Evaluation of the Safety and Effectiveness of the DuraHeart™ LVAS
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of the Safety and Effectiveness of the DuraHeart™ Left Ventricular Assist System in Patients Awaiting Transplantation|
- Survival to cardiac transplantation or to 180 days post implantation and listed for cardiac transplantation in categories UNOS 1A or 1B. [ Time Frame: 180 days ] [ Designated as safety issue: No ]
- Survival to 180 days or Transplanted [ Time Frame: 180 days ] [ Designated as safety issue: No ]
- Incidence of adverse events [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
- Quality of life [ Time Frame: Baseline, 1 month, 6 months, and annually ] [ Designated as safety issue: No ]
- Functional status [ Time Frame: Baseline, 1 month, 3 months, 6 months, and annually ] [ Designated as safety issue: No ]
|Study Start Date:||July 2008|
|Estimated Study Completion Date:||January 2012|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Device: DuraHeart Left Ventricular Assist System (LVAS)
Show 26 Study Locations
|Principal Investigator:||Francis D. Pagani, M.D., Ph.D.||University of Michigan|
|Principal Investigator:||Yoshifumi Naka, M.D., Ph.D.||Columbia University|
|Principal Investigator:||David S Feldman, MD||Minneapolis Heart Institute|