Pulsta® Transcatheter Pulmonary Valve Korean Multicenter Study

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

Detailed Description
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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.

Official Title
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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

Conditions
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Congenital Heart Defect, Pulmonary Valve; Insufficiency, Congenital, Pulmonary Valve Stenosis

Intervention / Treatment
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* Device: Pulsta® Transcatheter Pulmonary Valve (TPV) Replacement


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pulsta® Transcatheter Pulmonary Valve<br>Pulsta® Transcatheter Pulmonary Valve (TaeWoong Medical Co., Ltd. Korea) | Device: Pulsta® Transcatheter Pulmonary Valve (TPV) Replacement<br>* Pulsta® Transcatheter Pulmonary Valve Replacement<br>|

What is the study measuring?
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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 |