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Xeltis Pulmonary Valved Conduit Safety and Performance Study

NCT03405636 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-04-09

No results posted yet for this study

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

  • Heart Defects, Congenital

Interventions

DEVICE

Xeltis Pulmonary Valved Conduit

RVOT reconstruction

Sponsors & Collaborators

  • Xeltis

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-30
Primary Completion
2021-10-31
Completion
2026-10-31

Countries

  • Hungary
  • Malaysia
  • Poland
  • Slovakia

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 NCT03405636 on ClinicalTrials.gov