VentrAssistTM LVAD for the Treatment of Advanced Heart Failure - Destination Therapy

NCT ID: NCT00490321

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

225 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2012-06-30

Brief Summary

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The purpose of this study is to evaluate the safety and effectiveness of LVADs in providing long-term circulatory support for patients who have chronic stage D heart failure and are ineligible for a heart transplant.

This is a multi-center, prospective, randomized, controlled clinical trial, which is comprised of two independent modules.

Detailed Description

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Currently, patients with Stage D heart failure who are not transplant candidates are treated with a spectrum of therapies, including specialized medical management as well as mechanical support with an LVAD approved by FDA for destination therapy. However, there is substantial variation in the therapeutic approaches employed to treat these patients, with relatively low numbers of patients receiving DT LVAD therapy to date. Therefore, the VentrAssist DT trial is designed to provide maximal flexibility to the investigators/clinicians to incorporate their clinical judgment in managing these complex patients.

Conditions

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End-stage Heart Failure Cardiomyopathies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

* Eligible for either the VentrAssist or an FDA-approved DT LVAD
* LVEF \<=25%
* Stage D heart failure
* Ineligible for cardiac transplantation
* Treated with standard heart failure therapy

Exclusion Criteria

* Contraindication to LVAD implantation
* Contraindication to anticoagulant or anti-platelet agents.
* Pre-existing mechanical circulatory support other than intra-aortic balloon pump
* Therapy with an investigational intervention at the time of screening
* A condition, other than heart failure, which would limit survival to less than 2 years
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

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

St. Vincent's

Indianapolis, Indiana, United States

Site Status

University of Maryland School of Medicine

Baltimore, Maryland, United States

Site Status

University of Minnesota

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

Ohio State University

Columbus, Ohio, United States

Site Status

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Site Status

University of Pittsburgh Medical Center

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 12082

Identifier Type: -

Identifier Source: org_study_id

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