The Left Ventricular Assist Device (LVAD) Off or On Pump Implantation Study (LVAD-ON-OFF)

This is an interventional treatment trial for Heart Failure focused on measuring LVAD Read More

Inclusion Criteria:

• The patient has had a diagnosis of end stage heart failure, New York Heart association (NYHA) class III or IV HF for a minimum of 90 days prior to screening.
• The patient has guideline-directed medical therapy according to American College of Cardiology(ACC)/American Heart Association (AHA)/European Society of Cardiology(ESC) heart failure(HF) guidelines
• The patient has an Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) score of 1-3.
• Left ventricular assist device (LVAD) placement is intended as a bridge to transplant (BTT) or destination therapy (DT) with either HeartWare Ventricular Assist Device (HVAD) or HeartMate III LVAD.
• The patient is able to sign informed consent form and Release of Medical Information Form.
• The patients is willing and able to participate in scheduled follow-up appointments.

Exclusion Criteria:

• The patient requires concomitant surgery for left ventricular or atrial appendage closure or the patient has severe aortic insufficiency, mitral stenosis, or severe tricuspid regurgitation.
• The patient has an intracardiac thrombus or other mass diagnosed by echocardiography, left ventriculogram, or other imaging.
• Planned insertion of right ventricular(RV) support device (either temporary or permanent).
• The patient has suffered an acute cardiovascular event such as acute coronary syndrome (ST elevation myocardial infarction (STEMI) or Non-ST elevation myocardial infarction (NSTEMI), or unstable angina, or underwent any cardiac surgery or interventional cardiac or peripheral vascular procedure within 30 days prior to LVAD implantation.
• The patient has had ischemic or hemorrhagic stroke as diagnosed by CT or MRI within 90 days prior to study enrollment.
• The patient had prior heart or other organ transplantation, or surgically implanted LVAD or cardiac shunt.
• The patient will likely need an immediate heart transplant due to hemodynamic instability.
• The patient has had a known active malignancy or treatment for cancer within the past year except for localized prostate cancer, cervical carcinoma in situ, breast cancer in situ, or non-melanoma skin cancer that has been definitively treated.
• The patient has history of any malignancy where expected survival is less than two years. Past medical history of cancer is not exclusionary as long as subject has been disease-free for at least one years since the time of diagnosis and treatment.
• Patient has a severe co-morbidity (current need for hemodialysis or current glomerular filtration rate(GFR) ≤20 mL/minute/1.73 m2 estimated by Modification of Diet in Renal Disease( MDRD)calculation; hepatic impairment defined as liver function tests [alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP)] >3x Upper Limit of Normal within 30 days prior to LVAD implantation or known objectively confirmed intrinsic liver disease (e.g., cirrhosis, chronic hepatitis B or hepatitis C virus infection)).
• The patient has a known bleeding diathesis or thrombocytopenia defined as platelet count <50,000 platelets/μL.
• The patient has peri/postpartum cardiomyopathy, or is a pregnant or lactating woman, or a woman of child-bearing age not using a suitable method of contraception.
• The patient, who in the absence of an Implantable Cardioverter Defibrillator (ICD) (or any implanted device capable of defibrillation), has a history of malignant ventricular arrhythmia or sustained ventricular tachycardia (VT), with sustained VT demonstrated by Q wave R wave S wave (QRS) complexes wider than 120 milliseconds, lasting more than 30 seconds, and with a rate of more than 100 beats per minute on screening ECG or other data supporting this diagnosis.
• Recent history of psychiatric disease, including drug or alcohol abuse, that is likely to impair, in the opinion of the investigator, the subject's ability to comply with protocol-mandated procedures.
• Participation in any other clinical investigation that is likely to confound study results or affect study outcome