Cardiac Output Pulmonary Arterial Catheter Compared to FloWave™ 1000

NCT00665301 | Completed

• 1 other identifier: WFW-019
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 3

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.

Conditions

Congestive Heart Failure; Ischemic Cardiomyopathy; Mitral Valve Prolapse; Mitral Regurgitation; Aortic Valve Disease; Tricuspid Regurgitation

Keywords

Non-invasive Cardiac Output

Outcome Measures

Primary Outcomes (1)

• 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

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any patient that has a Swan Ganz PAC catheter in place.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Woolsthorpe Technologies, LLC: lead

Study Sites (3)

St. Thomas Hospital

Nashville, Tennessee, 37205, United States

Location

Vanderbilt University Hospital

Nashville, Tennessee, 37232, United States

Location

Texas Heart Institute - St. Luke's Hospital

Houston, Texas, 77030, United States

Location

Related Links

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

MeSH Terms

Conditions

Heart Failure; Mitral Valve Prolapse; Mitral Valve Insufficiency; Aortic Valve Disease; Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Heart Valve Prolapse; Heart Valve Diseases

Study Officials

• Jim M. Perry, M.D.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 21, 2008
• First Posted: April 23, 2008
• Study Start: March 1, 2008
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: July 8, 2008

Record last verified: 2008-07

Locations

US (3)