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Pulsta® Transcatheter Pulmonary Valve Korean Multicenter Study

NCT03110861 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-09-04

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and effectiveness of the TPV in patients with pulmonary valve dysfunction.

Conditions

  • Congenital Heart Defect
  • Pulmonary Valve; Insufficiency, Congenital
  • Pulmonary Valve Stenosis

Interventions

DEVICE

Pulsta® Transcatheter Pulmonary Valve (TPV) Replacement

Pulsta® Transcatheter Pulmonary Valve Replacement

Sponsors & Collaborators

  • Taewoong Medical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Gi Beom Kim, phD. MD. · Seoul National University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-22
Primary Completion
2019-11-06
Completion
2024-07-12

Countries

  • South Korea

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 NCT03110861 on ClinicalTrials.gov