A Clinical Trial to Evaluate the HeartWare™ Ventricular Assist System (ENDURANCE SUPPLEMENTAL TRIAL)

Not Recruiting

Trial ID: NCT01966458


This is a prospective, randomized, controlled, unblinded, multi-center evaluation of safety and efficacy in patients implanted with a HeartWare® HVAD who receive improved blood pressure management. Subjects have chronic Stage D or NYHA Class IIIB/IV left ventricular failure who have received and failed optimal medical therapy, and who are ineligible for cardiac transplantation.

Official Title

A Prospective, Randomized, Controlled, Unblinded, Multi-Center Clinical Trial to Evaluate the HeartWare™ Ventricular Assist Device System for Destination Therapy of Advanced Heart Failure

Stanford Investigator(s)


Inclusion Criteria:

   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

Exclusion Criteria:

   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
   health status.

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
   restrictive cardiomyopathy

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

26. Pregnancy

27. Patient unwilling or unable to comply with study requirements

28. Technical obstacles, which pose an inordinately high surgical risk, in the judgment of
   the investigator


device: Control LVAD

device: HeartWare® VAS (HVAD)

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Ian Rogers
(650) 723-8138