VentrAssistTM LVAD as a Bridge to Cardiac Transplantation - Pivotal Trial

NCT ID: NCT00483197

Last Updated: 2009-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2010-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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End-stage Heart Failure Cardiomyopathies

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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VentrAssistTM Left Ventricular Assist Device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Approved and listed for cardiac transplantation.
* Patient for whom LVAD implantation is planned as a clinically indicated bridge to cardiac transplantation.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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International Center for Health Outcomes and Innovation Research

OTHER

Sponsor Role collaborator

Ventracor

INDUSTRY

Sponsor Role lead

Responsible Party

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Washington Hospital/Barnes Jewish Hospital

Locations

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University of Alabama

Birmingham, Alabama, United States

Site Status

Mayo Clinic

Phoenix, Arizona, United States

Site Status

University of Florida

Gainesville, Florida, United States

Site Status

Jackson Memorial

Miami, Florida, United States

Site Status

Northwestern University

Chicago, Illinois, United States

Site Status

Rush University Medical Center

Chicago, Illinois, United States

Site Status

St. Vincent's

Indianapolis, Indiana, United States

Site Status

University of Maryland School of Medicine

Baltimore, Maryland, United States

Site Status

University of Minnesota Medical Center

Minneapolis, Minnesota, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Newark Beth Israel Medical Center

Newark, New Jersey, United States

Site Status

Mount Sinai Hospital

New York, New York, United States

Site Status

Columbia University

New York, New York, United States

Site Status

Rochester Medical Center University

Rochester, New York, United States

Site Status

Montefiore Medical Center

The Bronx, New York, United States

Site Status

Duke Medical Center

Durham, North Carolina, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Ohio State University

Columbus, Ohio, United States

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Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

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UPMC Presbyterian

Pittsburgh, Pennsylvania, United States

Site Status

Methodist Hospital

Houston, Texas, United States

Site Status

University of Utah

Salt Lake City, Utah, United States

Site Status

Fairfax (Inova) Hospital

Falls Church, Virginia, United States

Site Status

University of Washington

Seattle, Washington, United States

Site Status

Sacred Heart Medical Center

Spokane, Washington, United States

Site Status

University of Wisconsin Hospital

Madison, Wisconsin, United States

Site Status

St. Luke's Medical Center

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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CLP 06005

Identifier Type: -

Identifier Source: org_study_id

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