ALTERRA Post-Approval Study
Public ClinicalTrials.gov record NCT05378386. 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
Multicenter Post-Approval Study of Congenital Pulmonic Valve Dysfunction Studying the Edwards SAPIEN 3 Transcatheter Pulmonary Valve System With Alterra Adaptive Prestent
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will monitor device performance and outcomes in subjects undergoing implantation of the Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent in the post-approval setting
Study identification
- NCT ID
- NCT05378386
- Recruitment status
- Active, not recruiting
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 150 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
- May 12, 2022 (Actual)
- Primary completion
- Sep 25, 2025 (Actual)
- Completion
- Jul 2035 (Estimated)
- Last update posted
- Oct 5, 2026
2022 – 2035
United States locations
- U.S. sites
- 23
- U.S. states
- 16
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's of Alabama | Birmingham | Alabama | 35233 | — |
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202 | — |
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | — |
| Rady Children's Hospital | San Diego | California | 92123 | — |
| Stanford University | Stanford | California | 94305 | — |
| Colorado Children's Hospital | Aurora | Colorado | 80045 | — |
| UF Health Shands Hospital | Gainesville | Florida | 32669 | — |
| St. Joseph's Children's Hospital | Tampa | Florida | 33607 | — |
| Advocate Children's Hospital | Oak Lawn | Illinois | 60453 | — |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | — |
| Washington University in St. Louis | St Louis | Missouri | 63130 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| Columbia University | New York | New York | 10032 | — |
| Duke University | Durham | North Carolina | 27710 | — |
| Cincinnati Children's Hospital | Cincinnati | Ohio | 45229 | — |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | — |
| UPMC Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | — |
| Le Bonheur Children's Hospital | Memphis | Tennessee | 38103 | — |
| Medical City Dallas | Dallas | Texas | 75230 | — |
| Children's Memorial Hermann Hospital | Houston | Texas | 77030 | — |
| Texas Children's Hospital | Houston | Texas | 77030 | — |
| Primary Children's Hospital | Salt Lake City | Utah | 84113 | — |
| Seattle Children's Hospital | Seattle | Washington | 98105 | — |
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 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05378386, 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 Oct 5, 2026 · 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 NCT05378386 live on ClinicalTrials.gov.