Evaluation of the Safety and Effectiveness of the DuraHeart™ LVAS



Status:Terminated
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:3/21/2019
Start Date:July 2008
End Date:November 12, 2018

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Evaluation of the Safety and Effectiveness of the DuraHeart™ Left Ventricular Assist System in Patients Awaiting Transplantation

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 transplantation.

Study Population The patient population for this trial consists of patients with end stage
heart failure awaiting cardiac transplantation. Patients must be listed for transplant with
UNOS with status 1A or 1B. All patients who meet the eligibility criteria may be included in
the study regardless of gender, race or ethnicity.

Study Design This is a multi-center, prospective, single arm study in which the lower
one-sided confidence interval exceeds the performance goal. Enrollment is expected to occur
within an 18-month time period at up to 40 centers. All patients will be followed for all
endpoints for 6 months while on DuraHeart™ LVAS support, or until cardiac transplantation or
death, whichever occurs first. For those patients who remain on support after 180 days,
survival and device reliability data will continue to be collected on a regular basis. If
patients are transplanted, survival at day 30 post cardiac transplantation will also be
assessed.


Inclusion Criteria:

The following are general criteria; more specific conditions are included in the study
protocol:

1. Approved for cardiac transplantation

2. Listed with UNOS on the Status 1 list

3. Patient for whom LVAS implantation is planned as a clinically indicated bridge to
cardiac transplantation

Exclusion Criteria:

The following are general criteria; more specific conditions are included in the study
protocol:

1. Contraindication to the administration of warfarin or anti-platelet agents

2. Primary coagulopathy or platelet disorder

3. Acute myocardial infarction within 48 hours prior to enrollment

4. Anticipated need for RVAD support or ECMO at the time of LVAS implantation

5. Prior cardiac transplantation, left ventricular reduction surgery, cardiomyoplasty,
passive restraint device (i.e., CorCapTM Cardiac Support Device) or surgically
implanted left ventricular assist device
We found this trial at
26
sites
Dallas, Texas 75230
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Los Angeles, California 90033
213) 740-2311
University of Southern California The University of Southern California is one of the world’s leading...
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Los Angeles, CA
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Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
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Miami, FL
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116th St and Broadway
New York, New York 10027
(212) 854-1754
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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New York, NY
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1 Tampa General Cir
Tampa, Florida 33606
(813) 844-7000
Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
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Tampa, FL
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Atlanta, Georgia 30342
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Birmingham, Alabama 35294
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Birmingham, AL
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80 Seymour St
Hartford, Connecticut 6102
(860) 545-5000
The Hartford Hospital Hartford Hospital is the major teaching hospital affiliated with the University of...
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Hershey, Pennsylvania 17033
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Houston, Texas 77030
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Houston, TX
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Houston, Texas 77225
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Indianapolis, Indiana
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Indianapolis, IN
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Madison, Wisconsin 53792
(608) 263-2400
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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2900 W Oklahoma Ave
Milwaukee, Wisconsin 53215
414-649-6000
Aurora St. Luke's Medical Center At Aurora St. Luke's Medical Center, you'll find remarkable treatment...
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Minneapolis, Minnesota 55407
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New Haven, Connecticut 6520
(203) 432-4771
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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New York, New York 10029
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Newark, New Jersey 07112
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1801 N Broad St
Philadelphia, Pennsylvania 19122
(215) 204-7000
Temple University Temple University is many things to many people. A place to pursue life's...
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Phoenix, Arizona 85054
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320 E North Ave
Pittsburgh, Pennsylvania 15212
(412) 359-3131
Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
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Rochester, Minnesota 55905
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Spokane, Washington 99204
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Toronto, Ontario
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Tucson, Arizona 85724
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