VentrAssistTM LVAD as a Bridge to Cardiac Transplantation - Pivotal Trial

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00483197

Enrollment

140

Registered

2007-06-06

Start date

2007-06-30

Completion date

2010-06-30

Last updated

2009-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiomyopathies, End-stage Heart Failure

Keywords

VentrAssistTM, LVAD, End-stage heart failure, Cardiomyopathy

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.

Interventions

DEVICEVentrAssistTM Left Ventricular Assist Device

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Survival to cardiac transplantation or to 180 days post implantation and listed for cardiac transplantation in categories UNOS 1A or 1B.	—

Secondary

Measure	Time frame
Quality of life	—
Functional status	—
Neurocognitive function	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026