Cardiac Output Pulmonary Arterial Catheter Compared to FloWave™ 1000

Congestive Heart Failure Clinical Trial

Official title:

Validation Study Comparing the Cardiac Output Pulmonary Arterial Catheter (Swan Ganz) to the FloWave™ 1000 Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00665301
• Other study ID #: WFW-019
• Status: Completed
• Phase: N/A
• First received: April 21, 2008
• Last updated: July 7, 2008
• Start date: March 2008
• Est. completion date: June 2008

Study information

• Verified date: July 2008
• Source: Woolsthorpe Technologies, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aortic Valve Disease
• Cardiomyopathies
• Congestive Heart Failure
• Heart Defects, Congenital
• Heart Failure
• Heart Valve Diseases
• Ischemic Cardiomyopathy
• Mitral Regurgitation
• Mitral Valve Insufficiency
• Mitral Valve Prolapse
• Tricuspid Regurgitation
• Tricuspid Valve Insufficiency

Locations

Country	Name	City	State
United States	Texas Heart Institute - St. Luke's Hospital	Houston	Texas
United States	St. Thomas Hospital	Nashville	Tennessee
United States	Vanderbilt University Hospital	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Woolsthorpe Technologies, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No