Cardiomyopathies, End-stage Heart Failure
Conditions
Keywords
VentrAssistTM, LVAD, End-stage heart failure, Cardiomyopathy
Brief summary
The purpose of this study is to evaluate the safety and effectiveness of LVADs in providing long-term circulatory support for patients who have chronic stage D heart failure and are ineligible for a heart transplant. This is a multi-center, prospective, randomized, controlled clinical trial, which is comprised of two independent modules.
Detailed description
Currently, patients with Stage D heart failure who are not transplant candidates are treated with a spectrum of therapies, including specialized medical management as well as mechanical support with an LVAD approved by FDA for destination therapy. However, there is substantial variation in the therapeutic approaches employed to treat these patients, with relatively low numbers of patients receiving DT LVAD therapy to date. Therefore, the VentrAssist DT trial is designed to provide maximal flexibility to the investigators/clinicians to incorporate their clinical judgment in managing these complex patients.
Interventions
Sponsors
International Center for Health Outcomes and Innovation Research
Ventracor
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
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; detailed criteria are included in the study protocol): * Eligible for either the VentrAssist or an FDA-approved DT LVAD * LVEF \<=25% * Stage D heart failure * Ineligible for cardiac transplantation * Treated with standard heart failure therapy
Exclusion criteria
(The following are general criteria; detailed criteria are included in the study protocol): * Contraindication to LVAD implantation * Contraindication to anticoagulant or anti-platelet agents. * Pre-existing mechanical circulatory support other than intra-aortic balloon pump * Therapy with an investigational intervention at the time of screening * A condition, other than heart failure, which would limit survival to less than 2 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Module A: Survival without a disabling stroke. | — |
| Module B: A composite endpoint of disabling stroke-free survival without device replacement or repair due to failure of the device to provide adequate circulatory support. | — |
Secondary
| Measure | Time frame |
|---|---|
| •Safety •Functional Status and Hospitalizations •Quality of Life and Neurocognitive Assessment | — |
Countries
United States
Outcome results
None listed