Cardiac Output Pulmonary Arterial Catheter Compared to FloWave™ 1000

Sponsor

Woolsthorpe Technologies, LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT00665301

Collaborator

(none)

Enrollment

Locations

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Congestive Heart Failure Ischemic Cardiomyopathy Mitral Valve Prolapse Mitral Regurgitation Aortic Valve Disease Tricuspid Regurgitation

Study Design

Study Type:

Observational

Actual Enrollment :

54 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Mar 1, 2008

Actual Primary Completion Date :

Jun 1, 2008

Actual Study Completion Date :

Jun 1, 2008

Outcome Measures

Primary Outcome Measures

Correlation of FloWave 1000™ Device estimated cardiac output results with Pulmonary Catheter Themodilution Push derived cardiac output results. [Simultaneous data collection during procedure. No follow-up required.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 95 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Thomas Hospital	Nashville	Tennessee	United States	37205
2	Vanderbilt University Hospital	Nashville	Tennessee	United States	37232
3	Texas Heart Institute - St. Luke's Hospital	Houston	Texas	United States	77030