Transplant Center

Evaluation of the Levacor Ventricular Assist Device as a Bridge to Cardiac Transplantation

Study Description
The Levacor VAD is an advanced, next-generation rotary blood pump intended for adults who suffer from late-stage heart failure. Instead of mechanical or blood-lubricated bearings, the Levacor VAD™ is a compact, centrifugal pump with an impeller that is completely magnetically levitated. Full magnetic levitation has the potential to eliminate wear mechanisms during operation of the pump and permit greater clearances and more optimized blood flow around the impeller while eliminating dependence on the patient's blood for suspension.The Levacor VAD is being evaluated for safety and effectiveness in patients with with presumed non-reversible left ventricular failure for a bridge to heart transplantation. Success is defined as any one of the following: survival to cardiac transplantation prior to 180 days, survival on device to 180 days, device removal for recovery and survival to 60 days after device removal

Participant Eligibility
Inclusion Criteria:
•    Patient must be at least 18 years of age at the time of VAD implantation.
•    Listed for cardiac transplantation as UNOS Status 1A or 1B at the time of VAD implantation or within 72 hours of VAD implantation.
•    Body Surface Area (BSA) 1.2 m2 or greater.
•    If female of childbearing potential must have negative pregnancy test.
•    Patient has signed an Informed Consent.
Exclusion Criteria:
•    Unacceptable surgical risk according to Principal Investigator.
•    Intolerance or contraindication to anticoagulation or antiplatelet therapies
•    Excessive risk of bleeding as evidenced by INR > 2.3, or PTT > 45 sec, or platelet count < 50,000 U, unresponsive to treatment
•    Excessive neurologic risk documented as TIA within the last 3 months or stroke within the last 6 months
•    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.
•    Fixed pulmonary hypertension with a most recent PVR > 5 Wood units unresponsive to pharmacological intervention
•    Severe chronic obstructive pulmonary disease as evidenced by an FEV1 < 1.0 L or restrictive lung disease or prolonged (> 48 hours) intubation
•    Presence of mechanical aortic valve that will not be converted to a bioprosthesis during VAD implantation
•    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 persistent foramen ovale, atrial septal defect
•    Cardiogenic shock secondary to acute myocardial infarction
•    Presence of ongoing mechanical circulatory support other than intra-aortic balloon counterpulsation
•    Presence of uncontrolled infection
•    BMI > 40 kg/m2
•    Significant peripheral vascular disease accompanied by pain at rest, extremity ulceration or disabling claudication
•    Illness, other than heart disease, that would limit survival to less than 1 year
•    Pulmonary embolus < 2 weeks before VAD implant
•    Poor/compromising nutritional status in judgment of Principal Investigator
•    Participation in another clinical trial that, according to the Principal Investigator, is likely to affect the Study outcome or confound the results
How long does the study run?
Complete study enrollment and primary data collection may last approximately 2 years or until the trial is enrolled completely.

Location(s) of the Clinic Trial
About 160 patients are expected to participate in the study from as many as 40 hospitals throughout the United States. Please see www.clinictrials.gov for a complete list or talk to the study coordinator.

Contact Information
Status: Open to Enrollment
Name, Phone, Email:
Erin Davis, RN
801-585-3188
erin.davis@hsc.utah.edu
Principle Investigator:
Craig Selzman, M.D.
Please Note:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. For more specific questions regarding eligibility, a clinic visit may be needed to determine if you are eligible for this study. If you have specific questions regarding your condition which require clinical expertise, please call your primary care physician. If you do not have a primary care physician, we can help you find a University of Utah doctor or clinic location to meet your health care needs.
Although the studies described on this Web site may have potential benefits as described, the University of Utah and its physicians and affiliated hospitals cannot and do not guarantee or promise that you will receive any benefits from participating in a study.