Cardiac Function Non-Invasive Monitoring System Evaluation Trial

Completed

• Conditions: Cardiac Disease
• Interventions: Device: Cardiac Performance System (NSR)

• Registration Number: NCT04131725
• Lead Sponsor: Sensydia Corporation

Brief Summary

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)

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 Timeline

• Study First Submitted: 2019-10-14
• Study First Submitted QC: 2019-10-16
• Study First Posted: 2019-10-18
• Study Start: 2020-11-09
• Primary Completion: 2023-02-01
• Study Completion: 2023-04-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-20
• Last Update Posted: 2023-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 275

Inclusion Criteria

• Adults of age 18 or older

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cardiac Function Monitoring	Cardiac Performance System (NSR)	Subjects will wear Cardiac Performance System (CPS) non-invasive device for brief periods during procedures including assessment by Pulmonary Artery Catheter (PAC) methods.

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States