NCT04131725 - Cardiac Function Non-Invasive Monitoring System Evaluation Trial | Crick | Crick

Cardiac Function Non-Invasive Monitoring System Evaluation Trial

N/ACompletedNCT04131725

Sensydia Corporation275 enrolled

Overview

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)

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

275

Conditions

Cardiac Disease

Interventions

Cardiac Performance System (NSR)DEVICE

Device: Cardiac Performance System 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. The device will be worn at the time when Pulmonary Artery Catheter procedures are conducted.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Adults of age 18 or older Exclusion Criteria: * Subjects with wounds or surgical incisions at the site of sensor placement

Locations (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

Cardiac Performance System electronic data for Cardiac Output

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

Time frame: 60 minutes during Pulmonary Artery Catheter procedure

Cardiac Performance System electronic data for Pulmonary Artery Pressure

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

Time frame: 60 minutes during Pulmonary Artery Catheter procedure

Cardiac Performance System electronic data for Pulmonary Artery Wedge Pressure

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

Time frame: 60 minutes during Pulmonary Artery Catheter procedure

Pulmonary Artery Catheter electronic data for Cardiac Output

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

Time frame: 60 minutes during Pulmonary Artery Catheter procedure

Pulmonary Artery Catheter electronic data for Pulmonary Artery Pressure

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

Time frame: 60 minutes during Pulmonary Artery Catheter procedure

Pulmonary Artery Catheter electronic data for Pulmonary Artery Wedge Pressure

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

Time frame: 60 minutes during Pulmonary Artery Catheter procedure

Echocardiography electronic data for Ejection Fraction

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

Data from ClinicalTrials.gov

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