VentrAssistTM LVAD as a Bridge to Cardiac Transplantation - Feasibility Trial

Ventracor

Status and phase: Completed; Phase 2

Conditions: End-Stage Heart Failure; Cardiomyopathies

Treatments: Device: VentrAssist Left Ventricular Assist Device

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00490347

CLP070012

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)