Congestive Heart FailureNCT00665301
Cardiac Output Pulmonary Arterial Catheter Compared to FloWave™ 1000
An observational study of Congestive Heart Failure and Ischemic Cardiomyopathy, run by Woolsthorpe Technologies, LLC at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Congestive Heart Failure, Ischemic Cardiomyopathy, Mitral Valve Prolapse
- How many people
- 54 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2008to Jun 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any patient that has a Swan Ganz PAC catheter in place.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Texas Heart Institute - St. Luke's Hospital
Houston, Texas, 77030
St. Thomas Hospital
Nashville, Tennessee, 37205
Vanderbilt University Hospital
Nashville, Tennessee, 37232
About this study
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.
- Conditions
- Congestive Heart Failure, Ischemic Cardiomyopathy, Mitral Valve Prolapse, Mitral Regurgitation, Aortic Valve Disease, Tricuspid Regurgitation
- Keywords
- Non-invasive Cardiac Output
- Medical subject headings
- Heart Failure, Mitral Valve Prolapse, Mitral Valve Insufficiency, Aortic Valve Disease, Tricuspid Valve Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of FloWave 1000™ Device estimated cardiac output results with Pulmonary Catheter Themodilution Push derived cardiac output results.
Measured: Simultaneous data collection during procedure. No follow-up required.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Woolsthorpe Technologies, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jim M. Perry, M.D., Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00665301
- Sponsor's protocol ID
- WFW-019
- Status last verified
- Jul 2008
- First submitted
- 21 Apr 2008
- Last updated
- 8 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation Study Comparing the Cardiac Output Pulmonary Arterial Catheter (Swan Ganz) to the FloWave™ 1000 Device
- ClinicalTrials.gov ID
- NCT00665301
- Acronym / sponsor ID
- WFW-019
- Conditions
- Congestive Heart Failure, Ischemic Cardiomyopathy, Mitral Valve Prolapse, Mitral Regurgitation, Aortic Valve Disease, Tricuspid Regurgitation
- Keywords
- Non-invasive Cardiac Output
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Woolsthorpe Technologies, LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 23 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient that has a Swan Ganz PAC catheter in place.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2008.
- Click here for more information about this study: Cardiac Output Pulmonary Arterial Catheter Compared to FloWave™ 1000Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jim M. Perry, M.D. study director
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congestive Heart Failure and Ischemic Cardiomyopathy, run by Woolsthorpe Technologies, LLC at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2008.