Pulsta® Transcatheter Pulmonary Valve Korean Multicenter Study

A Prospective, Multicenter, Single Arm Study to Evaluate the Safety and Effectiveness of Implantation of 'Transcatheter Pulmonary Valve (TPV)' for the Treatment of Congenital Heart Disease With Pulmonary Valve Disease

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

Study Overview

• Status: Completed
• Conditions: Pulmonary Valve Stenosis; Congenital Heart Defect; Pulmonary Valve; Insufficiency, Congenital
• Intervention / Treatment: Device: Pulsta® Transcatheter Pulmonary Valve (TPV) Replacement

Detailed Description

The TPV is indicated for use in patients with previous undergone replacement of bioprosthetic valve or conduit due to either pulmonary valve atresia, stenosis, regurgitation or a combination of them and present with dysfunctional right ventricular ourflow tract (RVOT) requiring treatment for severe pulmonary regurgitation and/or RVOT conduit obstruction. Consecutive subject data should be collected at discharge, 1, 3, 6 month, and 1-5 years post TPV implantation.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Korea
  • Haehak-ro Jongno-gu
    • Seoul, Haehak-ro Jongno-gu, South Korea, 03080
      • Seoul National University Hospital
  • Hohyun-ro, Sosa-gu
    • Bucheon-si, Hohyun-ro, Sosa-gu, South Korea, 14754
      • Sejong General Hospital
  • Ilwon-ro, Gangnam-gu
    • Seoul, Ilwon-ro, Gangnam-gu, South Korea, 06351
      • Samsung Medical Center
  • Olympic-ro, Songpa-gu
    • Seoul, Olympic-ro, Songpa-gu, South Korea, 05505
      • Asan Medical Center
  • Yonsei-ro, Seodaemun-gu
    • Seoul, Yonsei-ro, Seodaemun-gu, South Korea, 03722
      • Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Body weight greater than or equal to 30 kilograms
• Pulmonary regurgitation ≥moderate pulmonary regurgitation (PR) (≥3+) or RVOT conduit obstruction with mean gradient >35mmHg by echocardiography
• pulmonary artery annulus or in situ conduit size of ≥16 and ≤26mm
• Patient willing to provide written informed consent and comply with follow-up requirements

Exclusion Criteria:

• Pre-existing mechanical heart valve in any position
• Obstruction of the central veins (pulmonic bioprosthesis delivery system to the heart)
• Coronary artery compression
• A known hypersensitivity to Aspirin or Heparin
• Immunosuppressive disease
• Active infectious disease (e.g. endocarditis, meningitis)
• Estimated survival less than 6 months
• Female of child-bearing potential who are unable to take adequate contraceptive precautions, are known to be pregnant, or are currently breastfeeding an infant.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pulsta® Transcatheter Pulmonary Valve; Pulsta® Transcatheter Pulmonary Valve (TaeWoong Medical Co., Ltd. Korea)	Device: Pulsta® Transcatheter Pulmonary Valve (TPV) Replacement; Pulsta® Transcatheter Pulmonary Valve Replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemodynamic functional improvement at 6month	Hemodynamic functional improvement is defined as mean RVOT gradient ≤30 mmHg by continuous wave doppler, and a pulmonary regurgitant fraction <20% by cardiac magnetic resonance (MR).	6 months
Procedural / Device related serious adverse events at 6month		6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural success	Procedural success is defined as the TPV implant within desired position, Right ventricle-Pulmonary artery (RV-PA) peak systolic pressure gradient <35mmHg by catheter, less mild pulmonary regurgitation by angiography, and freedom from explantation of the TPV at 24 hours post-implant.	5 days
Hemodynamic function	Hemodynamic function will be measured including peak RVOT pressure gradient, mean RVOT pressure gradient, RV-PA pressure gradient, RV pressure, cardiac output, cardiac index, RV end-diastolic volume by echocardiography, cardiac MR, or catheterization.	5 years
Severity of pulmonary regurgitation		5 years
New York Heart Association (NYHA) functional classification		5 years
Stent fracture	Stent fracture will be assessed by the investigator through radiography (X-ray, Fluoroscopy).	5 years
Catheter reintervention on TPV		5 years
Reoperation		5 years
Procedural / Device related serious adverse events		5 years
Death (all cause / procedural / device-related)		5 years
Other adverse events		5 years
Pulmonary regurgitant fraction	Pulmonary regurgitant fraction will be measured by cardiac MRI.	6 months

Collaborators and Investigators

• Sponsor: Taewoong Medical Co., Ltd.
• Investigators: Study Chair: Gi Beom Kim, phD. MD., Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2017
• Primary Completion (Actual): November 6, 2019
• Study Completion (Actual): July 12, 2024

Study Registration Dates

• First Submitted: April 7, 2017
• First Submitted That Met QC Criteria: April 7, 2017
• First Posted (Actual): April 12, 2017

Study Record Updates

• Last Update Posted (Estimated): September 4, 2025
• Last Update Submitted That Met QC Criteria: September 2, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Congenital Abnormalities; Cardiovascular Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Defects, Congenital; Pulmonary Valve Stenosis; Surgical Procedures, Operative; Transplantation; Replantation
• Other Study ID Numbers: TPV-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No