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Evaluation of the Safety and Effectiveness of the DuraHeart™ LVAS

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ClinicalTrials.gov Identifier: NCT00710567
Recruitment Status : Active, not recruiting
First Posted : July 4, 2008
Last Update Posted : March 30, 2018
Sponsor:
Information provided by (Responsible Party):
Terumo Heart Inc.

Brief Summary:

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 or disease Intervention/treatment Phase
Heart Failure Device: DuraHeart Left Ventricular Assist System (LVAS) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Safety and Effectiveness of the DuraHeart™ Left Ventricular Assist System in Patients Awaiting Transplantation
Study Start Date : July 2008
Actual Primary Completion Date : January 2012
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arm Intervention/treatment
Historical Data
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
Device: DuraHeart Left Ventricular Assist System (LVAS)
The DuraHeart LVAS is implanated in using open heart surgery
Other Name: LVAD



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Survival to 180 days or Transplanted [ Time Frame: 180 days ]
  2. Incidence of adverse events [ Time Frame: 180 days ]
  3. Quality of life [ Time Frame: Baseline, 1 month, 6 months, and annually ]
  4. Functional status [ Time Frame: Baseline, 1 month, 3 months, 6 months, and annually ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Terumo Heart Inc.
ClinicalTrials.gov Identifier: NCT00710567     History of Changes
Other Study ID Numbers: DH003
First Posted: July 4, 2008    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases