Trials / Withdrawn
WithdrawnNCT03405636
Xeltis Pulmonary Valved Conduit Safety and Performance Study
Prospective, Non-randomized, Open Label Clinical Study to Assess the Safety and Performance of the Xeltis Pulmonary Valved Conduit in Subjects Undergoing Right Ventricular Outflow Tract (RVOT) Reconstruction
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Xeltis · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
This is a multi-center prospective, single-arm, non-randomized, open label study to assess safety and performance of the Xeltis 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 Pulmonary Valved Conduit | RVOT reconstruction |
Timeline
- Start date
- 2020-09-01
- Primary completion
- 2021-10-01
- Completion
- 2026-10-01
- First posted
- 2018-01-23
- Last updated
- 2021-04-09
Locations
4 sites across 4 countries: Hungary, Malaysia, Poland, Slovakia
Source: ClinicalTrials.gov record NCT03405636. Inclusion in this directory is not an endorsement.