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NCT03022708 · ClinicalTrials.gov registry record · NA
Xeltis Bioabsorbable Pulmonary Valved Conduit Pivotal Study
A NA study of Heart Defect, Congenital, sponsored by Xeltis.
- Active
- Registry status
- NA
- Development phase
- 56
- Enrollment target
- 10
- Study locations
NCT03022708: Active NA study of Heart Defect, Congenital, sponsored by Xeltis.
NCT03022708 is a NA study of Heart Defect, Congenital that is active but no longer recruiting, run by Xeltis. The registered enrollment target is 56 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). The trial reports 10 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03022708, a NA study of Heart Defect, Congenital, is active but no longer recruiting, sponsored by Xeltis.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 56 participants
- Enrollment target
- 10
- Study locations
Study Summary
This is a multi-center prospective, single-arm, non-randomized, pivotal study that will continue to access the feasibility of the Xeltis Bioabsorbable Pulmonary Valved Conduit in subjects requiring right ventricular outflow tract correction or reconstruction due to congenital heart malformations.
Primary Outcome
Measured once all 12 month follow up visits have been completed
Conditions Studied
Interventions
- DEVICE Xeltis Bioabsorbable Pulmonary Valved Conduit
Study Locations (10)
Other
- Multiprofile Hospital for Active Treatment "National cardiology hospital" EAD, Department of Congenital Heart Defects Surgery - Sofia
- Institut Jantung Negara Sdn Bhd - Kuala Lumpur
- University Children's Hospital of Cracow - Krakow
California
- Children's Hospital of Los Angeles - Los Angeles
Colorado
- Children's Hospital Colorado - Aurora
Florida
- Joe DiMaggio Children's Hospital - Hollywood
New York
- New York Presbyterian Hospital - Columbia University (Xplore1) - New York
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Pennsylvania
- Children's Hospital of Pittsburgh of UPMC (Xplore1) - Pittsburgh
Texas
- UTSW- Dallas Children's Hospital - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2017-05-08 |
| Est. Completion | 2026-12 |
| Phase | NA |
What the registry record for NCT03022708 still lists
NCT03022708 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Heart Defect, Congenital appearing as the primary indexed condition, and to 1 intervention - of which Xeltis Bioabsorbable Pulmonary Valved Conduit is the first listed.
NCT03022708 lists 10 locations in 8 states (Other, California, Colorado).
Frequently Asked Questions
What is clinical trial NCT03022708 about?
NCT03022708 is a clinical study titled "Xeltis Bioabsorbable Pulmonary Valved Conduit Pivotal Study". This is a multi-center prospective, single-arm, non-randomized, pivotal study that will continue to access the feasibility of the Xeltis Bioabsorbable Pulmonary Valved Conduit in subjects requiring right ventricular outflow tract correction or reconstruction due to congenital heart malformations.
What is the current status of trial NCT03022708?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 56 participants. The study started on 2017-05-08. Estimated completion is 2026-12.
What conditions does trial NCT03022708 study?
This clinical trial studies the following conditions: Heart Defect, Congenital.
What interventions are being tested in trial NCT03022708?
The interventions under investigation include: Xeltis Bioabsorbable Pulmonary Valved Conduit (DEVICE).
Who is sponsoring clinical trial NCT03022708?
This trial is sponsored by Xeltis, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03022708 being conducted?
This trial has 10 study locations across California, Colorado, Florida, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03022708's enrollment target sits among peer trials
56 1262nd of 2000 higher than 737 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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