Status:
TERMINATED
Levacor™ Ventricular Assist Device (VAD) Bridge to Transplant Study
Lead Sponsor:
World Heart Corporation
Conditions:
Refractory Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The Levacor™ Ventricular Assist Device (VAD) has been designed for mechanical circulatory support in heart failure patients. The purpose of this clinical study is to determine its safety and efficacy ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01001793
Start Date
August 1 2009
End Date
July 1 2011
Last Update
December 23 2011
Active Locations (6)
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1
Tampa General Hospital
Tampa, Florida, United States, 33606
2
Jewish Hospital
Louisville, Kentucky, United States, 40202
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
4
INTEGRIS Baptist Medical Center
Oklahoma City, Oklahoma, United States, 73112