Evaluation of the VentrAssistTM Left Ventricular Assist Device for the Treatment of Advanced Heart Failure - Destination Therapy
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Enrollment
- 225
- Locations
- 50
- Primary Endpoint
- Module A: Survival without a disabling stroke.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
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 Outcomes
- •Safety •Functional Status and Hospitalizations •Quality of Life and Neurocognitive Assessment