Cardiac Function Non-Invasive Monitoring System Evaluation Trial

Cardiac Disease Clinical Trial

Official title:

Cardiac Function Monitoring System Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04131725
• Other study ID #: CPS_002_2019
• Status: Completed
• Start date: November 9, 2020
• Est. completion date: April 30, 2023

Study information

• Verified date: November 2023
• Source: Sensydia Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 275
• Est. completion date: April 30, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults of age 18 or older

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Cardiac Disease
• Heart Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Sensydia Corporation	University of Pittsburgh Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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