Impact of Hemodynamic Ramp Test-Guided HVAD RPM and Medication Adjustments on Exercise Tolerance and Quality of Life
Condition: Continous Flow Left Ventricular Device
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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:

        -  Subjects will be asked to sign this consent form.

        -  Physical exam with an assessment of heart failure symptoms, and medical history will be
           recorded

        -  Routine blood tests (about 1 tablespoon will be drawn)

        -  Subjects will be randomly assigned to one of the two testing groups. If there is time,
           the ramp test can be performed at this visit, but usually it will be scheduled to occur
           a different day in about 1 to 4 weeks.

        -  6 Minute Walk Test. This test measures how far the subject can walk in 6 minutes. If
           needed, this can be completed the day of the ramp test.

        -  Subjects will be asked to complete a questionnaire about their current quality of life.
           This will take about 10 minutes. If needed, this can be completed the day of the ramp
           test.

      Ramp Testing Groups:

        1. 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

        2. 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:

        -  Physical exam with an assessment of heart failure symptoms, and medical history will be
           recorded

        -  Routine blood tests (about 1 tablespoon will be drawn)

        -  6 Minute Walk Test. This test measures how far the subject can walk in 6 minutes.

        -  Subjects will be asked to complete a questionnaire about their current quality of life.
           This will take about 10 minutes.

        -  All subjects will undergo a Hemodynamic-Echo Ramp Test at 6 months after the baseline
           visit.
    

Intervention name(s): Echo Guided Testing; Hemodynamic-Echo Ramp Testing -
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ramp Test; Continuous Flow -Left Ventricular Assist Device (CF-LVAD); LVAD Hemodynamics