Congestive Heart Failure Clinical Trial
Official title:
Validation Study Comparing the Cardiac Output Pulmonary Arterial Catheter (Swan Ganz) to the FloWave™ 1000 Device
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 |
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.
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. |
Observational Model: Case-Only, Time Perspective: Prospective
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 |
Lead Sponsor | Collaborator |
---|---|
Woolsthorpe Technologies, LLC |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT04115735 -
His Bundle Recording From Subclavian Vein
|
||
Recruiting |
NCT05562037 -
Stepped Care vs Center-based Cardiopulmonary Rehabilitation for Older Frail Adults Living in Rural MA
|
N/A | |
Completed |
NCT05563701 -
Evaluation of the LVivo Image Quality Scoring (IQS)
|
||
Recruiting |
NCT05865184 -
Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD
|
||
Completed |
NCT04037436 -
Functional Exercise and Nutrition Education Program for Older Adults
|
N/A | |
Recruiting |
NCT04703842 -
Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in Heart Failure With Reduced Ejection Fraction
|
Phase 1/Phase 2 | |
Terminated |
NCT05594940 -
Heart Failure Monitoring With a Portable Ultrasound Device With Artificial Intelligence Assisted Tools: A Multi-Phase Observational Feasibility Study
|
||
Recruiting |
NCT04982081 -
Treating Congestive HF With hiPSC-CMs Through Endocardial Injection
|
Phase 1 | |
Completed |
NCT04394754 -
Evaluating Efficacy of Digital Health Technology in the Treatment of Congestive Heart Failure
|
N/A | |
Active, not recruiting |
NCT01385176 -
Neural Cardiac Therapy for Heart Failure Study (NECTAR-HF)
|
N/A | |
Not yet recruiting |
NCT05516290 -
Evaluating Clinical Trial Experiences of Individuals With Congestive Heart Failure
|
||
Terminated |
NCT02788656 -
Pulmonary Artery Pressure Reduction With ENTresto (Sacubitril/Valsartan)
|
Phase 4 | |
Completed |
NCT02885636 -
Inhaled Beta-adrenergic Agonists to Treat Pulmonary Vascular Disease in Heart Failure With Preserved EF (BEAT HFpEF): A Randomized Controlled Trial
|
Phase 3 | |
Completed |
NCT02252757 -
Assess Measurements of Wireless Cardiac Output Device
|
N/A | |
Terminated |
NCT02205411 -
Clinical Trial to Evaluate the the ReliantHeart HeartAssist 5® VAD System in Patients Awaiting Heart Transplantation
|
N/A | |
Completed |
NCT01362855 -
Advance Care Planning Evaluation in Hospitalized Elderly Patients
|
||
Withdrawn |
NCT00346177 -
Stem Cell Study for Patients With Heart Failure
|
Phase 2 | |
Completed |
NCT01476995 -
Prognostic Indicators as Provided by the EPIC ClearView
|
N/A | |
Active, not recruiting |
NCT01058837 -
SCD-HeFT 10 Year Follow-up
|
N/A | |
Completed |
NCT00957541 -
Evaluation of a Diagnostic Feature in a Cardiac Resynchronization Therapy (CRT) Device
|
Phase 2 |