VentrAssistTM LVAD as a Bridge to Cardiac Transplantation - Pivotal Trial

Phase 3

• Conditions: End-stage Heart Failure; Cardiomyopathies

• Registration Number: NCT00483197
• Lead Sponsor: Ventracor

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.

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-06-04
• Study First Submitted QC: 2007-06-04
• Study First Posted: 2007-06-06
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-04
• Last Update Posted: 2009-09-09
• Study Completion: 2010-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Quality of life
Functional status
Neurocognitive function

Trial Locations

Locations (28)

University of Alabama; 🇺🇸 Birmingham, Alabama, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States

Jackson Memorial; 🇺🇸 Miami, Florida, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

St. Vincent's; 🇺🇸 Indianapolis, Indiana, United States

University of Maryland School of Medicine; 🇺🇸 Baltimore, Maryland, United States

University of Minnesota Medical Center; 🇺🇸 Minneapolis, Minnesota, United States

Washington University School of Medicine; 🇺🇸 St. Louis, Missouri, United States

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