Cardiac Performance System Data Collection Study

Recruiting

• Conditions: Cardiac Disease
• Interventions: Device: Cardiac Performance System (NSR)

• Registration Number: NCT05866666
• Lead Sponsor: Sensydia Corporation

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)

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 Timeline

• Study First Submitted: 2023-05-10
• Study First Submitted QC: 2023-05-10
• Study First Posted: 2023-05-19
• Study Start: 2023-05-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-20
• Last Update Posted: 2023-11-21
• Primary Completion: 2024-05-31
• Study Completion: 2024-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 115

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

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

Trial Locations

Locations (1)

Orlando Health; 🇺🇸 Orlando, Florida, United States