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Evaluation of the Jarvik 2000 Left Ventricular Assist System With Post-Auricular Connector--Destination Therapy Study

This study is currently recruiting participants.
Verified October 2017 by Jarvik Heart, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01627821
First Posted: June 26, 2012
Last Update Posted: October 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Jarvik Heart, Inc.
  Purpose
This investigation will be conducted as an interventional intention-to-treat clinical study in a population of end stage heart failure patients who meet specific inclusion and exclusion criteria. The multi-center study will be prospective, dual-armed, non-blinded (open-label) and randomized, comparing a treatment group receiving the Jarvik 2000 LVAS with Post-Auricular Connector to an active control group treated with the PMA approved Thoratec HeartMate® II LVAS for Destination Therapy.

Condition Intervention
Heart Failure Device: Jarvik 2000 VAS Device: HeartMate II

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Jarvik 2000 Left Ventricular Assist System With Post-Auricular Connector--Destination Therapy Study

Resource links provided by NLM:


Further study details as provided by Jarvik Heart, Inc.:

Primary Outcome Measures:
  • Non-inferiority to Control Group. [ Time Frame: 2 years ]

    Study Success for Primary Endpoint A will be established if the proportion of subjects in the Treatment Group meeting the Subject Success Criteria A, is determined to be non-inferior to that of the Control Group (at two years) according to the pre-specified statistical analysis.

    Subject composite success requires the subject to achieve the Effectiveness Endpoint:

    1. Two year actuarial survival
    2. Freedom from procedures to repair, or replace the implanted device
    3. Freedom from stroke resulting in a Modified Rankin Score of >3 at the two-year follow-up


Secondary Outcome Measures:
  • Serious adverse events [ Time Frame: 2 years ]
    Serious adverse events

  • Quality of life [ Time Frame: 2 years ]
    Quality of life


Estimated Enrollment: 350
Study Start Date: February 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Jarvik 2000 Treatment
Jarvik 2000 VAS, Post-Auricular Cable
Device: Jarvik 2000 VAS
Jarvik 2000 LVAD
Active Comparator: HeartMate II Control
HeartMate II VAS Control
Device: HeartMate II
HeartMate II LVAD
Other Name: HM II

Detailed Description:

Study Success for Primary Endpoint A will be established if the proportion of subjects in the Treatment Group meeting the Subject Success Criteria A, is determined to be non-inferior to that of the Control Group (at two years) according to the pre-specified statistical analysis.

Subject composite success requires the subject to achieve the Effectiveness Endpoint:

  1. Two year actuarial survival
  2. Freedom from procedures to repair, or replace the implanted device
  3. Freedom from stroke resulting in a Modified Rankin Score of >3 at the two-year follow-up

Study Success for Primary Endpoint B will be established if the proportion of subjects in the Treatment Group meeting the Subject Success Criteria B is determined to be superior to that of the Control Group (at three years) according to the pre-specified statistical analysis.

Subject composite success requires the subject to achieve the Effectiveness Endpoint:

  1. Three year survival
  2. Freedom from the serious adverse event of drive cable or pump pocket infection
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Cardiac transplantation ineligible.
  2. Late stage heart failure in NYHA Class IIIb or IV for at least 45 of past 60 days.
  3. Cardiac Index < 2.2 L / min / m2
  4. LVEF = 25% or less
  5. Patients on Optimal Medical Management (OMM) as defined in Section 9.2 OR dependent on intra-aortic balloon counter-pulsation for 7 days OR other temporary (indicated for 30 days use, or less) mechanical circulatory support for 7 days, OR supported with IV inotropes for 7 days and failing to respond.
  6. BSA > 1.2 m2 and < 2.5 m2.

Exclusion Criteria:

  1. History of cardiac transplantation or left ventricular reduction procedure.
  2. Clinical conditions, other than heart failure, which could limit survival to less than three years.
  3. Cause of heart failure due to, or associated with, uncorrected thyroid disease, obstructive / restrictive cardiomyopathy, pericardial disease, amyloidosis, dermatomyositis, or active myocarditis.
  4. Intolerance to anti-coagulation or anti-aggregation therapy required for post-operative therapy.
  5. Known sensitivity to products of bovine origin. The Jarvik 2000 incorporates a Hemashield vascular graft. Patients with a known sensitivity to products of bovine origin should not be implanted.
  6. Chronic immunosuppression.
  Contacts and Locations
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): NCT01627821


Contacts
Contact: Mary Blinder, MD 212-397-3911 ext 30 clinical@jarvikheart.com

Locations
United States, New York
Columbia/NY Presbyterian Recruiting
New York, New York, United States, 10032
Contact: Yoshifumi Naka, MD PhD    212-305-0828      
Sponsors and Collaborators
Jarvik Heart, Inc.
Investigators
Study Chair: Robert Jarvik, MD Jarvik Heart, Inc. SPONSOR
  More Information

Responsible Party: Jarvik Heart, Inc.
ClinicalTrials.gov Identifier: NCT01627821     History of Changes
Other Study ID Numbers: G100124
First Submitted: June 22, 2012
First Posted: June 26, 2012
Last Update Posted: October 16, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jarvik Heart, Inc.:
Heart Failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases