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Levacor™ Ventricular Assist Device (VAD) Bridge to Transplant Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01001793
Recruitment Status : Terminated (Commercial considerations relating to required device modifications.)
First Posted : October 27, 2009
Last Update Posted : December 23, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
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 as a bridge to transplant (BTT) in cardiac transplant candidates with presumed non-reversible left ventricular failure.

Condition or disease Intervention/treatment
Refractory Heart Failure Device: Levacor Ventricular Assist Device

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Levacor™ Ventricular Assist Device as a Bridge to Cardiac Transplantation
Study Start Date : August 2009
Primary Completion Date : July 2011
Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Device: Levacor Ventricular Assist Device
    Surgical procedure

Outcome Measures

Primary Outcome Measures :
  1. 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 [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Survival to transplant [ Time Frame: 6 months ]
  2. Survival 30 days post-transplant [ Time Frame: 6 months ]
  3. Survival while on device [ Time Frame: 6 months ]
  4. Incidence of adverse events while on device [ Time Frame: 6 months ]
  5. Device reliability [ Time Frame: 6 months ]
  6. Reoperations [ Time Frame: 6 months ]
  7. Functional status [ Time Frame: 6 months ]
  8. Quality of life [ Time Frame: 6 months ]
  9. Neurocognitive evaluation [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  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 or greater.
  4. If female of childbearing potential must have negative pregnancy test.
  5. Patient has signed an Informed Consent.

Exclusion Criteria:

  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 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01001793


Locations
United States, Florida
Tampa General Hospital
Tampa, Florida, United States, 33606
United States, Kentucky
Jewish Hospital
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Oklahoma
INTEGRIS Baptist Medical Center
Oklahoma City, Oklahoma, United States, 73112
United States, Utah
University of Utah Hospital
Salt Lake City, Utah, United States, 84132
United States, Virginia
Inova Fairfax Hospital/Inova Heart & Vascular Institute
Falls Church, Virginia, United States, 22042
Sponsors and Collaborators
World Heart Corporation
More Information

Responsible Party: World Heart Corporation
ClinicalTrials.gov Identifier: NCT01001793     History of Changes
Other Study ID Numbers: LEV01
First Posted: October 27, 2009    Key Record Dates
Last Update Posted: December 23, 2011
Last Verified: September 2011

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases