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



Status:Active, not recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:6/1/2018
Start Date:October 2013
End Date:August 2020

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

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.

The study will evaluate non-inferiority of neurologic injury incidence in a new cohort of
subjects receiving improved blood pressure management to a control group (i.e., any
FDA-approved LVAD for destination therapy). Secondary endpoints include: a comparison of
stroke/TIA incidence to a reference observed in the original IDE clinical trial (HW004) that
did not specify improved blood pressure management; and non-inferiority of stroke-free
success on the originally implanted device to the control group. 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 60 months post-implant.

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
study.

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
therapy).

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
ultrafiltration.

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
We found this trial at
47
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5121 S Cottonwood St
Murray, Utah 84157
(801) 507-7000
Intermountain Medical Center Intermountain Medical Center is one of the most technologically advanced and patient-friendly...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
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3500 Gaston Avenue
Dallas, Texas 75246
1.800.422.9567
Baylor University Medical Center Baylor University Medical Center in Dallas, TX is ranked nationally in...
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3300 Gallows Road
Falls Church, Virginia 22042
(703) 776-4001
Inova Fairfax Hospital Inova Fairfax Hospital, Inova's flagship hospital, is an 833-bed, nationally recognized regional...
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Gainesville, Florida 32611
(352) 392-3261
University of Florida Gainesville UF has a long history of established programs in international education,...
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Los Angeles, California 90033
213) 740-2311
University of Southern California The University of Southern California is one of the world’s leading...
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1611 Northwest 12th Avenue
Miami, Florida 33136
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
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201 Presidents Circle
Salt Lake City, Utah 84108
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University of Utah Research is a major component in the life of the U benefiting...
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291 Campus Dr
Stanford, California 94305
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Ann Arbor, Michigan 48109
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Atlanta, Georgia 30342
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Atlanta, Georgia 30322
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Baltimore, Maryland 20742
(301) 405-1000
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1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
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251 E Huron St
Chicago, Illinois 60611
(312) 926-2000
Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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Cleveland, Ohio 44195
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2799 W Grand Blvd
Detroit, Michigan 48202
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2301 Erwin Rd
Durham, North Carolina 27710
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Hershey, Pennsylvania 17033
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2900 W Oklahoma Ave
Milwaukee, Wisconsin 53215
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Minneapolis, Minnesota 55407
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New Orleans, Louisiana 70115
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Norfolk, Virginia 23507
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4440 West 95th Street
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Saint Louis, Missouri 63110
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1959 NE Pacific St
Seattle, Washington 98195
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110 Irving St NW
Washington, District of Columbia 20010
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