Xeltis Bioabsorbable Pulmonary Valved Conduit Pivotal Study
Public ClinicalTrials.gov record NCT03022708. 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
Prospective, Non-randomized, Pivotal Study to Assess the Safety and Efficacy of the Bioabsorbable Pulmonary Valved Conduit in Subjects Undergoing Right Ventricular Outflow Tract (RVOT) Reconstruction
Study identification
- NCT ID
- NCT03022708
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Lead sponsor
- Xeltis
- Industry
- Enrollment
- 56 participants
Conditions and interventions
Conditions
Interventions
- Xeltis Bioabsorbable Pulmonary Valved Conduit Device
Device
Eligibility (public fields only)
- Age range
- 2 Years to 21 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 7, 2017
- Primary completion
- Dec 14, 2022
- Completion
- Nov 30, 2026
- Last update posted
- Jul 21, 2025
2017 – 2026
United States locations
- U.S. sites
- 7
- U.S. states
- 7
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Hospital of Los Angeles | Los Angeles | California | 90027 | — |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | — |
| Joe DiMaggio Children's Hospital | Hollywood | Florida | 33021 | — |
| New York Presbyterian Hospital - Columbia University (Xplore1) | New York | New York | 10032 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | — |
| Children's Hospital of Pittsburgh of UPMC (Xplore1) | Pittsburgh | Pennsylvania | 15224 | — |
| UTSW- Dallas Children's Hospital | Dallas | Texas | 75390-8835 | — |
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 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03022708, 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 Jul 21, 2025 · Synced Jul 21, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03022708 live on ClinicalTrials.gov.