Cardiac Function Non-Invasive Monitoring System Evaluation Trial

Sponsor

Sensydia Corporation (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04131725

Collaborator

University of Pittsburgh Medical Center (Other)

200

Enrollment

Location

28.7

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Cardiac Disease	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 Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Cardiac Function Monitoring System Evaluation

Actual Study Start Date :

Nov 9, 2020

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

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.
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.
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.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Adults of age 18 or older

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15261

Sponsors and Collaborators

Sensydia Corporation
University of Pittsburgh Medical Center

Investigators

Principal Investigator: William Kaiser, PhD, Sensydia Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sensydia Corporation

ClinicalTrials.gov Identifier:

NCT04131725

Other Study ID Numbers:

CPS_002_2019

First Posted:

Oct 18, 2019

Last Update Posted:

May 5, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Heart Diseases

Study Results

No Results Posted as of May 5, 2022