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Completed

NCT Number: NCT03110861

Pulsta® Transcatheter Pulmonary Valve Korean Multicenter Study

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

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Key information

Conditions

Congenital Heart Defect Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Heart Valve Diseases Pulmonary Valve Stenosis Pulmonary Valve; Insufficiency, Congenital Ventricular Outflow Obstruction

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital, Seoul, Haehak-ro Jongno-gu, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pulsta® Transcatheter Pulmonary Valve (TPV) Replacement

Device

Pulsta® Transcatheter Pulmonary Valve Replacement

Primary outcomes

  1. Hemodynamic functional improvement at 6month

    Time frame: 6 months

    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).

  2. Procedural / Device related serious adverse events at 6month

    Time frame: 6 months

Secondary outcomes

  1. Procedural success

    Time frame: 5 days

    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.

  2. Hemodynamic function

    Time frame: 5 years

    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.

  3. Severity of pulmonary regurgitation

    Time frame: 5 years

  4. New York Heart Association (NYHA) functional classification

    Time frame: 5 years

  5. Stent fracture

    Time frame: 5 years

    Stent fracture will be assessed by the investigator through radiography (X-ray, Fluoroscopy).

  6. Catheter reintervention on TPV

    Time frame: 5 years

  7. Reoperation

    Time frame: 5 years

  8. Procedural / Device related serious adverse events

    Time frame: 5 years

  9. Death (all cause / procedural / device-related)

    Time frame: 5 years

  10. Other adverse events

    Time frame: 5 years

  11. Pulmonary regurgitant fraction

    Time frame: 6 months

    Pulmonary regurgitant fraction will be measured by cardiac MRI.

Sponsors and collaborators

Lead sponsor

Taewoong Medical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2024
First posted
Apr 12, 2017
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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