This trial is active, not recruiting.

Condition chronic heart failure
Treatments heartware® vas, control lvad
Sponsor HeartWare, Inc.
Start date August 2010
End date May 2014
Trial size 450 participants
Trial identifier NCT01166347, HW004


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Implant of HeartWare® Ventricular Assist System
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)
Implant of FDA-approved LVADs approved for destination therapy
control lvad
Any FDA-approved LVAD for destination therapy.

Primary Outcomes

Stroke-free survival
time frame: Two years

Secondary Outcomes

Incidence of bleeding
time frame: Two years
Incidence of major infections
time frame: Two years
Incidence of all device failures and device malfunctions
time frame: Two years
Time to death
time frame: Two Years
Health Status improvement measured by KCCQ and EuroQol EQ-5D
time frame: Two Years
Functional status improvement measured by (NYHA)class and 6-minute walk
time frame: Two Years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Principal investigator Francis Pagani, MD
Trial information was received from ClinicalTrials.gov and was last updated in February 2015.
Information provided to ClinicalTrials.gov by HeartWare, Inc..