Cardiomyopathies, End-Stage Heart Failure
Conditions
Keywords
VentrAssistTM, LVAD, End-stage heart failure, Cardiomyopathy
Brief summary
The purpose of this trial is to determine the safety and feasibility of the VentrAssist LVAD in providing circulatory support for patients who require an LVAD as a bridge to cardiac transplantation.
Interventions
DEVICEVentrAssist Left Ventricular Assist Device
Sponsors
International Center for Health Outcomes and Innovation Research
Ventracor
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(The following are general criteria; more specific criteria are included in the study protocol): * Approved and listed for cardiac transplantation. * Patient for whom LVAD implantation is planned as a clinically indicated bridge to cardiac transplantation.
Exclusion criteria
(The following are general criteria; more specific criteria are included in the study protocol): * Presence of heart conditions that would contraindicate LVAD implantation by adversely affecting patient survival or LVAD function. * Primary coagulopathy or platelet disorder; contraindication to anticoagulant or anti-platelet agents. * Presence of any mechanical circulatory support other than intra-aortic balloon pump. * Therapy with an investigational intervention at the time of screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life | — |
| Functional status | — |
| Neurocognitive function | — |
Countries
United States
Outcome results
None listed