Evaluation of the HeartWare Left Ventricular Assist Device for the Treatment of Advanced Heart Failure
Public ClinicalTrials.gov record NCT00751972. 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.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate the safety and effectiveness of the HeartWare® LVAD System in patients listed for cardiac transplantation with refractory, advanced heart failure at risk of death. The primary endpoint is survival at 180 days which is defined as alive on the originally implanted HeartWare® LVAD or transplanted or explanted for recovery. Patient must survive 60 days post-explant for recovery to be considered successful. Secondary endpoints include: * Overall survival * Incidence of all serious adverse events, neurocognitive status and unanticipated adverse device effects. * Incidence of all device failures and device malfunctions * Quality of Life improvement, as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) and EuroQoL EQ-5D * Functional status improvement, as measured by the New York Heart Association (NYHA) and 6-minute walk The HeartWare® LVAD System was approved by the US FDA on November 20, 2012 as a bridge to cardiac transplantation (reference PMA P100047). Patients enrolled into this study will be followed to an outcome at six months, and then patients will receive continued follow-up in a separate study.
Study identification
- NCT ID
- NCT00751972
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 140 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
- Aug 2008 (Type not available)
- Primary completion
- Aug 2010 (Actual)
- Completion
- Aug 2013 (Actual)
- Last update posted
- May 30, 2018
2008 – 2013
United States locations
- U.S. sites
- 35
- U.S. states
- 23
- U.S. cities
- 32
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic (Arizona) | Phoenix | Arizona | 85054 | — |
| Sharp Memorial Hospital | San Diego | California | 92123 | — |
| Stanford University School of Medicine | Stanford | California | 94305 | — |
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | — |
| University of Florida Gainesville | Gainesville | Florida | 32610 | — |
| University of Miami / Jackson Memorial Hospital | Miami | Florida | 33136 | — |
| The Emory Clinic | Atlanta | Georgia | 30322 | — |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | — |
| University of Chicago | Chicago | Illinois | 60637 | — |
| Advocate Christ Medical Center | Oak Lawn | Illinois | 60453 | — |
| IU Health Methodist | Indianapolis | Indiana | 46202 | — |
| St. Vincent Health | Indianapolis | Indiana | 46260 | — |
| Jewish Hospital - Rudd Heart and Lung Institute | Louisville | Kentucky | 40202 | — |
| John Ochsner Heart & Vascular Institute | New Orleans | Louisiana | 70115 | — |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | — |
| Tufts Medical Center | Boston | Massachusetts | 02111 | — |
| University of Michigan Hospital | Ann Arbor | Michigan | 48109 | — |
| Henry Ford Hospital | Detroit | Michigan | 48202 | — |
| University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| Mayo Clinic / St. Marys Hospital | Rochester | Minnesota | 55902 | — |
| Washington University / Barnes Jewish Hospital | St Louis | Missouri | 63110 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Cleveland Clinic Foundatiojn | Cleveland | Ohio | 44195 | — |
| Ohio State University Medical Center | Columbus | Ohio | 43210 | — |
| Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | — |
| UT Southwestern Medical Center at Dallas | Dallas | Texas | 75390 | — |
| Texas Heart Institute | Houston | Texas | 77030 | — |
| The Methodist Hospital | Houston | Texas | 77030 | — |
| Intermountain Medical Center | Murray | Utah | 84107 | — |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | — |
| Providence Sacred Heart Medical Center | Spokane | Washington | 99204 | — |
| 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.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00751972, 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 May 30, 2018 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00751972 live on ClinicalTrials.gov.