Evaluation of the Safety and Effectiveness of the DuraHeart™ LVAS

Stopped early · Not applicable

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID

NCT00710567

Run by

Terumo Heart Inc.

People needed

66

Starts

2008-07-01

Expected to finish

2018-11-12

Last updated by the study team

2019-12-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• Mayo Clinic - Phoenix — Phoenix, Arizona, United States
• University of Arizona Medical Center — Tucson, Arizona, United States
• University of Southern California — Los Angeles, California, United States
• Hartford Hospital — Hartford, Connecticut, United States
• Yale University — New Haven, Connecticut, United States
• University of Miami — Miami, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• St. Joseph's Hospital of Atlanta — Atlanta, Georgia, United States
• St. Vincent Hospital — Indianapolis, Indiana, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Minneapoils Heart Institute Foundation — Minneapolis, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Newark Beth Israel — Newark, New Jersey, United States
• Mt. Sinai School of Medicine — New York, New York, United States
• Columbia University — New York, New York, United States
• Penn State University — Hershey, Pennsylvania, United States
• Temple University — Philadelphia, Pennsylvania, United States
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
• Medical City — Dallas, Texas, United States
• Methodist Hospital — Houston, Texas, United States
• Texas Heart Institute — Houston, Texas, United States
• Sacred Heart Medical Center — Spokane, Washington, United States
• University of Wisconsin — Madison, Wisconsin, United States
• Aurora St. Luke's Medical Center — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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