Pulsta® Transcatheter Pulmonary Valve Korean Multicenter 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.

• Pulsta® Transcatheter Pulmonary Valve (TPV) Replacement (Device): Pulsta® Transcatheter Pulmonary Valve Replacement

Primary outcomes

• Hemodynamic functional improvement at 6month [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).
• Procedural / Device related serious adverse events at 6month [6 months]

Secondary outcomes

• Procedural success [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.
• Hemodynamic function [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.
• Severity of pulmonary regurgitation [5 years]
• New York Heart Association (NYHA) functional classification [5 years]
• Stent fracture [5 years]: Stent fracture will be assessed by the investigator through radiography (X-ray, Fluoroscopy).
• 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 [6 months]: Pulmonary regurgitant fraction will be measured by cardiac MRI.

Sex: All, ages: 10 Years to any

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.

• Gi Beom Kim, phD. MD., Study chair, Seoul National University Hospital