Assess Safety and Probable Benefit of the EXCOR® Pediatric Ventricular Assist Device
Public ClinicalTrials.gov record NCT00583661. 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
A Prospective, Multi-center, Single Arm Study to Access the Safety and Probable Benefit of the Berlin Heart EXCOR® Pediatric Ventricular Assist Device [EXCOR Pediatric]
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of the study is to determine whether use of the Berlin Heart EXCOR® Pediatric Ventricular Assist Device for bridge-to-transplant is associated with a reasonable assurance of safety and probable benefit such that the EXCOR® Pediatric merits approval by the Food and Drug Administration under a Humanitarian Device Exception (HDE).
Study identification
- NCT ID
- NCT00583661
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 48 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 1 Day to 16 Years
- 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
- May 2007 (Type not available)
- Primary completion
- Sep 2010 (Actual)
- Completion
- Dec 2011 (Actual)
- Last update posted
- Mar 15, 2013
2007 – 2011
United States locations
- U.S. sites
- 15
- U.S. states
- 15
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202 | — |
| Lucille Packard Children's Hospital / Stanford University | Palo Alto | California | 94304 | — |
| The Children's Hospital Denver | Denver | Colorado | 80045 | — |
| Children's Healthcare of Atlanta | Atlanta | Georgia | 30322 | — |
| Riley Hospital for Children | Indianapolis | Indiana | 26202 | — |
| Children's Hospital of Boston | Boston | Massachusetts | 02115 | — |
| C.S. Mott Children's Hospital | Ann Arbor | Michigan | 48109 | — |
| University of Minnesota - Fairview | Minneapolis | Minnesota | 55455 | — |
| St. Louis Children's Hospital | St Louis | Missouri | 63110 | — |
| The Mt. Sinai Hospital | New York | New York | 10029 | — |
| Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | — |
| Texas Children's Hospital | Houston | Texas | 77030 | — |
| Seattle Children's Hospital | Seattle | Washington | 98105 | — |
| Children's Hospital 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.
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 NCT00583661, 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 Mar 15, 2013 · Synced Oct 29, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00583661 live on ClinicalTrials.gov.