Overview

This trial is active, not recruiting.

Conditions end-stage heart failure, cardiomyopathies
Treatment ventrassisttm left ventricular assist device
Phase phase 3
Sponsor Ventracor
Collaborator International Center for Health Outcomes and Innovation Research
Start date June 2007
End date June 2010
Trial size 140 participants
Trial identifier NCT00483197, CLP 06005

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

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

Secondary Outcomes

Measure
Quality of life
time frame:
Functional status
time frame:
Neurocognitive function
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Evaluation of the VentrAssistTM Left Ventricular Assist Device as a Bridge to Cardiac Transplantation - Pivotal Trial
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2009.
Information provided to ClinicalTrials.gov by Ventracor.