Status:
TERMINATED
Evaluation of the Safety and Effectiveness of the DuraHeart™ LVAS
Lead Sponsor:
Terumo Heart Inc.
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Specific Aims The aims of this trial are to evaluate the safety and effectiveness of the DuraHeart™ LVAS in patients with advanced heart failure who require LVAS support as a bridge to cardiac transpl...
Eligibility Criteria
Inclusion
- The following are general criteria; more specific conditions are included in the study protocol:
- Approved for cardiac transplantation
- Listed with UNOS on the Status 1 list
- Patient for whom LVAS implantation is planned as a clinically indicated bridge to cardiac transplantation
Exclusion
- The following are general criteria; more specific conditions are included in the study protocol:
- Contraindication to the administration of warfarin or anti-platelet agents
- Primary coagulopathy or platelet disorder
- Acute myocardial infarction within 48 hours prior to enrollment
- Anticipated need for RVAD support or ECMO at the time of LVAS implantation
- Prior cardiac transplantation, left ventricular reduction surgery, cardiomyoplasty, passive restraint device (i.e., CorCapTM Cardiac Support Device) or surgically implanted left ventricular assist device
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 12 2018
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00710567
Start Date
July 1 2008
End Date
November 12 2018
Last Update
December 13 2019
Active Locations (26)
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1
University of Alabama
Birmingham, Alabama, United States, 35294
2
Mayo Clinic - Phoenix
Phoenix, Arizona, United States, 85054
3
University of Arizona Medical Center
Tucson, Arizona, United States, 85724
4
University of Southern California
Los Angeles, California, United States, 90033