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NCT00483197 Clinical Trial

VentrAssistTM LVAD as a Bridge to Cardiac Transplantation - Pivotal Trial

Cardiomyopathies Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00483197
Other study ID # CLP 06005
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received June 4, 2007
Last updated September 4, 2009
Start date June 2007
Est. completion date June 2010

Study information
Verified date September 2009
Source Ventracor
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 140
Est. completion date June 2010
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• VentrAssistTM Left Ventricular Assist Device

Locations
Country Name City State
United States University of Maryland School of Medicine Baltimore Maryland
United States University of Alabama Birmingham Alabama
United States Montefiore Medical Center Bronx New York
United States Northwestern University Chicago Illinois
United States Rush University Medical Center Chicago Illinois
United States Cleveland Clinic Cleveland Ohio
United States Ohio State University Columbus Ohio
United States Duke Medical Center Durham North Carolina
United States Fairfax (Inova) Hospital Falls Church Virginia
United States University of Florida Gainesville Florida
United States Methodist Hospital Houston Texas
United States St. Vincent's Indianapolis Indiana
United States University of Wisconsin Hospital Madison Wisconsin
United States Jackson Memorial Miami Florida
United States St. Luke's Medical Center Milwaukee Wisconsin
United States University of Minnesota Medical Center Minneapolis Minnesota
United States Columbia University New York New York
United States Mount Sinai Hospital New York New York
United States Newark Beth Israel Medical Center Newark New Jersey
United States Hospital of the University of Pennsylvania Philadelphia Pennsylvania
United States Mayo Clinic Phoenix Arizona
United States Allegheny General Hospital Pittsburgh Pennsylvania
United States UPMC Presbyterian Pittsburgh Pennsylvania
United States Mayo Clinic Rochester Minnesota
United States Rochester Medical Center University Rochester New York
United States University of Utah Salt Lake City Utah
United States University of Washington Seattle Washington
United States Sacred Heart Medical Center Spokane Washington
United States Washington University School of Medicine St. Louis Missouri

Sponsors (2)
Lead Sponsor Collaborator
Ventracor International Center for Health Outcomes and Innovation Research

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Survival to cardiac transplantation or to 180 days post implantation and listed for cardiac transplantation in categories UNOS 1A or 1B.
Secondary Quality of life
Secondary Functional status
Secondary Neurocognitive function
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