Levacor™ Ventricular Assist Device (VAD) Bridge to Transplant Study
NCT ID: NCT01001793
Last Updated: 2011-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
15 participants
INTERVENTIONAL
2009-08-31
2011-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Levacor Ventricular Assist Device
Surgical procedure
Eligibility Criteria
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Inclusion Criteria
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 or greater.
4. If female of childbearing potential must have negative pregnancy test.
5. Patient has signed an Informed Consent.
Exclusion Criteria
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 persistent 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.
18 Years
ALL
No
Sponsors
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World Heart Corporation
INDUSTRY
Responsible Party
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Locations
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Tampa General Hospital
Tampa, Florida, United States
Jewish Hospital
Louisville, Kentucky, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
INTEGRIS Baptist Medical Center
Oklahoma City, Oklahoma, United States
University of Utah Hospital
Salt Lake City, Utah, United States
Inova Fairfax Hospital/Inova Heart & Vascular Institute
Falls Church, Virginia, United States
Countries
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Other Identifiers
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LEV01
Identifier Type: -
Identifier Source: org_study_id