Evaluation of the Safety and Effectiveness of the DuraHeart™ LVAS
Public ClinicalTrials.gov record NCT00710567. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Evaluation of the Safety and Effectiveness of the DuraHeart™ Left Ventricular Assist System in Patients Awaiting Transplantation
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT00710567
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 66 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 30, 2008
- Primary completion
- Jan 30, 2012
- Completion
- Nov 11, 2018
- Last update posted
- Dec 12, 2019
2008 – 2018
United States locations
- U.S. sites
- 25
- U.S. states
- 15
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35294 | — |
| Mayo Clinic - Phoenix | Phoenix | Arizona | 85054 | — |
| University of Arizona Medical Center | Tucson | Arizona | 85724 | — |
| University of Southern California | Los Angeles | California | 90033 | — |
| Hartford Hospital | Hartford | Connecticut | 06106 | — |
| Yale University | New Haven | Connecticut | 06520 | — |
| University of Miami | Miami | Florida | 33136 | — |
| Tampa General Hospital | Tampa | Florida | 33606 | — |
| St. Joseph's Hospital of Atlanta | Atlanta | Georgia | 30342 | — |
| St. Vincent Hospital | Indianapolis | Indiana | 46260 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Minneapoils Heart Institute Foundation | Minneapolis | Minnesota | 55407 | — |
| Mayo Clinic | Rochester | Minnesota | 55902 | — |
| Newark Beth Israel | Newark | New Jersey | 07112 | — |
| Mt. Sinai School of Medicine | New York | New York | 10029 | — |
| Columbia University | New York | New York | 10032 | — |
| Penn State University | Hershey | Pennsylvania | 17033 | — |
| Temple University | Philadelphia | Pennsylvania | 19140 | — |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | — |
| Medical City | Dallas | Texas | 75230 | — |
| Methodist Hospital | Houston | Texas | 77030 | — |
| Texas Heart Institute | Houston | Texas | 77030 | — |
| Sacred Heart Medical Center | Spokane | Washington | 99204 | — |
| University of Wisconsin | Madison | Wisconsin | 53792 | — |
| Aurora St. Luke's Medical Center | Milwaukee | Wisconsin | 53215 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00710567, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 12, 2019 · Synced Sep 18, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00710567 live on ClinicalTrials.gov.