Trials / Active Not Recruiting
Active Not RecruitingNCT03022708
Xeltis Bioabsorbable Pulmonary Valved Conduit Pivotal Study
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
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 56 (estimated)
- Sponsor
- Xeltis · Industry
- Sex
- All
- Age
- 2 Years – 21 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Xeltis Bioabsorbable Pulmonary Valved Conduit | Surgical implantation of Xeltis Bioabsorbable Pulmonary Valved Conduit |
Timeline
- Start date
- 2017-05-08
- Primary completion
- 2022-12-15
- Completion
- 2026-12-01
- First posted
- 2017-01-16
- Last updated
- 2025-07-22
Locations
10 sites across 4 countries: United States, Bulgaria, Malaysia, Poland
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03022708. Inclusion in this directory is not an endorsement.