Clinical Research Studies

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Cardiogenic Shock
• Age: Between 18 years - 120 years
• Gender: Male or Female

• Other Inclusion Criteria:
  

  1. Subjects who are at least 18 years old
  2. Female subjects who are postmenopausal or surgically sterilized, or have a negative pregnancy test within seven (7) days of invasive testing and who are using at least two reliable methods of contraception.
  3. Subjects with advanced heart failure refractory to guideline directed medical therapy needing circulatory support
  4. Subjects with abdominal aortic diameter > 1.9 cm proximal to the renal arteries
  5. Subjects with subclavian (axillary) diameter = 6.5 mm at site of planned iVAS implantation

  
  

You may not be eligible for this study if the following are true:

• 1. Subjects with hypotension requiring any one of the following drugs:epinephrine, norepinephrine, vasopressin, methylene blue, phenylephrine or angiotensin II
  2. Subjects with single inotrope therapy dosing greater than the following: milrinone > 0.5 mcg/kg/min, dobutamine > 7.5 mcg/kg/min, dopamine > 7.5 mcg/kg/min, or epinephrine > 0.02 mcg/kg/min
  3. Subjects with dual inotrope therapy where the dosing of any one inotrope is greater than the following: milrinone = 0.25 mcg/kg/min, dobutamine = 3 mcg/kg/min, dopamine = 3 mcg/kg/min, or epinephrine = 0.01 mcg/kg/min
  4. Subjects who are supported by more than two inotropes at any dose
  5. Subjects with low blood pressure
  6. Subjects currently receiving circulatory support
  7. Subjects with subclavian stenosis or stent on the side of implantation or has greater than 80% carotid stenosis on side of implantation
  8. Subjects with aortic valve disease or significant abnormalities of the aorta
  9. Subjects with severe end-organ dysfunction or failure
  10. Subjects with pneumonia or systemic infection with bacteremia despite treatment
  11. Subjects with concomitant, non-cardiac disease process with life expectancy < 1 year.
  12. Subjects with inability to give informed consent due to altered mental status or dementia
  13. Subjects with any other condition the heart team believes inappropriate for this study
  14. Subjects with any condition other than dyspnea or fatigue of heart failure that would severely limit ambulation