Cardiac Output Pulmonary Arterial Catheter Compared to FloWave™ 1000

This study has been completed.
Sponsor:
Information provided by:
Woolsthorpe Technologies, LLC
ClinicalTrials.gov Identifier:
NCT00665301
First received: April 21, 2008
Last updated: July 7, 2008
Last verified: July 2008
  Purpose

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

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Woolsthorpe Technologies, LLC:

Primary Outcome 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. ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: March 2008
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00665301

Locations
United States, Tennessee
Vanderbilt University Hospital
Nashville, Tennessee, United States, 37232
St. Thomas Hospital
Nashville, Tennessee, United States, 37205
United States, Texas
Texas Heart Institute - St. Luke's Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Woolsthorpe Technologies, LLC
Investigators
Study Director: Jim M. Perry, M.D.
  More Information

No publications provided

Responsible Party: Jeannie Brooks, RN, BSN/Director, Clinical Trials, Woolsthorpe Technologies, LLC
ClinicalTrials.gov Identifier: NCT00665301     History of Changes
Other Study ID Numbers: WFW-019
Study First Received: April 21, 2008
Last Updated: July 7, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Woolsthorpe Technologies, LLC:
Non-invasive Cardiac Output

Additional relevant MeSH terms:
Heart Failure
Mitral Valve Insufficiency
Mitral Valve Prolapse
Neurocirculatory Asthenia
Orthostatic Intolerance
Prolapse
Tricuspid Valve Insufficiency
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases
Heart Valve Diseases
Heart Valve Prolapse
Anxiety Disorders
Mental Disorders
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on April 16, 2014