PULSTA Transcatheter Pulmonary Valve Pre-Approval Study

NAActive, not recruitingINTERVENTIONAL
Enrollment

58

Participants

Timeline

Start Date

October 7, 2019

Primary Completion Date

September 21, 2022

Study Completion Date

December 31, 2026

Conditions
Heart DiseasesPulmonary Valve RegurgitationPulmonary Valve StenosisTetralogy of Fallot
Interventions
DEVICE

PULSTA TPV System

PULSTA transcatheter pulmonary valve replacement.

Trial Locations (11)

3015

Erasmus Medical Center, Rotterdam

3508

Utrecht University Wilhelmina, Utrecht

14754

Sejong General Hospital, Bucheon-si

20097

Policlinico San Donato, Milan

28007

Gregorio Marañon hospital, Madrid

28046

University Hospital La Paz, Madrid

34010

Koc University Hospital, Istanbul

34668

Siyami Ersek Hospital, Istanbul

80636

Deutsches Herzzentrum Munchen, München

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital, Seoul

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Avania

INDUSTRY

lead

Taewoong Medical Co., Ltd.

INDUSTRY