood pumped by the left ventrical of the heart in one contraction) measurements made using CoVa Patch to those made using a pulmonary artery catheter and the thermodilution method. Thermodilution requires a pulmonary artery catheter and are calculated by a monitoring system based on temperature changes in the heart when a cooler solution is injected into the right atrium via the proximal port of a pulmonary artery catheter.

  4 Months

• Accuracy of Cardiac Output

  The secondary objective of this study is to validate cardiac output (the amount of blood the heart pumps per minute) measurements made using CoVa Patch to those made using a pulmonary artery catheter and the thermodilution method. Thermodilution requires a pulmonary artery catheter and are calculated by a monitoring system based on temperature changes in the heart when a cooler solution is injected into the right atrium via the proximal port of a pulmonary artery catheter.

  4 Months

Study Arms (1)

Men/Women who meet the inclusion/exclusion criteria

Device: Cova Patch

Interventions

Cova Patch DEVICE

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

Men/Women who meet the inclusion/exclusion criteria

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men and woman over the age of 18 years old.

You may qualify if:

• Male or female ≥ 18 years of age at Visit X.
• Subject is a patient in the Cardiac ICU and meets the following criteria: pulmonary artery catheterization scheduled or completed.
• Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
• Subject is not pregnant at the time of consent

You may not qualify if:

• Pregnant in the study.
• Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
• Subject is unable or unwilling to wear electrode patches as required for a period between 6 to 48 hours.

Sponsors & Collaborators

• Baxter Healthcare Corporation: lead
• University of California, Los Angeles: collaborator

Study Sites (1)

Cardiac ICU

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2020
• First Posted: February 5, 2020
• Study Start: February 19, 2020
• Primary Completion: April 9, 2020
• Study Completion: April 9, 2020
• Last Updated: January 20, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)