VentrAssistTM LVAD as a Bridge to Cardiac Transplantation - Pivotal Trial
- Conditions
- End-stage Heart FailureCardiomyopathies
- Registration Number
- NCT00483197
- Lead Sponsor
- Ventracor
- Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of VentrAssistTM LVAD in individuals who are awaiting heart transplants.
- Detailed Description
LVADs are efficacious in improving survival and functional status when used as a bridge to transplantation. The purpose of this study is to evaluate the safety and effectiveness of the VentrAssist LVAD in providing circulatory support in individuals who are awaiting heart transplants.
The VentrAssist LVAD is a centrifugal flow pump. Its small size and mechanical simplicity offers benefits not available with currently approved LVADs, including facilitating a more limited implantation procedure, which could reduce surgical morbidity and mortality.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 140
(The following are general criteria; more specific criteria are included in the study protocol):
- Approved and listed for cardiac transplantation.
- Patient for whom LVAD implantation is planned as a clinically indicated bridge to cardiac transplantation.
(The following are general criteria; more specific criteria are included in the study protocol):
- Presence of heart conditions that would contraindicate LVAD implantation by adversely affecting patient survival or LVAD function.
- Primary coagulopathy or platelet disorder; contraindication to anticoagulant or anti-platelet agents.
- Presence of any mechanical circulatory support other than intra-aortic balloon pump.
- Therapy with an investigational intervention at the time of screening.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Survival to cardiac transplantation or to 180 days post implantation and listed for cardiac transplantation in categories UNOS 1A or 1B.
- Secondary Outcome Measures
Name Time Method Quality of life Functional status Neurocognitive function
Trial Locations
- Locations (28)
Northwestern University
🇺🇸Chicago, Illinois, United States
University of Maryland School of Medicine
🇺🇸Baltimore, Maryland, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
UPMC Presbyterian
🇺🇸Pittsburgh, Pennsylvania, United States
University of Alabama
🇺🇸Birmingham, Alabama, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Washington University School of Medicine
🇺🇸St. Louis, Missouri, United States
Fairfax (Inova) Hospital
🇺🇸Falls Church, Virginia, United States
Sacred Heart Medical Center
🇺🇸Spokane, Washington, United States
Columbia University
🇺🇸New York, New York, United States
Rochester Medical Center University
🇺🇸Rochester, New York, United States
University of Wisconsin Hospital
🇺🇸Madison, Wisconsin, United States
St. Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Jackson Memorial
🇺🇸Miami, Florida, United States
St. Vincent's
🇺🇸Indianapolis, Indiana, United States
University of Minnesota Medical Center
🇺🇸Minneapolis, Minnesota, United States
Duke Medical Center
🇺🇸Durham, North Carolina, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Methodist Hospital
🇺🇸Houston, Texas, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Mount Sinai Hospital
🇺🇸New York, New York, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
University of Washington
🇺🇸Seattle, Washington, United States
Newark Beth Israel Medical Center
🇺🇸Newark, New Jersey, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States