The Left Ventricular Assist Device (LVAD) Off or On Pump Implantation Study
Purpose
The purpose of this study is to compare adverse events after off-pump LVAD surgery or on-pump LVAD surgery.
Conditions
- Heart Failure
- LVAD
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Off-Pump |
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Active Comparator On-Pump |
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More Details
- Status
- Terminated
- Sponsor
- The University of Texas Health Science Center, Houston