Jarvik 2000 Heart as a Bridge to Cardiac Transplantation - Pivotal Trial
Clinical Protocol for Evaluation of the Jarvik 2000 Heart Assist System
1 other identifier
interventional
150
1 country
1
Brief Summary
The purpose of the study is to determine the safety and effectiveness of the Jarvik 2000 Heart as a bridge to heart transplantation in end-stage heart failure patients who are approved heart transplant candidates.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 heart-failure
Started Apr 2005
Longer than P75 for phase_2 heart-failure
1 active site
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
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
December 26, 2007
CompletedFirst Posted
Study publicly available on registry
January 11, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedSeptember 27, 2013
September 1, 2013
7.1 years
December 26, 2007
September 20, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Survival to cardiac transplantation or survival and transplant listed at 180 days following implant of the Jarvik 2000 Heart.
180 days
Secondary Outcomes (1)
Incidence of serious adverse events as events per patient month including infection, stroke, VAD failure, and all serious adverse events. Quality of Life measures - MLHFQ, NYHA class, Neurocognitive assessments.
180 days
Study Arms (1)
Jarvik 2000 Ventricular Assist System
EXPERIMENTALJarvik 2000 Ventricular Assist System
Interventions
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.
Eligibility Criteria
You may qualify if:
- Transplant listed UNOS status IA or IB patients.
- BSA \>1.5 m2 and \<2.3 m2.
- Dependent on one or more intravenous inotropic agents or an intraaortic balloon pump (IABP).
You may not qualify if:
- Known risk factors or conditions that would contraindicate LVAD implantation or adversely affect patient survival.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
Related Publications (1)
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.
PMID: 35421002DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Robert Jarvik, MD
Jarvik Heart, Inc. SPONSOR
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 26, 2007
First Posted
January 11, 2008
Study Start
April 1, 2005
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
September 27, 2013
Record last verified: 2013-09