Clinical Trial

Xeltis Bioabsorbable Pulmonary Valved Conduit Pivotal Study

Study acronym: Xplore2
Active, Not Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 1 change
notable Enrollment reduced: 56 -> 6 participants 2026-08-07
Trial Details
NCT Number NCT03022708
Lead Sponsor Xeltis
Conditions Heart Defect, Congenital
Enrollment 6 participants
Start Date 2017-05-08
Primary Completion 2022-12-15 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-08-06