Jarvik 2000 BTT Trial

Overview

Status: Recruiting
Keywords: LVAD , Heart Failure , Heart Transplantation , Destination Therapy , Bridge to Transplant , Bridge to Recovery , Artificial Heart
IRB Number: 00031307
Specialty: Cardiothoracic Surgery, Cardiothoracic Surgery
Sub Specialties: Heart Failure, Heart Transplant

Brief Summary

The Jarvik 2000 Heart is a silent, compact axial flow impeller pump that rotates at speeds of 8,000 to 12,000 rpm providing blood flow of up to six liters/minute. Similar to other left VADs (LVAD), this pump will support the failing left ventricle until a suitable heart can be transplanted into the patient. However, this device is much smaller in respect to the current FDA approved LVADs and is implanted into the apex of the left ventricle instead of attaching to the left ventricle via an inflow cannula like the other FDA approved devices. This device is also unlike the other LVADs in that it can be implanted using not only a mid-sternotomy incision, but also a left thoracotomy or subcostal approach.
 

In the CAP cohort, the safety and efficacy of the Jarvik 2000 Heart will be evaluated with respect to mechanical (device-related) and physiologic (patient-related) responses. All device-related and patient-related complications will be monitored. Rates of bleeding, hemolysis, thromboembolism, infection, and device malfunction are expected to be comparable to or lower than those of other systems. A detailed risk/benefit analysis will be completed, and the patients’ quality of life will be measured before, during, and after study participation.

The intent is to demonstrate that the Jarvik 2000 Heart can be used in patients with body surface area (BSA) ≥ 1.5 m2 to 2.3 m2 and that this system will yield a post transplant survival rate similar to that of other implantable VADs.
 

Detailed Description

The Jarvik 2000 Heart is a silent, compact axial flow impeller pump that rotates at speeds of 8,000 to 12,000 rpm providing blood flow of up to six liters/minute. Similar to other left VADs (LVAD), this pump will support the failing left ventricle until a suitable heart can be transplanted into the patient. However, this device is much smaller in respect to the current FDA approved LVADs and is implanted into the apex of the left ventricle instead of attaching to the left ventricle via an inflow cannula like the other FDA approved devices. This device is also unlike the other LVADs in that it can be implanted using not only a mid-sternotomy incision, but also a left thoracotomy or subcostal approach.

Principal Investigator: Craig Selzman
Department: Cardiothoracic Divison
Co Investigator:

Contact Information

Name:Erin Davis
Phone: 801-581-5834
Email: erin.davis@hsc.utah.edu

Inclusion Criteria

Inclusion Criteria
Category I
• Transplant listed UNOS status 1A or 1B patient.
• BSA ≥ 1.5 m2 to 2.3 m2.
• Pulmonary capillary wedge pressure of ≥ 18 mmHg, with a cardiac index of ≤ 2.0 L/min/m2 or systolic blood pressure of ≤ 80 mmHg.
• Dependent on one or more intravenous inotropic agents or an intraaortic balloon pump (IABP). Inotropic agents may include dopamine, dobutamine, milrinone, epinephrine, and digitalis.
Category II
• Transplant listed UNOS status 1A or 1B patient.
• Hospitalized
• Receiving inotropic or IABP support.
• Acute cardiac decompensation or cardiac arrest (systolic blood pressure ≤ 60 mmHg).
Candidates for either category must meet all of the inclusion criteria within 72 hours before pump implantation.
There are no differences in the target population for enrollment at the Salt Lake City VA and University populations.

Exclusion Criteria

Exclusion Criteria
• The Jarvik 2000 Heart incorporates a Hemashield Vascular Graft. This graft should not be implanted in patients with a known sensitivity to products of bovine origin.
• Cause of heart failure due to non-dilated cardiomyopathy and/or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, or active myocarditis.
• Renal failure necessitating hemodialysis for at least 7 days during the preceding 30 days.
• Chronic obstructive pulmonary disease, as documented by pulmonary function testing (FEV1 < 35% of the predicted normal value).
• Fixed pulmonary hypertension: PVR > 5 wood units with pulmonary vasodilator therapy.
• Right-sided heart failure: right ventricular EF < 10%, with PVR > 5 wood units.
• Acute ventricular septal defect.
• Sustained ventricular fibrillation or ventricular tachycardia necessitating standard advanced cardiac life support, including cardiac massage, and lasting for more than 1 hour.
• Presence of an artificial aortic valve.
• Severe (+3 to +4) aortic regurgitation.
• Evidence of intrinsic hepatic disease difined as liver enzyme values (AST, ALT, or total bilirubin) 3 times greater than the upper limit of normal within 4 days before enrollment, or biopsy-proven liver cirrhosis.
• Systemic infection: positive blood cultures and clinical signs of sepsis (WBC > 12,000 mm3, temperature > 38°C) that cannot be treated with appropriate antibiotic therapy because of resistant organisms.
• Severe blood dyscrasia: PT > 16 seconds; PTT > 45 seconds; platelet count of < 50,000 mm3 without anticoagulant or antiplatelet therapy.
• Malignancy not in remission.
• Peripheral vascular disease causing lower-extremity ischemic pain at rest and not treatable with surgery.
• Current participation in investigational trials with other devices, drugs or biologic agents with the exception of the Anginera patch used according to an FDA approved IND Phase 1 safety study.
• HIV positive status.
• Pregnancy.
• History of heparin-induced thrombocytopenia or other known coagulopathy.
• Refusal of blood transfusion.
• Severe calcification of the ascending or descending thoracic aorta.
• Patients who cannot be weaned from cardiopulmonary bypass after coronary artery bypass or valve surgery.
• Acute myocardial infarction.
Patients will be disqualified from this study if any of the above exclusion criteria are met during the previous 72 hour period before scheduled implant. If any of the exclusion criteria are subsequently resolved, the patient may become a suitable candidate if all the inclusion criteria are met.
There are no differences in the target population for enrollment at the Salt Lake City VA and University populations.