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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. (see Contacts and Locations)
Verified June 2013 by Jarvik Heart, Inc.
Sponsor:
Information provided by (Responsible Party):
Jarvik Heart, Inc.
ClinicalTrials.gov Identifier:
NCT01627821
First received: June 22, 2012
Last updated: June 26, 2013
Last verified: June 2013
  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 Phase
Heart Failure
Device: Jarvik 2000 VAS
Device: HeartMate II
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]
    Serious adverse events

  • Quality of life [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Quality of life


Estimated Enrollment: 350
Study Start Date: February 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (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
Other Name: Jarvik 2000 VAS
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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01627821

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

Locations
United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Contact: Bartley Griffith, MD    410-328-3822    bgriffith@smail.umaryland.edu   
Sponsors and Collaborators
Jarvik Heart, Inc.
Investigators
Study Chair: Robert Jarvik, MD Jarvik Heart, Inc. SPONSOR
  More Information

No publications provided

Responsible Party: Jarvik Heart, Inc.
ClinicalTrials.gov Identifier: NCT01627821     History of Changes
Other Study ID Numbers: G100124
Study First Received: June 22, 2012
Last Updated: June 26, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Jarvik Heart, Inc.:
Heart Failure

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 25, 2014