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

Study Overview
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Brief Summary
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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.

Detailed Description
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Diverse congenital heart diseases involving the pulmonary artery, such as Tetralogy of Fallot (TOF) with or without pulmonary atresia, or transposition of the great arteries with pulmonary stenosis, require implantation of an artificial conduit between the right ventricle and the pulmonary artery(PA). Because these conduits finally degenerate and result in pulmonary regurgitation and/or stenosis and progressive right ventricle (RV) dilation and eventual failure, patients need repetitive surgery for conduit revision. Transcatheter pulmonary valve implantation (TPVI) is a less invasive alternative to surgery in patients with dysfunctional right ventricular outflow tract (RVOT). TPV is a large-diameter (up to 28 mm) self-expandable stent with a relatively low profile from a nitinol wire backbone with valve leaflets made from porcine pericardial tissue. 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 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 Feasibility Study 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

Conditions
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Congenital Heart Defects, Cardiovascular Abnormalities, Pulmonary Valve Insufficiency, Pulmonary Valve Stenosis

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age greater than or equal to 10 years of age 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 ≥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: Transcatheter Pulmonary Valve<br>Transcatheter Pulmonary Valve (TaeWoong Medical Co., Ltd. Korea) | Device: Transcatheter Pulmonary Valve (TPV)<br>* Transcatheter Pulmonary Valve Replacement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural success | Procedural success is defined as the TPV implant within desired position, 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. | 5day | 
| 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 month | 
| Procedural / Device related serious adverse events at 6month |  | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 year | 
| Severity of pulmonary regurgitation |  | 5year | 
| Pulmonary regurgitant fraction |  | 5year | 
| New York Heart Association (NYHA) functional classification |  | 5 year | 
| Stent fracture |  | 5 year | 
| Catheter reintervention on TPV |  | 5 year | 
| Reoperation |  | 5 year | 
| Procedural / Device related serious adverse events |  | 5 year | 
| Death (all cause / procedural / device-related) |  | 5 year | 
| Other adverse events |  | 5 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary Valve, Transcatheter Pulmonary Valve, Congenital Heart Disease