Keywords:LVAD , Heart Failure , Bridge to Transplant , Artificial heart
The Levacor Ventricular Assist Device (VAD) has been designed for mechanical circulatory support in heart failure patients. This trial is to determine its safety and efficacy as a bridge to transplant (BTT) in cardiac transplant candidates with presumed non-reversible left ventricular failure. The study duration is estimated to last approximately 2.5 years, with nominally 160 patients enrolled at up to 40 centers.
Principle Investigator: Craig Selzman
Principle Department: Cardiothoracic Divison
1. Patient must be at least 18 years of age at the time of VAD implantation.
2. Listed for cardiac transplantation as UNOS Status 1A or 1B at the time of VAD implantation or within 72 hours of VAD implantation.
3. Body Surface Area (BSA) 1.2 m2.
4. If female of childbearing potential must have negative pregnancy test.
5. Patient or legal representative has signed an Informed Consent.
1. Unacceptable surgical risk according to Principal Investigator.
2. Intolerance or contraindication to anticoagulation or antiplatelet therapies.
3. Excessive risk of bleeding as evidenced by INR > 2.3, or PTT > 45 sec, or platelet count < 50,000 U, unresponsive to treatment.
4. Excessive neurologic risk documented as TIA within the last 3 months or stroke within the last 6 months.
5. Evidence of any of the following indicators of end-organ dysfunction: total bilirubin > 4 mg/dL, ALT/AST > 3 times upper limit normal, serum creatinine >3.5 mg/dL.
6. Fixed pulmonary hypertension with a most recent PVR > 5 Wood units unresponsive to pharmacological intervention.
7. Severe chronic obstructive pulmonary disease as evidenced by an FEV1 < 1.0 L or restrictive lung disease or prolonged (> 48 hours) intubation.
8. Presence of mechanical aortic valve that will not be converted to a bioprosthesis during VAD implantation.
9. Planned concomitant surgical procedures other than aortic valve repair or tissue valve placement to treat moderate to severe aortic insufficiency, tricuspid valve repair, mitral valve repair, critical lesion CABG, LV thrombectomy (apical), closure of persistant foramen ovale, atrial septal defect.
10. Cardiogenic shock secondary to acute myocardial infarction.
11. Presence of ongoing mechanical circulatory support other than intra-aortic balloon counterpulsation.
12. Presence of uncontrolled infection.
13. BMI > 40 kg/m2.
14. Significant peripheral vascular disease accompanied by pain at rest, extremity ulceration or disabling claudication.
15. Illness, other than heart disease, that would limit survival to less than 1 year.
16. Pulmonary embolus < 2 weeks before VAD implant.
17. Poor/compromising nutritional status in judgment of Principal Investigator.
18. Participation in another clinical trial that, according to the Principal Investigator, is likely to affect the Study outcome or confound the results.
19. Those with psychiatric illness or a social situation that precludes adequate management of the pump.
20. Those with prior therapeutic radiation to the chest.
21. Those with history of multiple strokes.