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Cardiac Output Pulmonary Arterial Catheter Compared to FloWave™ 1000

NCT ID: NCT00665301

Last Updated: 2008-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-03-31

Study Completion Date

2008-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Keywords

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Non-invasive Cardiac Output

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Woolsthorpe Technologies, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Woolsthorpe Technologies, LLC

Principal Investigators

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Jim M. Perry, M.D.

Role: STUDY_DIRECTOR

Locations

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St. Thomas Hospital

Nashville, Tennessee, United States

Site Status

Vanderbilt University Hospital

Nashville, Tennessee, United States

Site Status

Texas Heart Institute - St. Luke's Hospital

Houston, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.woolsthorpe.com

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

Other Identifiers

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WFW-019

Identifier Type: -

Identifier Source: org_study_id