Validation Study Comparing the Cardiac Output Pulmonary Arterial Catheter (Swan Ganz) to the FloWave™ 1000 Device

Woolsthorpe Technologies, LLC3 sites in 1 country54 target enrollmentMarch 2008

ConditionsCongestive Heart Failure Ischemic Cardiomyopathy Mitral Valve Prolapse Mitral Regurgitation Aortic Valve Disease Tricuspid Regurgitation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Congestive Heart Failure
Sponsor: Woolsthorpe Technologies, LLC
Enrollment: 54
Locations: 3
Primary Endpoint: Correlation of FloWave 1000™ Device estimated cardiac output results with Pulmonary Catheter Themodilution Push derived cardiac output results.
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to compare cardiac output results obtained using the thermodilution push technique with the Pulmonary Arterial Catheter (PAC) to the predicted cardiac output results obtained from the non-invasive FloWave™ 1000 device.

Registry

clinicaltrials.gov

Start Date

March 2008

End Date

June 2008

Last Updated

17 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Woolsthorpe Technologies, LLC

Eligibility Criteria

Inclusion Criteria

•Adults Only: The FloWave device is intended for use on adult patients only. All subjects will be 18 years or older.
•Existing placement of a Pulmonary Arterial Catheter placed for medical reasons other than our study.

Exclusion Criteria

•Patients with aortic balloon pumps and cardiac mechanical assist devices will be excluded from study enrollment if the devices are present during the screening process. If patients have cardiac assist devices inserted after enrollment in the study, cardiac output data will be collected with both the PAC and FloWave device and will be evaluated as a subset analysis population at the conclusion of the study.
•Patients with intracardiac shunts will be excluded from this study.
•FloWave cardiac output determinations are dependent on detection of a pulse. If no peripheral pulse can be detected the device will not be able to perform a measurement and this will be indicated to the user.
•Patients who are not in a steady hemodynamic state shall be excluded from the study.
•Presence of arrhythmias: Patients with arrhythmias are excluded from the study when not in a steady hemodynamic state. If a patient has a history of arrhythmia or is currently experiencing an arrhythmia but is in a maintained hemodynamic state, they will not be excluded from enrollment into the study. Their clinical symptoms and cardiac rhythm will be evaluated and noted in the patient data record.
•Inability or unwillingness of subject or the subject's legally authorized representative to give informed consent.