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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
HeartWare, Inc.
ClinicalTrials.gov Identifier:
NCT01166347
First received: July 16, 2010
Last updated: January 9, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Chronic Heart Failure
Device: HeartWare® VAS
Device: Control LVAD

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Controlled, Un-blinded, Multi-Center Clinical Trial to Evaluate the HeartWare® Ventricular Assist System (VAS) for Destination Therapy of Advanced Heart Failure

Resource links provided by NLM:


Further study details as provided by HeartWare, Inc.:

Primary Outcome Measures:
  • Stroke-free survival [ Time Frame: Two years ] [ Designated as safety issue: Yes ]
    The primary endpoint of the trial is stroke-free survival at two years, defined as alive on the originally implanted device, transplanted or explanted due to patient recovery. Secondary endpoints include adverse events such as bleeding and infection, as well as functional status, hospitalization, assessment of neuro-cognitive function and patient quality of life.


Secondary Outcome Measures:
  • Incidence of bleeding [ Time Frame: Two years ] [ Designated as safety issue: Yes ]
    Incidence of bleeding, per INTERMACS definition

  • Incidence of major infections [ Time Frame: Two years ] [ Designated as safety issue: Yes ]
    Incidence of major infections, per INTERMACS definition

  • Incidence of all device failures and device malfunctions [ Time Frame: Two years ] [ Designated as safety issue: Yes ]
    Incidence of all device failures and device malfunctions per INTERMACS definition

  • Time to death [ Time Frame: Two Years ] [ Designated as safety issue: Yes ]
  • Health Status improvement measured by KCCQ and EuroQol EQ-5D [ Time Frame: Two Years ] [ Designated as safety issue: No ]
    Health Status improvement as measured by Kansas City Cardiomyopathy Questionaire (KCCQ) and EuroQol EQ-5D.

  • Functional status improvement measured by (NYHA)class and 6-minute walk [ Time Frame: Two Years ] [ Designated as safety issue: No ]
    Functional status improvement, as measured by New York Heart Association (NYHA)class and 6-minute walk test.


Estimated Enrollment: 450
Study Start Date: August 2010
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HeartWare® VAS
Implant of HeartWare® Ventricular Assist System
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.
Active Comparator: Control LVAD
Implant of FDA-approved LVADs approved for destination therapy
Device: Control LVAD
Any FDA-approved LVAD for destination therapy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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) 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 < 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

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
  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 laboratory testing.
  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 (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 restrictive cardiomyopathy
  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
  25. Pregnancy
  26. Patient unwilling or unable to comply with study requirements
  27. Technical obstacles, which pose an inordinately high surgical risk, in the judgment of the investigator
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01166347

  Show 50 Study Locations
Sponsors and Collaborators
HeartWare, Inc.
Investigators
Principal Investigator: Francis Pagani, MD University of Michigan Hospital
Principal Investigator: Joseph Rogers, MD Duke University
  More Information

No publications provided

Responsible Party: HeartWare, Inc.
ClinicalTrials.gov Identifier: NCT01166347     History of Changes
Other Study ID Numbers: HW004
Study First Received: July 16, 2010
Last Updated: January 9, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 09, 2014