VentrAssistTM LVAD as a Bridge to Cardiac Transplantation - Feasibility Trial

Evaluation of the VentrAssistTM Left Ventricular Assist Device as a Bridge to Cardiac Transplantation - Feasibility Trial

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.

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.