Thoratec HeartMate II Left Ventricular Assist System (LVAS) for Destination Therapy
Public ClinicalTrials.gov record NCT00121485. 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
The HeartMate II LVAS Pivotal Study Protocol, Destination Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to determine the safety and effectiveness of the Thoratec HeartMate II Left Ventricular Assist System (LVAS) as Destination Therapy in end-stage heart failure patients who do not qualify for cardiac transplantation. The Destination Therapy indication for use was approved by FDA on January 20, 2010 (ref. PMA P060040/S005).
Study identification
- NCT ID
- NCT00121485
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 200 participants
Conditions and interventions
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
- Feb 2005 (Type not available)
- Primary completion
- Jun 2009 (Actual)
- Completion
- Jan 2012 (Actual)
- Last update posted
- Jun 27, 2022
2005 – 2012
United States locations
- U.S. sites
- 45
- U.S. states
- 28
- U.S. cities
- 40
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | — |
| Mayo Clinic Hospital | Phoenix | Arizona | 85054 | — |
| Sharp Memorial Hospital | San Diego | California | 92123 | — |
| California Pacific Medical Center | San Francisco | California | 94115 | — |
| University of Colorado Hospital | Denver | Colorado | 80262 | — |
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | — |
| Shands Hospital @ University of Florida | Gainesville | Florida | 32610 | — |
| Tampa General Hospital | Tampa | Florida | 33606 | — |
| Emory University Hospital | Atlanta | Georgia | 30322 | — |
| Advocate Christ Medical Center | Oak Lawn | Illinois | 60453 | — |
| Methodist Hospital | Indianapolis | Indiana | 46206 | — |
| Jewish Hospital | Louisville | Kentucky | 40202 | — |
| University of Maryland School of Medicine | Baltimore | Maryland | 21201 | — |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | — |
| Tufts / New England Medical Center | Boston | Massachusetts | 02111 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Brigham & Women's Hospital | Boston | Massachusetts | 02115 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Barnes-Jewish Hospital/Washington University | St Louis | Missouri | 63110 | — |
| Bryan LGH Heart Institute | Lincoln | Nebraska | 68516 | — |
| Newark Beth Israel Medical Center | Newark | New Jersey | 07112 | — |
| New York Columbia Presbyterian Medical Center | New York | New York | 10032 | — |
| University of Rochester | Rochester | New York | 14642 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Ohio State University | Columbus | Ohio | 43212 | — |
| INTEGRIS Baptist Medical Center | Oklahoma City | Oklahoma | 73112 | — |
| Milton Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| Hahnemann University Hospital | Philadelphia | Pennsylvania | 19102 | — |
| Hospital of University of PA | Philadelphia | Pennsylvania | 19104 | — |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | — |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | — |
| Baptist Memorial Hospital | Memphis | Tennessee | 38120 | — |
| Medical City Hospital Dallas | Dallas | Texas | 75230 | — |
| Texas Heart Institute | Houston | Texas | 77030 | — |
| LDS Hospital (Intermountain Health Care) | Salt Lake City | Utah | 84143 | — |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23510 | — |
| University of Washington | Seattle | Washington | 98195 | — |
| Sacred Heart Medical Center | Spokane | Washington | 99204 | — |
| University of Wisconsin Medical School | Madison | Wisconsin | 53792 | — |
| 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 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00121485, 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 Jun 27, 2022 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00121485 live on ClinicalTrials.gov.