Syncardia 50cc TAH-t as a Bridge to Transplant
Public ClinicalTrials.gov record NCT02459054. 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
SynCardia 50cc Temporary Total Artificial Heart (TAH-t) as a Bridge to Transplant
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of the study is to evaluate whether the 50cc TAH-t can safely support, and provide probable benefit to, transplant-eligible pediatric patients (aged 10 - 18 years) and can safely and effectively support transplant-eligible adult patients (aged 19 - 75 years) at imminent risk of death from biventricular failure without experiencing permanent disabling, stroke-related deficits. The study will be conducted as a three-arm trial of the 50cc temporary Total Artificial Heart (TAH-t) as a bridge to transplant: * The Primary Pediatric Arm of the trial will evaluate the safety and probable benefit of the 50cc TAH-t for transplant-eligible patients 10 through 18 years of age. * The Primary Adult Arm of the trial will evaluate the safety and efficacy of the 50cc TAH-t for transplant-eligible patients 19 through 75 years of age. * The Secondary Arm will capture pediatric and adult subjects who did not meet enrollment criteria for a Primary Arm, but meet the less restrictive Secondary Arm enrollment criteria, in order to further characterize the use of the device.
Study identification
- NCT ID
- NCT02459054
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 16 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 10 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
- Oct 2015 (Actual)
- Primary completion
- Jul 29, 2020 (Actual)
- Completion
- Jul 29, 2020 (Actual)
- Last update posted
- Aug 10, 2020
2015 – 2020
United States locations
- U.S. sites
- 26
- U.S. states
- 14
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Banner University Medical Center | Tucson | Arizona | 85724 | — |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | — |
| University of California Los Angeles | Los Angeles | California | 90095 | — |
| Shands Hospital at the University of Florida | Gainesville | Florida | 32610 | — |
| Indiana University Health | Indianapolis | Indiana | 46202 | — |
| Riley Hospital for Children at Indiana University Health | Indianapolis | Indiana | 46202 | — |
| University of Louisville | Louisville | Kentucky | 40202 | — |
| Ochsner Medical Center | New Orleans | Louisiana | 70121 | — |
| Strong Memorial Hospital - Paul Yu Heart Center | Rochester | New York | 14642 | — |
| Cincinnati Children's Hospital | Cincinnati | Ohio | 45229 | — |
| The Ohio State University | Columbus | Ohio | 43210 | — |
| Integris Baptist Medical Center | Oklahoma City | Oklahoma | 73112 | — |
| The Milton S Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | — |
| Children's Health of Dallas | Dallas | Texas | 75235 | — |
| Baylor University Medical Center at Dallas | Dallas | Texas | 75246 | — |
| Memorial Hermann Hospital | Houston | Texas | 77030 | — |
| Methodist DeBakey Heart and Vascular Center | Houston | Texas | 77030 | — |
| University of Virginia Medical Center | Charlottesville | Virginia | 22903 | — |
| Virginia Commonwealth University | Richmond | Virginia | 90048 | — |
| University of Washington Medical Center | Seattle | Washington | 98195 | — |
| Providence Sacred Heart Medical Center | Spokane | Washington | 99204 | — |
| Aurora St. Luke's Hospital | Milwaukee | Wisconsin | 53215 | — |
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
| Froedtert & the Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
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 NCT02459054, 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 Aug 10, 2020 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02459054 live on ClinicalTrials.gov.