Transplant Center

Jarvik 2000 Heart as a Bridge to Cardiac Transplantation - Pivotal Trial

Study Description
The Jarvik 2000 is a small (90 grams) continuous flow LVAD and is different from other LVADs in that it is implanted inside the left ventricle of the heart. The Jarvik 2000 Heart Assist System is being evaluated for safety and effectiveness in patients with end-stage heart failure for a bridge to heart transplantation. The primary endpoint of the trial is survival to cardiac transplantation or survival and transplant listed at 180 days following implant.

Participant Eligibility
Inclusion Criteria: (The following are general criteria; contact the study coordinator for more specific criteria):
•    18 Years and older Male or Female
•    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).
Exclusion Criteria: (The following are general criteria; contact the study coordinator for more specific criteria):
•    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.
How long does the study run?
The duration of this trial is 4 years or until it is fully enrolled.

Location(s) of the Clinic Trial
There are over 15 sites throughout the United States currently participating in this trial. Please see www.clinictrials.gov for a complete list or talk to the study coordinator.

Contact Information
Status: Open to Enrollment
Name, Phone, Email:
Erin Davis, RN
801-585-3188
erin.davis@hsc.utah.edu
Principle Investigator:
Craig Selzman, M.D.
Please Note:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. For more specific questions regarding eligibility, a clinic visit may be needed to determine if you are eligible for this study. If you have specific questions regarding your condition which require clinical expertise, please call your primary care physician. If you do not have a primary care physician, we can help you find a University of Utah doctor or clinic location to meet your health care needs.
Although the studies described on this Web site may have potential benefits as described, the University of Utah and its physicians and affiliated hospitals cannot and do not guarantee or promise that you will receive any benefits from participating in a study.