Principal Investigator: Craig Selzman
Keywords: Heart Failure , LVAD , Artificial Heart , Heart Surgery Department: Cardiothoracic Division
IRB Number: 00060024 Co Investigator: Stavros Drakos
Specialty: Cardiology, Cardiothoracic Surgery, Cardiothoracic Surgery
Sub Specialties: Heart Failure, Cardiac Mechanical Support, Heart Failure
Recruitment Status: Recruiting

Contact Information

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

Simple Summary

You have been identified as a potential participant in this study because you have severe heart failure and are not a candidate for heart transplant. Your heart failure has failed to respond to optimal medial management including dietary restrictions and heart medications. Your doctors have discussed with you the options of mechanical circulatory assistance (surgical placement of a mechanical heart pump, or Left Ventricular Assist Device (LVAD)), that will help the blood flow from your heart to the rest of your body. At this time you have been identified as NOT a candidate for heart transplant and thus a LVAD may help your heart for a long period of time often called Destination Therapy. The purpose of this study is to see if the Jarvik 2000 Left Ventricular Assist System (LVAS) helps your heart over a long period of time. The investigational Jarvik 2000 LVAS is being studied to determine its safety and ability to increase blood flow compared to the Thoratec HeartMate II LVAD (a LVAD currently approved by the US Food and Drug Administration (FDA) for destination therapy). Investigational means the study device being tested has not been approved by the United States FDA for use in the United States.

Inclusion Criteria

Inclusion Criteria
1. Cardiac transplantation ineligible.
2. Late stage heart failure in NYHA Class IIIb or IV for at least 45 of past 60 days.
3. LVEF = 25% or less
4. Patients on Optimal Medical Management (OMM) as defined in Section 9.2 OR dependent on intra-aortic balloon counter-pulsation for 7 days OR other temporary (indicated for 30 days use, or less) mechanical circulatory support (including ECMO) for 7 days, OR supported with IV inotropes for 7 days and failing to respond.
5. Age between 18 and 80 years.
6. BSA > 1.2 m2 and < 2.5 m2.
7. Informed Consent (approved by the IRB) signed by patient or legal representative.

Exclusion Criteria

Absolute Exclusion Criteria
1. History of cardiac transplantation or left ventricular reduction procedure.

2. Clinical conditions, other than heart failure, which could limit survival to less than three years AND / OR INTERMACS® Patient Profile 1 (the patient can have Modifiers A or TCS)

3. Cause of heart failure due to, or associated with, uncorrected thyroid disease, obstructive / restrictive cardiomyopathy, pericardial disease, amyloidosis, dermatomyositis, or active myocarditis.

4. Intolerance to anti-coagulation or anti-aggregation therapy required for post-operative therapy.

5. Known sensitivity to products of bovine origin. The Jarvik 2000 incorporates a Hemashield vascular graft. Patients with a known sensitivity to products of bovine origin should not be implanted.

6. Chronic immunosuppression.

7. Positive serum pregnancy test.

8. Confirmation by neurologist of impairment of cognitive function, presence of Alzheimer’s disease or any other form of irreversible dementia. AND / OR recent history of psychiatric disease (including drug or alcohol abuse) that is likely to impair compliance with study protocol.

9. Presence of mechanical circulatory support including right ventricular support (other than intra-aortic counterpulsation and temporary mechanical circulatory support indicated for 30 days use or less),

10. Mechanical respiration.

11. Extracorporeal Membane Oxygenator support for greater than 7 days, within 30 days of evaluation.

12. International normalized ratio (INR) > 1.4 or prothrombin time (PT) > 15 seconds within 24 hours, without anti-coagulation or anti-aggregation therapy, before randomization or history of unstable PT.

13. Acute ventricular septal defect OR moderate / severe aortic insufficiency, which are not corrected at the time of Study surgery.

14. Severe chronic obstructive pulmonary disease as evidenced by forced expiratory volume ≤ 1.5 L/min.

15. Presence of implanted mechanical aortic valve (unless replaced by a tissue valve at surgery).

16. Evidence of untreated abdominal aortic aneurysm greater than 5cm, determined by abdominal ultrasound within 60 days before enrollment.

17. Evidence of intrinsic hepatic disease defined as liver enzyme values (aspartate aminotransferase, alanine aminotransferase, or total bilirubin) > five times the upper limit of normal within 7 days before enrollment, or biopsy-proven cirrhosis.

18. History of cytotoxic or chemotherapeutic drugs affecting cell division or DNA synthesis within the past five years. This specifically excludes hormone therapy.

 

Participant Reimbursement

Absolute Exclusion Criteria1. History of cardiac transplantation or left ventricular reduction procedure.2. Clinical conditions, other than heart failure, which could limit survival to less than three years AND / OR INTERMACS® Patient Profile 1 (the patient can have Modifiers A or TCS).3. Cause of heart failure due to, or associated with, uncorrected thyroid disease, obstructive / restrictive cardiomyopathy, pericardial disease, amyloidosis, dermatomyositis, or active myocarditis.4. Intolerance to anti-coagulation or anti-aggregation therapy required for post-operative therapy.5. Known sensitivity to products of bovine origin. The Jarvik 2000 incorporates a Hemashield vascular graft. Patients with a known sensitivity to products of bovine origin should not be implanted.6. Chronic immunosuppression.7. Positive serum pregnancy test.8. Confirmation by neurologist of impairment of cognitive function, presence of Alzheimer’s disease or any other form of irreversible dementia. AND / OR recent history of psychiatric disease (including drug or alcohol abuse) that is likely to impair compliance with study protocol.9. Presence of mechanical circulatory support including right ventricular support (other than intra-aortic counterpulsation and temporary mechanical circulatory support indicated for 30 days use or less),10. Mechanical respiration.11. Extracorporeal Membane Oxygenator support for greater than 7 days, within 30 days of evaluation.12. International normalized ratio (INR) > 1.4 or prothrombin time (PT) > 15 seconds within 24 hours, without anti-coagulation or anti-aggregation therapy, before randomization or history of unstable PT.13. Acute ventricular septal defect OR moderate / severe aortic insufficiency, which are not corrected at the time of Study surgery.14. Severe chronic obstructive pulmonary disease as evidenced by forced expiratory volume ≤ 1.5 L/min.15. Presence of implanted mechanical aortic valve (unless replaced by a tissue valve at surgery).16. Evidence of untreated abdominal aortic aneurysm greater than 5cm, determined by abdominal ultrasound within 60 days before enrollment.17. Evidence of intrinsic hepatic disease defined as liver enzyme values (aspartate aminotransferase, alanine aminotransferase, or total bilirubin) > five times the upper limit of normal within 7 days before enrollment, or biopsy-proven cirrhosis.18. History of cytotoxic or chemotherapeutic drugs affecting cell division or DNA synthesis within the past five years. This specifically excludes hormone therapy.19. Occurrence of stroke within 60 days before enrollment or history of significant cerebrovascular disease characterized by recurrent TIAs or stroke.20. History of non-CNS thromboembolism within 60 days of enrollment, or presence of thrombus in the LV or LA.21. History of fixed pulmonary arterial hypertension with pulmonary vascular resistance measured as > 7 Wood units prior to enrollment.22. Serum creatinine ≥ 3.5 mg/dL or regimen of long-term dialysis.23. Suspected or active systemic infection 48 hours before enrollment.24. Platelet count < 50x103/mm3 within 24 hours before enrollment.25. HIV positive.26. Refusal of blood transfusion.27. Major peripheral vascular disease accompanied by pain on rest or leg ulceration.28. Severe calcification of both the ascending and/or descending thoracic aorta with no suitable calcium free position to place the outflow graft anastomosis.29. Other conflicting drug, biological, or device investigational studies that is likely to confound the study results.