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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by HeartWare, Inc.
Sponsor:
Information provided by (Responsible Party):
HeartWare, Inc.
ClinicalTrials.gov Identifier:
NCT01966458
First received: October 17, 2013
Last updated: November 19, 2014
Last verified: November 2014

October 17, 2013
November 19, 2014
October 2013
October 2016   (final data collection date for primary outcome measure)
Change in stroke incidence at 12 months on the originally implanted HVAD in a new cohort of subjects receiving optimal blood pressure management. [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01966458 on ClinicalTrials.gov Archive Site
Stroke Free Success [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Clinical Trial to Evaluate the HeartWare® Ventricular Assist System (ENDURANCE SUPPLEMENTAL TRIAL)
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 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).

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Heart Failure
  • Device: HeartWare® VAS
    The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.
  • Device: Control LVAD
    Any FDA-approved LVAD for destination therapy.
  • Experimental: HeartWare® VAS
    Implant of HeartWare® Ventricular Assist System
    Intervention: Device: HeartWare® VAS
  • Active Comparator: Control LVAD
    Implant of FDA-approved LVAD approved for destination therapy
    Intervention: Device: Control LVAD
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
429
Not Provided
October 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Dawn Dyer ddyer@heartware.com
United States
 
NCT01966458
HW004-A
Yes
HeartWare, Inc.
HeartWare, Inc.
Not Provided
Principal Investigator: Francis Pagani, MD University of Michigan Hospital
Principal Investigator: Joseph Rogers, MD Duke University
HeartWare, Inc.
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP