Official Title: “Validation Study Comparing the Cardiac Output Pulmonary Arterial Catheter (Swan Ganz) to the FloWave™ 1000 Device”

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.

Study Type: Observational

Study Design: Case-Only, Prospective

Study Primary Completion Date: June 2008

Primary Measures

• Correlation of FloWave 1000™ Device estimated cardiac output results with Pulmonary Catheter Themodilution Push derived cardiac output results.
  • Time Frame: Simultaneous data collection during procedure. No follow-up required.
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 95 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Woolsthorpe Technologies, LLC

Overall Clinical Trial Officials and Contacts

Jim M. Perry, M.D. Study Director Unaffiliated  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00665301

Study ID Number: WFW-019

ClinicalTrials.gov Identifier: NCT00665301

Health Authority: United States: Institutional Review Board

Click here for more information about this study: Cardiac Output Pulmonary Arterial Catheter Compared to FloWave™ 1000