VentrAssistTM LVAD as a Bridge to Cardiac Transplantation - Pivotal Trial

Ventracor

Status and phase

Unknown

Phase 3

Conditions

End-stage Heart Failure

Cardiomyopathies

Treatments

Device: VentrAssistTM Left Ventricular Assist Device

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00483197

CLP 06005

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and effectiveness of VentrAssistTM LVAD in individuals who are awaiting heart transplants.

Full 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.

Enrollment

140 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.