Jarvik 2000 Heart as a Bridge to Cardiac Transplantation - Pivotal Trial
NCT ID: NCT00591799
Last Updated: 2013-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
150 participants
INTERVENTIONAL
2005-04-30
2012-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Jarvik 2000 Ventricular Assist System
Jarvik 2000 Ventricular Assist System
The Jarvik 2000 Ventricular Assist System
Jarvik 2000 Heart implantation is intended for patient's with end-stage heart failure who are approved heart transplant candidates - who meet all of the study's inclusion criteria and none of its exclusion criteria.
Interventions
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The Jarvik 2000 Ventricular Assist System
Jarvik 2000 Heart implantation is intended for patient's with end-stage heart failure who are approved heart transplant candidates - who meet all of the study's inclusion criteria and none of its exclusion criteria.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* BSA \>1.5 m2 and \<2.3 m2.
* Dependent on one or more intravenous inotropic agents or an intraaortic balloon pump (IABP).
Exclusion Criteria
* Evidence of end organ dysfunction.
* Known coagulopathy or contraindication of anticoagulation or antiplatelet agents.
* Systemic infection.
* Malignancies not in remission.
* Current participation in investigational trials with other devices, drugs, or biologic agents.
18 Years
ALL
No
Sponsors
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Jarvik Heart, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Jarvik, MD
Role: STUDY_CHAIR
Jarvik Heart, Inc. SPONSOR
Locations
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University of Maryland Medical Center
Baltimore, Maryland, United States
Countries
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References
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Selzman CH, Feller ED, Walker JC, Sheridan BC, Silvestry SC, Daly RC, Anyanwu AC, Madigan D, Liu PY, Frazier OH, Jorde UP, Griffith BP. The Jarvik 2000 Left Ventricular Assist Device: Results of the United States Bridge to Transplant Trial. ASAIO J. 2023 Feb 1;69(2):174-182. doi: 10.1097/MAT.0000000000001750. Epub 2022 Apr 13.
Other Identifiers
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G000058
Identifier Type: -
Identifier Source: org_study_id