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The main purpose of this study is to compare Echo-guided testing to the Hemodynamic-Echo Ramp Tests to determine which method of testing provides better information for adjusting pump speed and medical treatment for Left Ventricular Assist Device (LVAD) patients. Better adjustments may provide better quality of life, exercise tolerance and reduced unwanted cardiac events over a 6-month period.
All Left Ventricular Assist Device (LVAD)patients undergo testing to determine the best pumping speed for their Left Ventricular Assist Device (LVAD) and to gather measurements that help guide medical treatment. The testing uses echocardiography ("echo", ultrasound images of the heart) to create heart images and make measurements while gradually increasing the Left Ventricular Assist Device (LVAD) heart pump speed. Each time the pump speed is increased, images and measurements are taken. This is called a ramp test.
The ramp testing may also be performed during a right heart catheterization procedure. In a catheterization procedure, a doctor inserts a thin, flexible tube (catheter) into a vein or artery in the upper leg (groin), arm or neck and guides it to the heart using X-ray imaging. Doctors normally perform this procedure to measure the pressure and blood flow in the heart (otherwise called hemodynamic measurements). If the ramp testing is performed during this procedure, then the doctors have additional measurements to consider before choosing a final speed for the Left Ventricular Assist Device (LVAD) pump and appropriate medical treatment.
All of the procedures in this study are considered standard of care. The research part is randomly assigning the subject to one of the two methods of testing in this study. Subjects have a 50/50 chance of being in either testing group.
Baseline Visit (1 - 3 months after Left Ventricular Assist Device (LVAD) implant)
The following will be performed:
Ramp Testing Groups:
Echo Guided Testing - This testing uses echocardiography to create images of the heart and make measurements while gradually increasing the heart pump speed. The final pump speed and medical treatment are determined using the echo measurements. This will take about 45 minutes.
OR
Hemodynamic-Echo Ramp Testing - This testing is performed during a right heart catheterization procedure which provides hemodynamic measurements (pressure and blood flow) in addition to the echocardiography measurements. With this method, more echo images and measurements are taken. The final pump speed and medical treatment adjustments are made using the hemodynamic measurements as well as the information from the echo. This test will take about 1 hour and 45 minutes.
6 Months after Baseline Visit
The following will be performed:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1) Echo Guided Testing - | Active Comparator | This testing uses echocardiography to create images of the heart and make measurements while gradually increasing the heart pump speed. The final pump speed and medical treatment are determined using the echo measurements. This will take about 45 minutes. |
|
| 2) Hemodynamic-Echo Ramp Testing - | Active Comparator | This testing is performed during a right heart catheterization procedure which provides hemodynamic measurements (pressure and blood flow) in addition to the echocardiography measurements. With this method, more echo images and measurements are taken. The final pump speed and medical treatment adjustments are made using the hemodynamic measurements as well as the information from the echo. This test will take about 1 hour and 45 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Echo Guided Testing | Procedure |
| ||
| Hemodynamic-Echo Ramp Testing - |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical parameters most likely to be impacted by hemodynamic-echo ramp tests | 6 Walk Test | 6 Months |
| Heart Failure Readmission | Composite end-point of heart failure readmission. | 6 Months |
| Quality of Life: Kansas City Cardiomyopathy Questionnaire (KCCQ) | Kansas City Cardiomyopathy Questionnaire (KCCQ) a summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains in which scores are transformed to a range of 0-100. | 6 Months |
| New York Heart Association (NYHA) Class | 6 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC San Diego Medical Center | San Diego | California | United States | |||
| Stanford Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30946600 | Derived | Uriel N, Burkhoff D, Rich JD, Drakos SG, Teuteberg JJ, Imamura T, Rodgers D, Raikhelkar J, Vorovich EE, Selzman CH, Kim G, Sayer G. Impact of Hemodynamic Ramp Test-Guided HVAD Speed and Medication Adjustments on Clinical Outcomes. Circ Heart Fail. 2019 Apr;12(4):e006067. doi: 10.1161/CIRCHEARTFAILURE.119.006067. |
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| Procedure |
|
| Stanford |
| California |
| United States |
| Northwestern University | Chicago | Illinois | United States |
| The University of Chicago | Chicago | Illinois | United States |
| Montefiore Medical Center | The Bronx | New York | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | United States |
| University of Washington School of Medicine | Seattle | Washington | United States |