Evaluation of the VentrAssistTM Left Ventricular Assist Device as a Bridge to Cardiac Transplantation - Pivotal Trial
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Enrollment
- 140
- Locations
- 55
- Primary Endpoint
- Survival to cardiac transplantation or to 180 days post implantation and listed for cardiac transplantation in categories UNOS 1A or 1B.
Study Overview
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of VentrAssistTM LVAD in individuals who are awaiting heart transplants.
Detailed Description
LVADs are efficacious in improving survival and functional status when used as a bridge to transplantation. The purpose of this study is to evaluate the safety and effectiveness of the VentrAssist LVAD in providing circulatory support in individuals who are awaiting heart transplants.
The VentrAssist LVAD is a centrifugal flow pump. Its small size and mechanical simplicity offers benefits not available with currently approved LVADs, including facilitating a more limited implantation procedure, which could reduce surgical morbidity and mortality.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- 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; 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.
Outcomes
Primary Outcomes
Survival to cardiac transplantation or to 180 days post implantation and listed for cardiac transplantation in categories UNOS 1A or 1B.
Secondary Outcomes
- Quality of life
- Functional status
- Neurocognitive function