Principal Investigator: Craig Selzman
Keywords: Advanced Heart Failure , Counterpulsation , Heart Transplant , Mechanical Circulatory Support , Heart Assist System , Intra Aortic Balloon Pump , Blood Pump , Bridge to Transplant (BTT) , LVAD , Investigational Device Department: Cardiothoracic Division
IRB Number: 00112028 Co Investigator: Stavros Drakos
Specialty: Cardiology, Transplant Surgery, Cardiothoracic Surgery, Cardiology, Cardiothoracic Surgery
Sub Specialties: Heart Failure, Heart Failure, Heart Transplant, Heart Transplant
Recruitment Status: Active, not recruiting

Contact Information

Ashley Elmer
ashley.elmer@hsc.utah.edu
801-585-6775

Simple Summary

This study will evaluate a device called the NuPulseCV intravascular ventricular assist system (iVAS) that is similar to an IABP. The purpose of this study is to:(1) assess if the iVAS can help improve blood circulation, (2) gain a better understanding of how this device could impact your health, (3) determine human interaction with the device, and (4) assess the portability of this device

Inclusion Criteria

Inclusion Criteria

  1. Age ≥ 18 years
  2. If female, 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. Advanced heart failure refractory to guideline directed medical therapy needing circulatory support (NYHA Class III or Class IV within the previous 12 months)
  4. Abdominal aortic diameter > 1.9 cm proximal to the renal arteries
  5. Subclavian (axillary) diameter ≥ 6.5 mm at site of planned iVAS implantation

Exclusion Criteria

Exclusion Criteria

  1. Hypotension requiring any one of the following drugs:
    1. epinephrine,
    2. norepinephrine,
    3. vasopressin,
    4. methylene blue
    5. phenylephrine, or
    6. angiotensin II
  2. Single inotrope therapy dosing greater than the following:
    1. milrinone > 0.5 mcg/kg/min,
    2. dobutamine > 7.5 mcg/kg/min,
    3. dopamine > 7.5 mcg/kg/min, or
    4. epinephrine > 0.02 mcg/kg/min
  3. Dual inotrope therapy where the dosing of any one inotrope is greater than the following:
    1. milrinone ≥ 0.25 mcg/kg/min,
    2. dobutamine ≥ 3 mcg/kg/min,
    3. dopamine ≥ 3 mcg/kg/min, or
    4. epinephrine ≥ 0.01 mcg/kg/min
  4. Supported by more than two inotropes at any dose
  5. Low blood pressure defined as:
    1. Mean Blood Pressure < 70 mmHg while receiving IABP support, or
    2. Systolic Blood Pressure < 80 while not supported with IABP
  6. Currently receiving circulatory support defined as:
    1. Acute, temporary mechanical circulatory support including ECMO, Impella, TandemLife, or equivalents; or
    2. Any durable VAD
  7. Persistent resting Heart Rate > 110 bpm
  8. Premature ventricular contractions (PVC) > 5% burden
  9. Permanent or persistent atrial fibrillation without atria-ventricular (A-V) node ablation and ventricular pacing
  10. Subclavian stenosis or stent on the side of implantation
  11. Greater than 80% carotid stenosis on side of implantation
  12. Aortic valve disease defined as:
    1. Aortic valve regurgitation >2+ (where 0-none, 1-trace, 2-mild, 3-moderate, 4-severe), or
    2. Severe aortic valve stenosis
  13. Significant abnormalities of the aorta (e.g. aneurysms, coarctation of the aorta, or an extremely tortuous aorta
  14. Severe end-organ dysfunction or failure defined as any one of the following:
    1. eGFR < 25 ml/min/1.73 m2 AND not responsive to inotropic therapy,
    2. Shock Liver OR Bilirubin > 3 mg/dL without chronic liver disease,
    3. Severe chronic obstructive pulmonary disease (COPD) defined by resting hypoxemia AND CO2 retention (pCO2 > 55 mmHg) OR FEV1 < 30% of predicted,
    4. Fixed pulmonary hypertension >6 Wood Units, or
    5. History of hemorrhagic or non-hemorrhagic cerebrovascular accident within 30 days of enrollment
  15. Pneumonia or systemic infection with bacteremia despite treatment.
  16. Any condition other than dyspnea or fatigue of heart failure that would severely limit ambulation (e.g. severe arthritis, orthopedic problems of the lower extremities, massive obesity).
  17. Concomitant, non-cardiac disease process with life expectancy < 1 year.
  18. Any psychosocial problems or altered mental status that the heart team believes likely to negatively affect study protocol compliance including unresolved psychiatric disorders or active medical non-compliance
  19. Inability to give informed consent due to altered mental status or dementia.
  20. Any other condition the heart team believes inappropriate for this study.

 

Participant Reimbursement

There is no payment for participation in the study.