End-stage Heart FailurePhase 3NCT00483197
VentrAssistTM LVAD as a Bridge to Cardiac Transplantation - Pivotal Trial
A Phase 3 study testing VentrAssistTM Left Ventricular Assist Device in people with End-stage Heart Failure and Cardiomyopathies, run by Ventracor at 29 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of VentrAssistTM LVAD in individuals who are awaiting heart transplants. 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
- 140 participants
- Where
- 29 sitesUnited States
- Study dates
- Jun 2007to Jun 2010
- 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; 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.
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
University of Maryland School of Medicine
Baltimore, Maryland, 21201
University of Alabama
Birmingham, Alabama, 35294
Northwestern University
Chicago, Illinois, 60611
Rush University Medical Center
Chicago, Illinois, 60612
Cleveland Clinic
Cleveland, Ohio, 44195
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, 33136
St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
University of Minnesota Medical Center
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
UPMC Presbyterian
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
About this study
Official title: Evaluation of the VentrAssistTM Left Ventricular Assist Device as a Bridge to Cardiac Transplantation - Pivotal Trial
The purpose of this study is to evaluate the safety and effectiveness of VentrAssistTM LVAD in individuals who are awaiting heart transplants.
Read the 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.
- Conditions
- End-stage Heart Failure, Cardiomyopathies
- 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.
Survival to cardiac transplantation or to 180 days post implantation and listed for cardiac transplantation in categories UNOS 1A or 1B.
Secondary outcomes (3)
Quality of life
Functional status
Neurocognitive function
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2007 (estimated)
- Study startJun 2007
- Study completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-stage Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ventracor
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- International Center for Health Outcomes and Innovation Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00483197
- Sponsor's protocol ID
- CLP 06005
- Status last verified
- Sep 2009
- First submitted
- 4 Jun 2007
- Last updated
- 9 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the VentrAssistTM Left Ventricular Assist Device as a Bridge to Cardiac Transplantation - Pivotal Trial
- ClinicalTrials.gov ID
- NCT00483197
- Acronym / sponsor ID
- CLP 06005
- Conditions
- End-stage Heart Failure, Cardiomyopathies
- Keywords
- VentrAssistTM, LVAD, End-stage heart failure, Cardiomyopathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- VentracorIndustry (pharma, biotech, devices)
- Collaborators
- International Center for Health Outcomes and Innovation Research
- Study start
- Jun 2007
- Study completion
- Jun 2010 (estimated)
- First posted
- 6 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VentrAssistTM Left Ventricular Assist Device | Device | – |
Primary outcome
Survival to cardiac transplantation or to 180 days post implantation and listed for cardiac transplantation in categories UNOS 1A or 1B.
3 secondary outcomes
Quality of life
Functional status
Neurocognitive function
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
29 sites in 1 country: see every site and its status.
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 29 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 29 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?
Survival to cardiac transplantation or to 180 days post implantation and listed for cardiac transplantation in categories UNOS 1A or 1B.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.