Jarvik 2000 DT Trial
|Principal Investigator: CraigSelzman|
|Keywords: Heart Failure , LVAD , Artificial Heart , Heart Surgery||Department: Cardiothoracic Divison|
|IRB Number: 00060024||Co Investigator: StavrosDrakos|
|Specialty: Cardiology, Cardiothoracic Surgery, Cardiothoracic Surgery|
|Sub Specialties: Heart Failure, Cardiac Mechanical Support, Heart Failure|
This study is designed to evaluate the safety and effectiveness of the Jarvik 2000® Left Ventricular Assist System (LVAS) with Post-Auricular Connector (behind the ear driveline), in patients with New York Heart Association Class IIIb and IV end-stage left ventricular failure, who are ineligible for heart transplantation and have demonstrated intolerance to optimal medical therapy for at least 45 of the last 60 days.
The principle purpose of this Study is to determine the percentage of patients in whom Destination Therapy (DT), not candidates for heart transplant, with the Jarvik 2000 LVAS with Post-Auricular Connector permits survival for two years with a Modified Rankin Score of 3 or less at the two-year follow-up, without repair or replacement of the implanted device, and to compare the outcome to a randomized control device.
A second purpose of the Study is to determine if the Jarvik 2000 LVAS with Post-Auricular Connector provides additional protection from serious adverse infection over a three-year follow-up period.
The multi-center study will be prospective, dual-armed, non-blinded (open-label) and randomized, comparing a treatment group receiving the Jarvik 2000 LVAS with Post-Auricular Connector to an active control group treated with the PMA approved Thoratec HeartMate® II LVAS for DT at a ratio of 2:1 randomization.
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.
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.