Post- Approval Study on Patients Who Received a HeartWare HVAD® During IDE Trials
NCT ID: NCT01832610
Last Updated: 2019-07-11
Study Results
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View full resultsBasic Information
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COMPLETED
101 participants
OBSERVATIONAL
2013-01-31
2018-03-31
Brief Summary
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Detailed Description
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* Patients who are on continued HeartWare® System support, (original or exchange device)
* Patients who have been explanted for transplant or recovery and have not yet completed 6 months of follow-up
Patients who participated in prior trials who will not be approached to participate in this follow-up study include:
• Patients who have been explanted for transplant or recovery and have completed at least 6 months of follow-up (documented in the prior IDE trial).
No new patients are being screened or implanted with the HeartWare® System for this trial, it is a follow-up trial only.
Conditions
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Study Design
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CASE_ONLY
OTHER
Study Groups
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HeartWare® VAS
Ventricular Assist Device (HeartWare® VAS)
HeartWare® VAS
The HeartWare® LVAD is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device which is both lightweight and simple to use.
Interventions
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HeartWare® VAS
The HeartWare® LVAD is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device which is both lightweight and simple to use.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. The patient was implanted with the HeartWare® Ventricular Assist System and was an active patient in the prior trial.
3. The patient has signed informed consent for participation in the study.
Exclusion Criteria
2. The patient did not sign the informed consent.
18 Years
ALL
No
Sponsors
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Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Responsible Party
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Locations
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Stanford University School of Medicine
Stanford, California, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
University of Florida - Gainesville
Gainesville, Florida, United States
University of Miami / Jackson Memorial Hospital
Miami, Florida, United States
The Emory Clinic Inc.
Atlanta, Georgia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
IU Health Methodist
Indianapolis, Indiana, United States
Jewish Hospital - Rudd Heart and Lung Institute
Louisville, Kentucky, United States
Tufts Medical Center
Boston, Massachusetts, United States
University of Michigan Hospital
Ann Arbor, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Washington University / Barnes Jewish Hospital
St Louis, Missouri, United States
Montefiore Medical Center
The Bronx, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio State University Medical Center
Columbus, Ohio, United States
Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
University of Texas - South Western
Dallas, Texas, United States
Texas Heart Institute
Houston, Texas, United States
Northwest Cardiothoracic &Transplant Surgeons
Spokane, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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HW-PAS-03
Identifier Type: -
Identifier Source: org_study_id
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