Cardiac Performance System Data Collection Study

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 Overview

• Status: Recruiting
• Conditions: Cardiac Disease
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 115

Contacts and Locations

• Study Contact: Name: Sensydia; Phone Number: 6618774670; Email: info@sensydia.com

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32806
      • Recruiting
      • Orlando Health
      • Contact: Yahaira Ortiz-Gonzalez, MD; Phone Number: 321-843-9657

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for cardiac catheterization procedure

Description

Inclusion Criteria:

• Ability to provide written informed consent
• 22 years of age or older
• Referred for cardiac catheterization for reasons including heart failure, evaluation before transplant, pulmonary hypertension, shortness of breath, valvular disease, etc.

Exclusion Criteria:

• Previous Heart Transplant
• Presence of Left Ventricular Assist Device
• Presence of a Holter monitor or any other electrical leads on the chest at the time of sensor placement
• Surgical scars/wounds/bandages/ports at the site of sensor placement

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cardiac Function Monitoring; Subjects scheduled for cardiac catheterization will undergo measurement with the Cardiac Performance System non-invasive device for a brief period before the catheterization procedure.	Device: Cardiac Performance System (NSR); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Cardiac Performance System electronic data for Cardiac Output	Cardiac function metric measurement including Cardiac Output to report in L/m.	10 minutes before cardiac catheterization procedure
Cardiac Performance System electronic data for Pulmonary Artery Pressure	Cardiac function metric measurement including Pulmonary Artery Pressure to report in mmHg.	10 minutes before cardiac catheterization procedure
Cardiac Performance System electronic data for Pulmonary Capillary Wedge Pressure	Cardiac function metric measurement including Pulmonary Capillary Wedge Pressure to report in mmHg.	10 minutes before cardiac catheterization procedure
Pulmonary Artery Catheter electronic data for Cardiac Output	Cardiac function metric measurement including Cardiac Output to report in L/m.	60 minutes during cardiac catheterization 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 cardiac catheterization procedure
Pulmonary Artery Catheter electronic data for Pulmonary Capillary Wedge Pressure	Cardiac function metric measurement including Pulmonary Capillary Wedge Pressure to report in mmHg.	60 minutes during cardiac catheterization procedure

Collaborators and Investigators

• Sponsor: Sensydia Corporation
• Collaborators: Orlando Health, Inc.
• Investigators: Principal Investigator: Yahaira Ortiz-Gonzalez, MD, Orlando Health

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2023
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: May 10, 2023
• First Submitted That Met QC Criteria: May 10, 2023
• First Posted (Actual): May 19, 2023

Study Record Updates

• Last Update Posted (Estimated): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: CPS_ORLANDO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No