A Clinical Trial to Evaluate the HeartWare® Ventricular Assist System
Trial ID or NCT#
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.
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
- 1. Must be ≥18 years of age at consent
- 2. Body Surface Area (BSA) ≥ 1.2 m2
- 3. Patients with advanced heart failure symptoms (New York Heart Association (NYHA) 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 NYHA Class III or NYHA 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
- 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. 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 (PVR) 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 Chronic Obstructive Pulmonary Disease (COPD) or severe restrictive lung disease
- 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
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