Thoratec HeartMate II Left Ventricular Assist System (LVAS) for Bridge to Cardiac Transplantation
Public ClinicalTrials.gov record NCT00121472. 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, Bridge to Cardiac Transplantation
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 a bridge to cardiac transplantation in end-stage heart failure patients who are listed for cardiac transplant but are at imminent risk of dying. The HeartMate II LVAS was approved by the US FDA on April 21, 2008, as a bridge to cardiac transplantation (reference PMA P060040). It was approved for commercial distribution in Canada on May 20, 2009 (reference Medical Device Licence #79765). Patients enrolled into the clinical trial will continue to be followed until all have reached a clinical outcome.
Study identification
- NCT ID
- NCT00121472
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 194 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- Not listed
- 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
- Mar 2005 (Type not available)
- Primary completion
- Nov 2006 (Actual)
- Completion
- May 2010 (Actual)
- Last update posted
- Jun 27, 2022
2005 – 2010
United States locations
- U.S. sites
- 34
- U.S. states
- 24
- U.S. cities
- 33
| 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 | — |
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | — |
| Shands Hospital @ University of Florida | Gainesville | Florida | 32610 | — |
| Methodist Hospital | Indianapolis | Indiana | 46206 | — |
| Jewish Hospital | Louisville | Kentucky | 40202 | — |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| Barnes-Jewish Hospital/Washington University | St Louis | Missouri | 63110 | — |
| 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 | — |
| 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 | 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 NCT00121472, 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 22, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00121472 live on ClinicalTrials.gov.