Heart FailureNCT00710567
Evaluation of the Safety and Effectiveness of the DuraHeart™ LVAS
A study testing DuraHeart Left Ventricular Assist System (LVAS) in people with Heart Failure, run by Terumo Heart Inc. at 26 sites in 2 countries.
Trial summary
Specific Aims The aims of this trial are to evaluate the safety and effectiveness of the DuraHeart™ LVAS in patients with advanced heart failure who require LVAS support 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
- Heart Failure
- What is being tested?
- DuraHeart Left Ventricular Assist System (LVAS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 26 sitesin 2 countries
- Study dates
- Jul 2008to 12 Nov 2018
- Phase
- Interventional
- 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
Who may be able to join
- The following are general criteria; more specific conditions are included in the study protocol:
- Approved for cardiac transplantation
- Listed with UNOS on the Status 1 list
- Patient for whom LVAS implantation is planned as a clinically indicated bridge to cardiac transplantation
Who cannot join
- The following are general criteria; more specific conditions are included in the study protocol:
- Contraindication to the administration of warfarin or anti-platelet agents
- Primary coagulopathy or platelet disorder
- Acute myocardial infarction within 48 hours prior to enrollment
- Anticipated need for RVAD support or ECMO at the time of LVAS implantation
- Prior cardiac transplantation, left ventricular reduction surgery, cardiomyoplasty, passive restraint device (i.e., CorCapTM Cardiac Support Device) or surgically implanted left ventricular assist device
Trial locations and contacts
26 sites in 2 countries.
26 sites in 2 countries
United States25 sites
University of Michigan
Ann Arbor, Michigan, 48109
St. Joseph's Hospital of Atlanta
Atlanta, Georgia, 30342
University of Alabama
Birmingham, Alabama, 35294
Medical City
Dallas, Texas, 75230
Hartford Hospital
Hartford, Connecticut, 06106
Penn State University
Hershey, Pennsylvania, 17033
Methodist Hospital
Houston, Texas, 77030
Texas Heart Institute
Houston, Texas, 77030
St. Vincent Hospital
Indianapolis, Indiana, 46260
University of Southern California
Los Angeles, California, 90033
University of Wisconsin
Madison, Wisconsin, 53792
University of Miami
Miami, Florida, 33136
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
Minneapoils Heart Institute Foundation
Minneapolis, Minnesota, 55407
Yale University
New Haven, Connecticut, 06520
Mt. Sinai School of Medicine
New York, New York, 10029
Columbia University
New York, New York, 10032
Newark Beth Israel
Newark, New Jersey, 07112
Temple University
Philadelphia, Pennsylvania, 19140
Mayo Clinic - Phoenix
Phoenix, Arizona, 85054
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Mayo Clinic
Rochester, Minnesota, 55902
Sacred Heart Medical Center
Spokane, Washington, 99204
Tampa General Hospital
Tampa, Florida, 33606
University of Arizona Medical Center
Tucson, Arizona, 85724
About this study
Official title: Evaluation of the Safety and Effectiveness of the DuraHeart™ Left Ventricular Assist System in Patients Awaiting Transplantation
Specific Aims The aims of this trial are to evaluate the safety and effectiveness of the DuraHeart™ LVAS in patients with advanced heart failure who require LVAS support as a bridge to cardiac transplantation.
Study Population The patient population for this trial consists of patients with end stage heart failure awaiting cardiac transplantation. Patients must be listed for transplant with UNOS with status 1A or 1B. All patients who meet the eligibility criteria may be included in the study regardless of gender, race or ethnicity.
Study Design This is a multi-center, prospective, single arm study in which the lower one-sided confidence interval exceeds the performance goal. Enrollment is expected to occur within an 18-month time period at up to 40 centers. All patients will be followed for all endpoints for 6 months while on DuraHeart™ LVAS support, or until cardiac transplantation or death, whichever occurs first. For those patients who remain on support after 180 days, survival and device reliability data will continue to be collected on a regular basis. If patients are transplanted, survival at day 30 post cardiac transplantation will also be assessed.
- Conditions
- Heart Failure
- Being tested
- DuraHeart Left Ventricular Assist System (LVAS)
- Keywords
- Heart Failure, LVAS, LVAD, Rotary Pump
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuraHeart Left Ventricular Assist System (LVAS)Device
Also called LVAD
The DuraHeart LVAS is implanted in using open heart surgery
| Study group | Role | What they receive |
|---|---|---|
| Historical Data | Other | DuraHeart Patients will be implanted with a DuraHeart Left Ventricular Assist System (LVAS) as a "bridge to transplant" until a suitable heart can be found as a replacement. Parameters collected will be compared to a performance goal based on historical data for congestive heart failure patients Receives: Device: DuraHeart Left Ventricular Assist System (LVAS) |
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.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2008 (estimated)
- Study startJul 2008
- Primary completion31 Jan 2012
- Study completion12 Nov 2018
Why it stopped: Insufficient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Terumo Heart Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Francis D. Pagani, M.D., Ph.D., Principal investigator, University of MichiganYoshifumi Naka, M.D., Ph.D., Principal investigator, Columbia UniversityDavid S Feldman, MD, Principal investigator, Minneapolis Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00710567
- Sponsor's protocol ID
- DH003
- Status last verified
- Mar 2019
- First submitted
- 2 Jul 2008
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Effectiveness of the DuraHeart™ Left Ventricular Assist System in Patients Awaiting Transplantation
- ClinicalTrials.gov ID
- NCT00710567
- Acronym / sponsor ID
- DH003
- Conditions
- Heart Failure
- Keywords
- Heart Failure, LVAS, LVAD, Rotary Pump
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient enrollment
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Terumo Heart Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2008 (actual)
- Primary completion
- 31 Jan 2012 (actual)
- Study completion
- 12 Nov 2018 (actual)
- First posted
- 4 Jul 2008 (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.
Specific Aims The aims of this trial are to evaluate the safety and effectiveness of the DuraHeart™ LVAS in patients with advanced heart failure who require LVAS support as a bridge to cardiac transplantation.
Study Population The patient population for this trial consists of patients with end stage heart failure awaiting cardiac transplantation. Patients must be listed for transplant with UNOS with status 1A or 1B. All patients who meet the eligibility criteria may be included in the study regardless of gender, race or ethnicity.
Study Design This is a multi-center, prospective, single arm study in which the lower one-sided confidence interval exceeds the performance goal. Enrollment is expected to occur within an 18-month time period at up to 40 centers. All patients will be followed for all endpoints for 6 months while on DuraHeart™ LVAS support, or until cardiac transplantation or death, whichever occurs first. For those patients who remain on support after 180 days, survival and device reliability data will continue to be collected on a regular basis. If patients are transplanted, survival at day 30 post cardiac transplantation will also be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Historical Data | Other | Device: DuraHeart Left Ventricular Assist System (LVAS)DuraHeart Patients will be implanted with a DuraHeart Left Ventricular Assist System (LVAS) as a "bridge to transplant" until a suitable heart can be found as a replacement. Parameters collected will be compared to a performance goal based on historical data for congestive heart failure patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The following are general criteria; more specific conditions are included in the study protocol:
- Approved for cardiac transplantation
- Listed with UNOS on the Status 1 list
- Patient for whom LVAS implantation is planned as a clinically indicated bridge to cardiac transplantation
Key exclusion criteria (6 listed)
- The following are general criteria; more specific conditions are included in the study protocol:
- Contraindication to the administration of warfarin or anti-platelet agents
- Primary coagulopathy or platelet disorder
- Acute myocardial infarction within 48 hours prior to enrollment
- Anticipated need for RVAD support or ECMO at the time of LVAS implantation
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 |
|---|---|---|
| DuraHeart Left Ventricular Assist System (LVAS)Also: LVADThe DuraHeart LVAS is implanted in using open heart surgery | Device | Historical Data |
Primary outcome
Survival to cardiac transplantation or to 180 days post implantation and listed for cardiac transplantation in categories UNOS 1A or 1B.
Time frame: 180 days
Results and safety
The study was stopped early (reason given: Insufficient enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
- Individual participant dataSharing planned: No
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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.
Francis D. Pagani, M.D., Ph.D. principal investigator
University of Michigan
Yoshifumi Naka, M.D., Ph.D. principal investigator
Columbia University
David S Feldman, MD principal investigator
Minneapolis Heart Institute
26 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DuraHeart Left Ventricular Assist System (LVAS) in people with Heart Failure, run by Terumo Heart Inc. at 26 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. 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: stopped early, as of the sponsor's last update on 13 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, Canada. 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.
Are results available for this study?
The study was stopped early (reason given: Insufficient enrollment). 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. (time frame: 180 days). 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 13 Dec 2019.