Cardiac Function Non-Invasive Monitoring System Evaluation Trial

NCT04131725 | Completed DMC

• 1 other identifier: CPS_002_2019
• Study Type: observational
• Target: 275
• Locations: 1 country
• Sites: 1

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)

Conditions

Cardiac Disease

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (1)

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)

Interventions

Cardiac Performance System (NSR) DEVICE

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.

Cardiac Function Monitoring

Eligibility Criteria

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

Study Population

Patients scheduled for Pulmonary Artery Catheter procedure

You may qualify if:

• Adults of age 18 or older

You may not qualify if:

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

Sponsors & Collaborators

• Sensydia Corporation: lead
• University of Pittsburgh Medical Center: collaborator

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15261, United States

Location

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• William Kaiser, PhD

  Sensydia Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2019
• First Posted: October 18, 2019
• Study Start: November 9, 2020
• Primary Completion: February 1, 2023
• Study Completion: April 30, 2023
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)