Clinical trial NCT00665301: Cardiac Output Pulmonary Arterial Catheter Compared to FloWave™ 1000
Official title: Validation Study Comparing the Cardiac Output Pulmonary Arterial Catheter (Swan Ganz) to the FloWave™ 1000 Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congestive Heart Failure
Ischemic Cardiomyopathy
Mitral Valve Prolapse
Mitral Regurgitation
Aortic Valve Disease
Tricuspid Regurgitation
Keywords: Non-invasive Cardiac Output
Lead sponsor: Woolsthorpe Technologies, LLC
Sponsor class: INDUSTRY
First posted: 2008-04-23
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient that has a Swan Ganz PAC catheter in place.

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.


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.

Primary outcomes:
measure: Correlation of FloWave 1000™ Device estimated cardiac output results with Pulmonary Catheter Themodilution Push derived cardiac output results.
timeFrame: Simultaneous data collection during procedure. No follow-up required.
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: St. Thomas Hospital
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Hospital
state: Tennessee
city: Houston
country: United States
facility: Texas Heart Institute - St. Luke's Hospital
state: Texas
Study officials:
name: Jim M. Perry, M.D.
role: STUDY_DIRECTOR
References: