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

NCT01001793 | Terminated DMC

• 1 other identifier: LEV01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 6

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.

Conditions

Refractory Heart Failure

Outcome Measures

Primary Outcomes (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

  6 months

Secondary Outcomes (9)

• Survival to transplant

  6 months

• Survival 30 days post-transplant

  6 months

• Survival while on device

  6 months

• Incidence of adverse events while on device

  6 months

• Device reliability

  6 months

Interventions

Levacor Ventricular Assist Device DEVICE

Surgical procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• World Heart Corporation: lead

Study Sites (6)

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Jewish Hospital

Louisville, Kentucky, 40202, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

INTEGRIS Baptist Medical Center

Oklahoma City, Oklahoma, 73112, United States

Location

University of Utah Hospital

Salt Lake City, Utah, 84132, United States

Location

Inova Fairfax Hospital/Inova Heart & Vascular Institute

Falls Church, Virginia, 22042, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2009
• First Posted: October 27, 2009
• Study Start: August 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: December 23, 2011

Record last verified: 2011-09

Locations

US (6)