VentrAssistTM LVAD as a Bridge to Cardiac Transplantation - Pivotal Trial
Evaluation of the VentrAssistTM Left Ventricular Assist Device as a Bridge to Cardiac Transplantation - Pivotal Trial
1 other identifier
interventional
140
1 country
29
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of VentrAssistTM LVAD in individuals who are awaiting heart transplants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2007
Typical duration for phase_3
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 4, 2007
CompletedFirst Posted
Study publicly available on registry
June 6, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedSeptember 9, 2009
September 1, 2009
June 4, 2007
September 4, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Survival to cardiac transplantation or to 180 days post implantation and listed for cardiac transplantation in categories UNOS 1A or 1B.
Secondary Outcomes (3)
Quality of life
Functional status
Neurocognitive function
Interventions
Eligibility Criteria
You may qualify if:
- Approved and listed for cardiac transplantation.
- Patient for whom LVAD implantation is planned as a clinically indicated bridge to cardiac transplantation.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
University of Alabama
Birmingham, Alabama, 35294, United States
Mayo Clinic
Phoenix, Arizona, 85054, United States
University of Florida
Gainesville, Florida, 32610, United States
Jackson Memorial
Miami, Florida, 33136, United States
Northwestern University
Chicago, Illinois, 60611, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
St. Vincent's
Indianapolis, Indiana, 46260, United States
University of Maryland School of Medicine
Baltimore, Maryland, 21201, United States
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455, United States
Mayo Clinic
Rochester, Minnesota, 55904, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112, United States
Mount Sinai Hospital
New York, New York, 10029, United States
Columbia University
New York, New York, 10032, United States
Rochester Medical Center University
Rochester, New York, 14642, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Duke Medical Center
Durham, North Carolina, 27710, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Ohio State University
Columbus, Ohio, 43210, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213, United States
Methodist Hospital
Houston, Texas, 77030, United States
University of Utah
Salt Lake City, Utah, 84132, United States
Fairfax (Inova) Hospital
Falls Church, Virginia, 22042, United States
University of Washington
Seattle, Washington, 98185, United States
Sacred Heart Medical Center
Spokane, Washington, 99204, United States
University of Wisconsin Hospital
Madison, Wisconsin, 53792, United States
St. Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 4, 2007
First Posted
June 6, 2007
Study Start
June 1, 2007
Study Completion
June 1, 2010
Last Updated
September 9, 2009
Record last verified: 2009-09