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End-stage Heart FailurePhase 3NCT00490321

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

A Phase 3 study testing VentrAssistTM Left Ventricular Assist Device in people with End-stage Heart Failure and Cardiomyopathies, run by Ventracor at 27 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
End-stage Heart Failure, Cardiomyopathies
What is being tested?
VentrAssistTM Left Ventricular Assist Device
Type of treatment
Medical device
How many people
225 participants
Where
27 sitesUnited States
Study dates
Jun 2007to Jun 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Inclusion Criteria (The following are general criteria; detailed criteria are included in the study protocol):

  • 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 (The following are general criteria; detailed criteria are included in the study protocol):

  • 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

Trial locations and contacts

27 sites in 1 country.

27 sites in 1 country

United States27 sites

  • University of Maryland School of Medicine

    Baltimore, Maryland, 21201

  • University of Alabama

    Birmingham, Alabama, 35294

  • Northwestern University

    Chicago, Illinois, 60611

  • Ohio State University

    Columbus, Ohio, 43210

  • Duke Medical Center

    Durham, North Carolina, 27710

  • Fairfax (Inova) Hospital

    Falls Church, Virginia, 22042

  • University of Florida

    Gainesville, Florida, 32610

  • Methodist Hospital

    Houston, Texas, 77030

  • St. Vincent's

    Indianapolis, Indiana, 46260

  • University of Wisconsin Hospital

    Madison, Wisconsin, 53792

  • Jackson Memorial

    Miami, Florida

  • St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Mount Sinai Hospital

    New York, New York, 10029

  • Columbia University

    New York, New York, 10032

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Mayo Clinic

    Phoenix, Arizona, 85054

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • Mayo Clinic

    Rochester, Minnesota, 55904

  • Rochester Medical Center University

    Rochester, New York, 14642

  • University of Utah

    Salt Lake City, Utah, 84132

  • University of Washington

    Seattle, Washington, 98185

  • Sacred Heart Medical Center

    Spokane, Washington, 99204

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Montefiore Medical Center

    The Bronx, New York, 10467

Other trials in United States

About this study

Official title: Evaluation of the VentrAssistTM Left Ventricular Assist Device for the Treatment of Advanced Heart Failure - Destination Therapy

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.

Read the detailed description

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.

Being tested
VentrAssistTM Left Ventricular Assist Device
Keywords
VentrAssistTM, LVAD, End-stage heart failure, Cardiomyopathy
Medical subject headings
Cardiomyopathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VentrAssistTM Left Ventricular Assist DeviceDevice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Module A: Survival without a disabling stroke.

  2. Module B: A composite endpoint of disabling stroke-free survival without device replacement or repair due to failure of the device to provide adequate circulatory support.

Secondary outcomes (1)

  1. •Safety •Functional Status and Hospitalizations •Quality of Life and Neurocognitive Assessment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2007 (estimated)
  2. Study startJun 2007
  3. Study completionJun 2012 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
225 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00490321
Sponsor's protocol ID
CLP 12082
Status last verified
Sep 2009
First submitted
20 Jun 2007
Last updated
9 Sep 2009
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing VentrAssistTM Left Ventricular Assist Device in people with End-stage Heart Failure and Cardiomyopathies, run by Ventracor at 27 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Module A: Survival without a disabling stroke.. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00490321.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2009.

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