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Evaluation of the Safety and Effectiveness of the DuraHeart™ LVAS

This study has been terminated.
(Insufficient enrollment)
Sponsor:
Information provided by (Responsible Party):
Terumo Heart Inc.
ClinicalTrials.gov Identifier:
NCT00710567
First received: July 2, 2008
Last updated: December 23, 2011
Last verified: December 2011
History of Changes
  Purpose

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.


Condition Intervention
Heart Failure
 Device: DuraHeart Left Ventricular Assist System (LVAS)

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Terumo Heart Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 66
Study Start Date: July 2008
Estimated Study Completion Date: January 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: DuraHeart Left Ventricular Assist System (LVAS)
    The DuraHeart LVAS is implanated in using open heart surgery
    Other Name: LVAD
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00710567

  Show 26 Study Locations
Sponsors and Collaborators
Terumo Heart Inc.
Investigators
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
  More Information

No publications provided

Responsible Party: Terumo Heart Inc.
ClinicalTrials.gov Identifier: NCT00710567     History of Changes
Other Study ID Numbers: DH003
Study First Received: July 2, 2008
Last Updated: December 23, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Terumo Heart Inc.:
Heart Failure
LVAS
LVAD
Rotary Pump

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013