Back to resultsEvaluation of the Jarvik 2000 Left Ventricular Assist System With Post-Auricular Connector--Destination Therapy Study
Primary Purpose
Heart Failure
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Jarvik 2000 VAS
HeartMate II
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure
Eligibility Criteria
Inclusion Criteria:
- Cardiac transplantation ineligible.
- Late stage heart failure in NYHA Class IIIb or IV for at least 45 of past 60 days.
- Cardiac Index < 2.2 L / min / m2
- LVEF = 25% or less
- 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.
- BSA > 1.2 m2 and < 2.5 m2.
Exclusion Criteria:
- History of cardiac transplantation or left ventricular reduction procedure.
- Clinical conditions, other than heart failure, which could limit survival to less than three years.
- Cause of heart failure due to, or associated with, uncorrected thyroid disease, obstructive / restrictive cardiomyopathy, pericardial disease, amyloidosis, dermatomyositis, or active myocarditis.
- Intolerance to anti-coagulation or anti-aggregation therapy required for post-operative therapy.
- 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.
- Chronic immunosuppression.
Sites / Locations
- Columbia/NY PresbyterianRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Jarvik 2000 Treatment
HeartMate II Control
Arm Description
Jarvik 2000 VAS, Post-Auricular Cable
HeartMate II VAS Control
Outcomes
Primary Outcome Measures
Non-inferiority to Control Group.
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:
Two year actuarial survival
Freedom from procedures to repair, or replace the implanted device
Freedom from stroke resulting in a Modified Rankin Score of >3 at the two-year follow-up
Secondary Outcome Measures
Serious adverse events
Serious adverse events
Quality of life measures: Questionnaire
Kansas City Cardiomyopathy Questionnaire. There are 23 items. Scores from 0-100 in which a higher score indicates better quality of life.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01627821
Brief Title
Evaluation of the Jarvik 2000 Left Ventricular Assist System With Post-Auricular Connector--Destination Therapy Study
Official Title
Evaluation of the Jarvik 2000 Left Ventricular Assist System With Post-Auricular Connector--Destination Therapy Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 2013 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jarvik Heart, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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:
Two year actuarial survival
Freedom from procedures to repair, or replace the implanted device
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:
Three year survival
Freedom from the serious adverse event of drive cable or pump pocket infection
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
350 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Jarvik 2000 Treatment
Arm Type
Active Comparator
Arm Description
Jarvik 2000 VAS, Post-Auricular Cable
Arm Title
HeartMate II Control
Arm Type
Active Comparator
Arm Description
HeartMate II VAS Control
Intervention Type
Device
Intervention Name(s)
Jarvik 2000 VAS
Intervention Description
Jarvik 2000 LVAD
Intervention Type
Device
Intervention Name(s)
HeartMate II
Other Intervention Name(s)
HM II
Intervention Description
HeartMate II LVAD
Primary Outcome Measure Information:
Title
Non-inferiority to Control Group.
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:
Two year actuarial survival
Freedom from procedures to repair, or replace the implanted device
Freedom from stroke resulting in a Modified Rankin Score of >3 at the two-year follow-up
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Serious adverse events
Description
Serious adverse events
Time Frame
2 years
Title
Quality of life measures: Questionnaire
Description
Kansas City Cardiomyopathy Questionnaire. There are 23 items. Scores from 0-100 in which a higher score indicates better quality of life.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Cardiac transplantation ineligible.
Late stage heart failure in NYHA Class IIIb or IV for at least 45 of past 60 days.
Cardiac Index < 2.2 L / min / m2
LVEF = 25% or less
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.
BSA > 1.2 m2 and < 2.5 m2.
Exclusion Criteria:
History of cardiac transplantation or left ventricular reduction procedure.
Clinical conditions, other than heart failure, which could limit survival to less than three years.
Cause of heart failure due to, or associated with, uncorrected thyroid disease, obstructive / restrictive cardiomyopathy, pericardial disease, amyloidosis, dermatomyositis, or active myocarditis.
Intolerance to anti-coagulation or anti-aggregation therapy required for post-operative therapy.
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.
Chronic immunosuppression.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mary Blinder, MD
Phone
212-397-3911
Ext
30
Email
clinical@jarvikheart.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Jarvik, MD
Organizational Affiliation
Jarvik Heart, Inc. SPONSOR
Official's Role
Study Chair
Facility Information:
Facility Name
Columbia/NY Presbyterian
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoshifumi Naka, MD PhD
Phone
212-305-0828
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of the Jarvik 2000 Left Ventricular Assist System With Post-Auricular Connector--Destination Therapy Study
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