NCT00710567|Terminated
Study Stopped
Insufficient enrollment
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Insufficient enrollment
Sponsor study identifier
interventional
66
2 countries
26
Study Start
July 2008
Actual (reported)Primary Completion
January 31, 2012
Actual (reported)Study Completion
November 12, 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 12, 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2008
Actual (reported)July 2, 2008
Actual (reported)July 4, 2008
Actual (reported)January 31, 2012
Actual (reported)November 12, 2018
Actual (reported)Survival to cardiac transplantation or to 180 days post implantation and listed for cardiac transplantation in categories UNOS 1A or 1B.
180 days
DuraHeart Patients will be implanted with a DuraHeart Left Ventricular Assist System (LVAS) as a "bridge to transplant" until a suitable heart can be found as a replacement. Parameters collected will be compared to a performance goal based on historical data for congestive heart failure patients
The DuraHeart LVAS is implanted in using open heart surgery
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Alabama
Birmingham, Alabama, 35294, United States
Mayo Clinic - Phoenix
Phoenix, Arizona, 85054, United States
University of Arizona Medical Center
Tucson, Arizona, 85724, United States
University of Southern California
Los Angeles, California, 90033, United States
Hartford Hospital
Hartford, Connecticut, 06106, United States
Yale University
New Haven, Connecticut, 06520, United States
University of Miami
Miami, Florida, 33136, United States
Francis D. Pagani, M.D., Ph.D.
University of Michigan
Yoshifumi Naka, M.D., Ph.D.
Columbia University
David S Feldman, MD
Minneapolis Heart Institute
66 participants (actual enrollment reported by the registry).
First Submitted
July 2, 2008
First Posted
July 4, 2008
Study Start
July 2008
Actual (reported)Primary Completion
Coping Skills and Heart Failure: Outcomes and Mechanisms
Contact the study team to confirm eligibility.
Tampa General Hospital
Tampa, Florida, 33606, United States
St. Joseph's Hospital of Atlanta
Atlanta, Georgia, 30342, United States
St. Vincent Hospital
Indianapolis, Indiana, 46260, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Minneapoils Heart Institute Foundation
Minneapolis, Minnesota, 55407, United States
Mayo Clinic
Rochester, Minnesota, 55902, United States
Newark Beth Israel
Newark, New Jersey, 07112, United States
Mt. Sinai School of Medicine
New York, New York, 10029, United States
Columbia University
New York, New York, 10032, United States
Penn State University
Hershey, Pennsylvania, 17033, United States
Temple University
Philadelphia, Pennsylvania, 19140, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
Medical City
Dallas, Texas, 75230, United States
Methodist Hospital
Houston, Texas, 77030, United States
Texas Heart Institute
Houston, Texas, 77030, United States
Sacred Heart Medical Center
Spokane, Washington, 99204, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Toronto General Hospital
Toronto, Ontario, M5G 1Z5, Canada
January 31, 2012
Actual (reported)Study Completion
November 12, 2018
Actual (reported)Last Updated
December 13, 2019
Record last verified: 2019-03
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Source: ClinicalTrials.gov.
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