Cardiac Performance System Data Collection Study

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05866666

Enrollment

115

Registered

2023-05-19

Start date

2023-05-30

Completion date

2024-05-31

Last updated

2023-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Disease

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)

Interventions

DEVICECardiac 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.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

22 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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 Artery Pressure	10 minutes before cardiac catheterization procedure	Cardiac function metric measurement including Pulmonary Artery Pressure to report in mmHg.
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 Artery Pressure	60 minutes during cardiac catheterization procedure	Cardiac function metric measurement including Pulmonary Artery Pressure to report in mmHg.
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.

Countries

United States

Contacts

Primary ContactSensydia

info@sensydia.com6618774670

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026