Evaluation of the Safety and Effectiveness of the DuraHeart™ LVAS

December 11, 2019 updated by: Terumo Heart Inc.

Evaluation of the Safety and Effectiveness of the DuraHeart™ Left Ventricular Assist System in Patients Awaiting Transplantation

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1Z5
        • Toronto General Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic - Phoenix
      • Tucson, Arizona, United States, 85724
        • University of Arizona Medical Center
    • California
      • Los Angeles, California, United States, 90033
        • University of Southern California
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Hartford Hospital
      • New Haven, Connecticut, United States, 06520
        • Yale University
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami
      • Tampa, Florida, United States, 33606
        • Tampa General Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • St. Joseph's Hospital of Atlanta
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • St. Vincent Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Minneapoils Heart Institute Foundation
      • Rochester, Minnesota, United States, 55902
        • Mayo Clinic
    • New Jersey
      • Newark, New Jersey, United States, 07112
        • Newark Beth Israel
    • New York
      • New York, New York, United States, 10032
        • Columbia University
      • New York, New York, United States, 10029
        • Mt. Sinai School of Medicine
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State University
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital
    • Texas
      • Dallas, Texas, United States, 75230
        • Medical City
      • Houston, Texas, United States, 77030
        • Methodist Hospital
      • Houston, Texas, United States, 77030
        • Texas Heart Institute
    • Washington
      • Spokane, Washington, United States, 99204
        • Sacred Heart Medical Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Aurora St. Luke's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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 implanted in using open heart surgery
Other Names:
  • LVAD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2008

Primary Completion (Actual)

January 31, 2012

Study Completion (Actual)

November 12, 2018

Study Registration Dates

First Submitted

July 2, 2008

First Submitted That Met QC Criteria

July 2, 2008

First Posted (Estimate)

July 4, 2008

Study Record Updates

Last Update Posted (Actual)

December 13, 2019

Last Update Submitted That Met QC Criteria

December 11, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DH003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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