Cardiac Function Non-Invasive Monitoring System Evaluation Trial

Cardiac Function Monitoring System Evaluation

Non-significant risk device study to conduct evaluation of the performance of new device for monitoring of cardiac function (based on previous iterations 510(k) 173156)

Study Overview

• Status: Completed
• Conditions: Cardiac Disease
• Intervention / Treatment: Device: Cardiac Performance System (NSR)

Detailed Description

Non-significant risk device study to conduct evaluation of the performance of new device for monitoring of cardiac function (based on previous iterations 510(k) 173156)

• Study Type: Observational
• Enrollment (Actual): 275

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15261
      • University of Pittsburgh Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for Pulmonary Artery Catheter procedure

Description

Inclusion Criteria:

• Adults of age 18 or older

Exclusion Criteria:

• Subjects with wounds or surgical incisions at the site of sensor placement

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cardiac Function Monitoring; Subjects will wear Cardiac Performance System (CPS) non-invasive device for brief periods during procedures including assessment by Pulmonary Artery Catheter (PAC) methods.	Device: Cardiac Performance System (NSR); Device: Cardiac Performance System Participants will be asked to wear the Cardiac Performance System, a non-invasive sensor device on their upper abdomen. The Cardiac Performance System monitoring device will continuously monitor cardiac function. The device will be worn at the time when Pulmonary Artery Catheter procedures are conducted.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac Performance System electronic data for Cardiac Output	Cardiac function metric measurement including Cardiac Output to report in L/m.	60 minutes during Pulmonary Artery Catheter procedure
Cardiac Performance System electronic data for Pulmonary Artery Pressure	Cardiac function metric measurement including Pulmonary Artery Pressure to report in mmHg.	60 minutes during Pulmonary Artery Catheter procedure
Cardiac Performance System electronic data for Pulmonary Artery Wedge Pressure	Cardiac function metric measurement including Pulmonary Artery Wedge Pressure to report in mmHg.	60 minutes during Pulmonary Artery Catheter procedure
Pulmonary Artery Catheter electronic data for Cardiac Output	Cardiac function metric measurement including Cardiac Output to report in L/m.	60 minutes during Pulmonary Artery Catheter procedure
Pulmonary Artery Catheter electronic data for Pulmonary Artery Pressure	Cardiac function metric measurement including Pulmonary Artery Pressure to report in mmHg.	60 minutes during Pulmonary Artery Catheter procedure
Pulmonary Artery Catheter electronic data for Pulmonary Artery Wedge Pressure	Cardiac function metric measurement including Pulmonary Artery Wedge Pressure to report in mmHg.	60 minutes during Pulmonary Artery Catheter procedure
Echocardiography electronic data for Ejection Fraction	Cardiac function measurement including left ventricle ejection fraction to report in percentage.	15 minutes at a time prior to or after Pulmonary Artery Catheter procedure

Collaborators and Investigators

• Sponsor: Sensydia Corporation
• Collaborators: University of Pittsburgh Medical Center
• Investigators: Principal Investigator: William Kaiser, PhD, Sensydia Corporation

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2020
• Primary Completion (Actual): February 1, 2023
• Study Completion (Actual): April 30, 2023

Study Registration Dates

• First Submitted: October 14, 2019
• First Submitted That Met QC Criteria: October 16, 2019
• First Posted (Actual): October 18, 2019

Study Record Updates

• Last Update Posted (Estimated): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: CPS_002_2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No