End-Stage Heart FailurePhase 2NCT00490347
VentrAssistTM LVAD as a Bridge to Cardiac Transplantation - Feasibility Trial
A Phase 2 study testing VentrAssist Left Ventricular Assist Device in people with End-Stage Heart Failure and Cardiomyopathies, run by Ventracor at 5 sites in United States.
Trial summary
The purpose of this trial is to determine the safety and feasibility of the VentrAssist LVAD in providing circulatory support for patients who require an LVAD as a bridge to cardiac transplantation. 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?
- VentrAssist Left Ventricular Assist Device
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 5 sitesUnited States
- Study dates
- Jul 2005to Oct 2007
- Phase
- Phase 2
- 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
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Maryland Medical Center - Baltimore
Baltimore, Maryland, 21201
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
University of Minnesota Medical Center - Fairview
Minneapolis, Minnesota, 55455
New York Presbyterian Medical Center - Columbia
New York, New York, 10032
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Evaluation of the VentrAssistTM Left Ventricular Assist Device as a Bridge to Cardiac Transplantation - Feasibility Trial
The purpose of this trial is to determine the safety and feasibility of the VentrAssist LVAD in providing circulatory support for patients who require an LVAD as a bridge to cardiac transplantation.
- Conditions
- End-Stage Heart Failure, Cardiomyopathies
- Being tested
- VentrAssist 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.
VentrAssist Left Ventricular Assist DeviceDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
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 posted22 Jun 2007 (estimated)
- Study startJul 2005
- Study completionOct 2007
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT00490347
- Sponsor's protocol ID
- CLP070012
- Status last verified
- Jan 2008
- First submitted
- 20 Jun 2007
- Last updated
- 17 Jan 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2008. 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 - Feasibility Trial
- ClinicalTrials.gov ID
- NCT00490347
- Acronym / sponsor ID
- CLP070012
- Conditions
- End-Stage Heart Failure, Cardiomyopathies
- Keywords
- VentrAssistTM, LVAD, End-stage heart failure, Cardiomyopathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- VentracorIndustry (pharma, biotech, devices)
- Collaborators
- International Center for Health Outcomes and Innovation Research
- Study start
- Jul 2005
- Study completion
- Oct 2007 (actual)
- First posted
- 22 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 trial is to determine the safety and feasibility of the VentrAssist LVAD in providing circulatory support for patients who require an LVAD as a bridge to cardiac transplantation.
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 |
|---|---|---|
| VentrAssist Left Ventricular Assist Device | Device | – |
Primary outcome
Survival
3 secondary outcomes
Quality of life
Functional status
Neurocognitive function
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2008.
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VentrAssist Left Ventricular Assist Device in people with End-Stage Heart Failure and Cardiomyopathies, run by Ventracor at 5 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: finished, as of the sponsor's last update on 17 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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. 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 17 Jan 2008.