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Xeltis Bioabsorbable Pulmonary Valved Conduit Pivotal Study

NCT03022708 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2025-07-22

No results posted yet for this 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

  • Heart Defect, Congenital

Interventions

DEVICE

Xeltis Bioabsorbable Pulmonary Valved Conduit

Surgical implantation of Xeltis Bioabsorbable Pulmonary Valved Conduit

Sponsors & Collaborators

  • Xeltis

    lead INDUSTRY

Principal Investigators

  • Eliane Schutte · Xeltis Inc

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-08
Primary Completion
2022-12-15
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States
  • Bulgaria
  • Malaysia
  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03022708 on ClinicalTrials.gov