PULSTA Transcatheter Pulmonary Valve Pre-Approval Study

Summary

The purpose of the study is to evaluate the safety and effectiveness of the PULSTA Transcatheter Pulmonary Valve (TPV) System for the treatment of congenital or acquired pulmonary valve stenosis and/or regurgitation who require pulmonary valve replacement.

Conditions

• Heart Diseases
• Pulmonary Valve Regurgitation
• Pulmonary Valve Stenosis
• Tetralogy of Fallot

Interventions

DEVICE

PULSTA TPV System

PULSTA transcatheter pulmonary valve replacement.

Sponsors & Collaborators

• Avania

  collaborator INDUSTRY

• Taewoong Medical Co., Ltd.

  lead INDUSTRY

Principal Investigators

• Mario Carminati, PhD. MD. · Policlinico San Donato

• Stanimir Georgiev, PhD. MD. · Deutsches Herzzentrum Munchen

• Jose Luis Zunzunegui, PhD. MD. · Gregorio Marañon hospital

• Federico Gutierrez Larraya, PhD. MD. · Hospital Universitario La Paz

• Ender Odemis, PhD. MD. · Koc University Hospital

• Ahmet Çelebi, PhD. MD. · Siyami Ersek Hospital

• Gregor Krings, PhD. MD. · Utrecht University Wilhelmina

• Thomas Krasemann, PhD. MD. · Erasmus Medical Center

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

• Jae Young Choi, PhD. MD. · Severance Hospital

• Seong Ho Kim, PhD. MD. · Sejong General 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

2019-10-07

Primary Completion

2022-09-21

Completion

2026-12-31

Countries

• Germany
• Italy
• Netherlands
• South Korea
• Spain
• Turkey (Türkiye)

Study Locations