VentrAssistTM LVAD for the Treatment of Advanced Heart Failure - Destination Therapy
Evaluation of the VentrAssistTM Left Ventricular Assist Device for the Treatment of Advanced Heart Failure - Destination Therapy
1 other identifier
interventional
225
1 country
27
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of LVADs in providing long-term circulatory support for patients who have chronic stage D heart failure and are ineligible for a heart transplant. This is a multi-center, prospective, randomized, controlled clinical trial, which is comprised of two independent modules.
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
Longer than P75 for phase_3
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 20, 2007
CompletedFirst Posted
Study publicly available on registry
June 22, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedSeptember 9, 2009
September 1, 2009
June 20, 2007
September 4, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Module A: Survival without a disabling stroke.
Module B: A composite endpoint of disabling stroke-free survival without device replacement or repair due to failure of the device to provide adequate circulatory support.
Secondary Outcomes (1)
•Safety •Functional Status and Hospitalizations •Quality of Life and Neurocognitive Assessment
Interventions
Eligibility Criteria
You may qualify if:
- Eligible for either the VentrAssist or an FDA-approved DT LVAD
- LVEF \<=25%
- Stage D heart failure
- Ineligible for cardiac transplantation
- Treated with standard heart failure therapy
You may not qualify if:
- Contraindication to LVAD implantation
- Contraindication to anticoagulant or anti-platelet agents.
- Pre-existing mechanical circulatory support other than intra-aortic balloon pump
- Therapy with an investigational intervention at the time of screening
- A condition, other than heart failure, which would limit survival to less than 2 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
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, United States
Northwestern University
Chicago, Illinois, 60611, United States
St. Vincent's
Indianapolis, Indiana, 46260, United States
University of Maryland School of Medicine
Baltimore, Maryland, 21201, United States
University of Minnesota
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
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
University of Pittsburgh Medical Center
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
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 20, 2007
First Posted
June 22, 2007
Study Start
June 1, 2007
Study Completion
June 1, 2012
Last Updated
September 9, 2009
Record last verified: 2009-09