Pulmonic SAPIEN S3™ THV Registry

Study Overview
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Brief Summary
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Multi-center, Observational Registry with Retrospective Enrollment and Prospective Follow-up. The aim of the registry is to document the feasibility and safety of implanting an Edwards SAPIEN S3 transcatheter heart valve in the pulmonic position

Detailed Description
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A malfunction or dysplasia of the pulmonary valve or the right ventricular outflow tract (RVOT) is one of the major components of the cardiac physiology in many congenital heart defects. Surgical correction of complex heart defects often includes some form of surgical repair or replacement of the native RVOT by biological valves such as homograft, bioprosthesis or Xenografts (i.e., Contegra conduits). Typical examples are tetralogy of Fallot (TOF) or double outlet right ventricle (DORV), pulmonary stenosis (PS), pulmonary atresia (PA), truncus arteriosus (TA), transposition of the great arteries (TGA) with PS (Rastelli's operation), absent pulmonary valve syndrome (Miller-Lev-Paul), Ross surgery for aortic valve disease and others. The repaired or replaced pulmonary valve however often becomes dysfunctional later on and many patients require surgical revisions of the RVOT with pulmonary valve replacement within 10 years of primary intervention. TPVI provides a less invasive alternative to surgery in patients with right ventricular-to-pulmonary artery (RV-PA) conduit dysfunction. Early results of percutaneous pulmonary valve implantation (PPVI) showed that it is a promising procedure compared to a conventional surgical intervention. Meanwhile, pre-stenting of the RVOT before PPVI is routinely performed, enabling PPVI in various anatomies.

Official Title
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Pulmonic SAPIEN S3™ THV Registry A Multi-center, Observational Registry With Retrospective Enrollment of Patients That Underwent Transcatheter Pulmonic Valve Implantation and a Retrospective or Prospective Follow-up

Conditions
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Pulmonary Valve Malfunction, Right Ventricular Outflow Tract (RVOT) Dysfunction

Intervention / Treatment
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* Other: Sapien S3


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Clinical indication and decision for the implantation of an Edwards SAPIEN 3 THV made Data release form Exclusion Criteria: none
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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| pulmonary valve replacement<br>SAPIEN S3 Transcatheter Heart Valve in the pulmonic position at the time of data collection | Other: Sapien S3<br>* Patients that have undergone percutaneous implantation of an Edwards SAPIEN S3 Transcatheter Heart Valve in the pulmonic position at the time of data collection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in right ventricular and pulmonary artery pressure |  | from baseline to 30 days after implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Max. flow velocity RVOT |  | 30 days after implantation | 
| Changes in NYHA class |  | from baseline to 30 days after implantation | 
| changes in degree of pulmonary regurgitation |  | from baseline to 30 days after implantation | 
| length of hospitalization |  | 30 days after implantation | 
| changes in Peak Oxygen consumption |  | from baseline to 24 months after implantation | 
| Percentage of cases with proper device function |  | 24 months after implantation | 
| Incidence of structural valve Deterioration including stent fracture |  | 24 months after implantation |