Trial Search Results
A Prospective, Randomized, Controlled, Un-blinded, Multi-Center Clinical Trial to Evaluate the HeartWare® Ventricular Assist System for Destination Therapy of Advanced Heart Failure
The purpose of this study is to determine the safety and effectiveness of the HeartWare Ventricular Assist System in patients with chronic Stage D/NYHA Class IIIB/IV left ventricular failure who have received and failed optimal medical therapy, and who are ineligible for cardiac transplantation.
Stanford is currently not accepting patients for this trial.
- Device: HeartWare® VAS
- Device: Control LVAD
1. Must be ≥18 years of age at consent
2. Body Surface Area (BSA) ≥ 1.2 m2
3. Patients with advanced heart failure symptoms (Class IIIB or IV) who are: (patient
must meet one of the following) 3a. On optimal medical management, including dietary
salt restriction and diuretics, for at least 45 out of the last 60 days and are
failing to respond; or 3b. In Class III or Class IV heart failure for at least 14
days, and dependent on intra aortic balloon pump (IABP) for 7 days and/or inotropes
for at least 14 days
4. Left ventricular ejection fraction (less than or equal to) 25%
5. LVAD implant is intended as destination therapy
6. Must be able to receive either the HeartWare® VAS or control LVAD
7. Female patients of childbearing potential must agree to use adequate contraceptive
precautions for the duration of the study.
8. The patient or legally authorized representative has signed the informed consent form
1. Body Mass Index (BMI) > 40
2. Existence of any ongoing mechanical circulatory support (MCS) other than an
intra-aortic balloon pump (IABP)
3. Prior cardiac transplant.
4. History of confirmed, untreated abdominal or thoracic aortic aneurysm > 5 cm.
5. Cardiothoracic surgery within 30 days of randomization.
6. Acute myocardial infarction within 14 days of implant
7. Patients eligible for cardiac transplantation
8. On ventilator support for > 72 hours within the four days immediately prior to
randomization and implant.
9. Pulmonary embolus within three weeks of randomization
10. Symptomatic cerebrovascular disease, stroke within 180 days of randomization or > 80%
stenosis of carotid or cranial vessels.
11. Uncorrected moderate to severe aortic insufficiency. Correction may include repair or
bioprosthesis at the time of implant.
12. Severe right ventricular failure as defined by the anticipated need for right
ventricular assist device (RVAD) support or extracorporeal membrane oxygenation (ECMO)
or right atrial pressure > 20 mmHg on multiple inotropes, right ventricular ejection
fraction (RVEF) <15% or clinical signs
13. Active, uncontrolled infection diagnosed by a combination of clinical symptoms and
14. Uncorrected thrombocytopenia or generalized coagulopathy (e.g., platelet count <
75,000, INR > 2.0 or PTT > 2.5 times control in the absence of anticoagulation
15. Intolerance to anticoagulant or antiplatelet therapies or any other peri- or
postoperative therapy that the investigator may administer based upon the patient's
16. Serum creatinine > 3.0 mg/dL within 72 hours of randomization or requiring dialysis
(does not include use of ultra-filtration for fluid removal).
17. All three liver enzymes [AST (SGOT), ALT (SGPT), or LDH] > 3 times upper limit of
normal or a total bilirubin > 3 mg/dl within 72 hours of randomization, or biopsy
proven liver cirrhosis or portal hypertension.
18. Pulmonary vascular resistance is demonstrated to be unresponsive to pharmacological
manipulation and the PVR > 6 Wood units.
19. Patients with a mechanical heart valve .
20. Etiology of heart failure is due to, or associated with, uncorrected thyroid disease,
obstructive cardiomyopathy, pericardial disease, amyloidosis, active myocarditis or
21. History of severe COPD or severe restrictive lung disease
22. Participation in any other study involving investigational drugs or devices
23. Severe illness, other than heart disease, which would limit survival to < 3 years
24. Peripheral vascular disease with rest pain or ischemic ulcers of the extremities
26. Patient unwilling or unable to comply with study requirements
27. Technical obstacles, which pose an inordinately high surgical risk, in the judgment of
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study