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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 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. The trial reports 10 study locations across 8 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03022708
The ClinicalTrials.gov registry entry for NCT03022708 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Xeltis, which has 1 total studies on file at ClinicalTrials.gov.
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 reports 10 study locations spanning 8 distinct geographic areas - top geographies include 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.
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Related
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