Trial Search Results
A Clinical Trial to Evaluate the HeartWare® Ventricular Assist System (ENDURANCE SUPPLEMENTAL TRIAL)
This is a prospective, randomized, controlled, unblinded, multi-center evaluation of the stroke incidence in patients implanted with a HeartWare® HVAD who receive optimal blood pressure management. The study compares results of stroke incidence in a new cohort of subjects receiving optimal blood pressure management to a reference stroke incidence observed in the original IDE clinical trial (HW004) that did not specify optimal blood pressure management. In addition, a secondary endpoint will evaluate non-inferiority of stroke-free success on the originally implanted device to a control group (i.e. any FDA-approved LVAD for destination therapy). Subjects will be randomized to HeartWare® HVAD or control LVAD in a 2:1 ratio. Each subject receiving the HeartWare® HVAD or control LVAD is followed to the primary and secondary endpoints at 12 months, with a subsequent follow-up period extending to 5 years post implant.
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)a. 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 b. 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 ≤ 25%
5. LVAD implant is intended as destination therapy
6. Must be able to receive either the HeartWare® HVAD or control LVAD
7. Patient must agree to participate in and comply with an improved blood pressure
management program, including maintenance of a patient diary.
8. Female patients of childbearing potential must agree to use adequate contraceptive
precautions (defined as oral contraceptives, intrauterine devices, surgical
contraceptives or a combination of condom and spermicide) for the duration of the
9. 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 as diagnosed by ST or T wave
changes on the ECG, diagnostic biomarkers, ongoing pain and hemodynamic abnormalities
as described (Figure 2) in the guidelines published in ACC/AHA 2007 Guidelines for the
Management of Patients with Unstable Angina/Non-ST-Elevation Myocardial Infarction ;.
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 as documented by computed
tomography (CT) scan or nuclear scan.
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)
at the time of screening/randomization or right atrial pressure > 20 mmHg on multiple
inotropes or right ventricular ejection fraction (RVEF) <15% with clinical signs of
severe right heart failure (e.g. Lower extremity edema, ascites or pleural effusions
refractory to treatment with diuretics and two inotropic drugs).
13. Active, uncontrolled infection diagnosed by a combination of clinical symptoms and
laboratory testing, including but not limited to, continued positive cultures,
elevated temperature and white blood cell (WBC) count, hypotension, tachycardia,
generalized malaise despite appropriate antibiotic, antiviral or antifungal treatment.
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 or
17. Specific liver enzymes [AST (SGOT) and ALT (SGPT] > 3 times upper limit of normal
within 72 hours of randomization.
18. A total bilirubin > 3 mg/dl within 72 hours of randomization, or biopsy proven liver
cirrhosis or portal hypertension.
19. Pulmonary vascular resistance is demonstrated to be unresponsive to pharmacological
manipulation and the PVR > 6 Wood units.
20. Patients with a mechanical heart valve.
21. Etiology of heart failure is due to, or associated with, uncorrected thyroid disease,
obstructive cardiomyopathy, pericardial disease, amyloidosis, active myocarditis or
22. History of severe COPD or severe restrictive lung disease (e.g. FEV1 <50%)
23. Participation in any other study involving investigational drugs or devices
24. Severe illness, other than heart disease, which would limit survival to < 3 years
25. Peripheral vascular disease with rest pain or ischemic ulcers of the extremities
27. Patient unwilling or unable to comply with study requirements
28. 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