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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.
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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Jarvik 2000 Treatment | Active Comparator | Jarvik 2000 VAS, Post-Auricular Cable |
|
| HeartMate II Control | Active Comparator | HeartMate II VAS Control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jarvik 2000 VAS | Device | Jarvik 2000 LVAD |
| |
| HeartMate II |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Serious adverse events | Serious adverse events | 2 years |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robert Jarvik, MD | Contact | 212-397-3911 | clinical@jarvikheart.com |
| Name | Affiliation | Role |
|---|---|---|
| Robert Jarvik, MD | Jarvik Heart, Inc. SPONSOR | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia/NY Presbyterian | Recruiting | New York | New York | 10032 | United States |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Device |
HeartMate II LVAD |
|
|
| 2 years |