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NCT02555319

A Feasibility Study to Evaluate the Safety and Short-term Effectiveness of Transcatheter Pulmonary Valve (TPV)

Completed NA Last updated 6 February 2023
What this trial tests

NA trial testing Transcatheter Pulmonary Valve (TPV) in Congenital Heart Defects in 10 participants. Completed in 25 October 2021.

Timeline
26 August 2015
Primary endpoint
14 April 2017
25 October 2021

Quick facts

Lead sponsorSeoul National University Hospital
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment10
Start date26 August 2015
Primary completion14 April 2017
Estimated completion25 October 2021
Sites1 location across South Korea

Drugs / interventions tested

Conditions studied

Sponsor

Seoul National University Hospital

Who can join

10 and older, any sex, with Congenital Heart Defects or Cardiovascular Abnormalities. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to evaluate the safety and short-term effectiveness of implantation of Transcatheter Pulmonary Valve (TPV) for the treatment of congenital heart disease with pulmonary valve disease.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Successful Feasibility Human Trial of a New Self-Expandable Percutaneous Pulmonary Valve (Pulsta Valve) Implantation Using Knitted Nitinol Wire Backbone and Trileaflet α-Gal-Free Porcine Pericardial Valve in the Native Right Ventricular Outflow Tract.
    Kim GB, Song MK, Bae EJ, Park EA, et al · · 2018 · cited 47× · PMID 29871940 · DOI 10.1161/circinterventions.118.006494

Verify or expand the search:

Other recruiting trials for Congenital Heart Defects

Currently open trials in the same condition.

Other Seoul National University Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02555319.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing