Cardiac Performance System Data Collection Study

Cardiac Disease Clinical Trial

Official title:

Cardiac Performance System Data Collection Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05866666
• Other study ID #: CPS_ORLANDO
• Status: Recruiting
• Start date: May 30, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: November 2023
• Source: Sensydia Corporation
• Contact: Sensydia
• Phone: 6618774670
• Email: info[@]sensydia.com
• 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: Recruiting
• Enrollment: 115
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Disease
• Heart Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	Orlando Health	Orlando	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Sensydia Corporation	Orlando Health, Inc.

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.	10 minutes before cardiac catheterization procedure
Primary	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
Primary	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
Primary	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
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 cardiac catheterization procedure
Primary	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
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