Echocardiogram and Cardiac Performance System (CPS) Ejection Fraction Validation Study

• Sponsor: Stephen Esper (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05104307
• Collaborator: Sensydia Corporation (Industry)
• Enrollment: 30
• Location: 1
• Anticipated Duration (Months): 28.7
• Patients Per Site Per Month: 1

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
Heart Diseases	Device: Cardiac Performance System (CPS) Device

Detailed Description

This validation study will help to establish feasibility of using the CPS monitor to screen patients for ejection fraction (EF), CO, PASP and wedge pressure compared to a standard echocardiogram. No clinical decisions will be made as a result of the CPS device EF value and this measurement will be taken for comparison purposes only.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 30 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Echocardiogram and Cardiac Performance System (CPS) Ejection Fraction Validation Study
• Actual Study Start Date: Nov 9, 2021
• Anticipated Primary Completion Date: Mar 1, 2024
• Anticipated Study Completion Date: Mar 31, 2024

Arms and Interventions

Arm

Intervention/Treatment

Cardiac Performance System (NSR) Subjects will wear Cardiac Performance System (CPS) non-invasive device during their standard echocardiogram

Device: Cardiac Performance System (CPS) Device; CPS is a passive measurement system that acquires signals from multiple sensor sources that monitor cardiac heart sounds. The passive sensor systems measure sound only and do not produce energy. The CPS system also includes a Patient Monitor device that acquires data from the sensors as well as from three standard ECG electrodes. The CPS system does not acquire or store any protected health information or any subject characteristics. The CPS system has received FDA clearance K173156. Note that the CPS system was previously named Integrated CardioRespiratory (ICR) system. The CPS is FDA cleared for the ejection fraction (EF) assessment which will be its intended use for this study.

Outcome Measures

Primary Outcome Measures

1. Cardiac Performance System electronic data for Ejection Fraction [60 minutes during Echocardiography procedure]

   Cardiac function measurement including left ventricle ejection fraction to report in percentage

2. Cardiac Performance System electronic data for Cardiac Output [60 minutes during Echocardiography procedure]

   Cardiac function metric measurement including Cardiac Output to report in L/m

3. Cardiac Performance System electronic data for Pulmonary Artery Pressure [60 minutes during Echocardiography procedure]

   Cardiac function metric measurement including Pulmonary Artery Pressure to report in mmHg.

4. Cardiac Performance System electronic data for Pulmonary Artery Wedge Pressure [60 minutes during Echocardiography procedure]

   Cardiac function metric measurement including Pulmonary Artery Wedge Pressure to report in mmHg

5. Echocardiography electronic data for Ejection Fraction [60 minutes during Echocardiography procedure]

   Cardiac function measurement including left ventricle ejection fraction to report in percentage

6. Echocardiography electronic data for Cardiac Output [60 minutes during Echocardiography procedure]

   Cardiac function metric measurement including Cardiac Output to report in L/m

7. Echocardiography electronic data for Pulmonary Artery Pressure [60 minutes during Echocardiography procedure]

   Cardiac function metric measurement including Pulmonary Artery Pressure to report in mmHg.

8. Echocardiography electronic data for Pulmonary Artery Wedge Pressure [60 minutes during Echocardiography procedure]

   Cardiac function metric measurement including Pulmonary Artery Wedge Pressure to report in mmHg

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

Inclusion Criteria:

• Patients over 18 scheduled for a standard echocardiogram

Exclusion Criteria:

• Patients with heart transplant history

• Patients with a Implanted Left Ventricular Assist Device (LVAD)

• Patients who have surgical scars, wounds, or bandages at the site of sensor placement

• Inadequate TTE imaging windows in left lateral position

• Otherwise deemed by the investigator as medically unfit to participate

• Chest deformities including, for example, pectus excavatum

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UPMC Montefiore Hospital	Pittsburgh	Pennsylvania	United States	15212

Sponsors and Collaborators

• Stephen Esper
• Sensydia Corporation

Investigators

• Principal Investigator: Stephen L Esper, MD, MBA, University of Pittsburgh Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stephen Esper, Assistant Professor, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT05104307
• Other Study ID Numbers: STUDY21050167
• First Posted: Nov 2, 2021
• Last Update Posted: Mar 31, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Stephen Esper, Assistant Professor, University of Pittsburgh: cardiovascular
• Additional relevant MeSH terms: Heart Diseases

Study Results

No Results Posted as of Mar 31, 2022