Non Interventional Study on Pulmonary Valve Replacement by Thranscatheter Pulmonary Valve Melody™

Study Overview
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Brief Summary
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Prospective, longitudinal, open-label, multicentre, observational, non-comparative national study using an exhaustive registry of implantations over a given period. This study is requested by French Health Authorities for reimbursement renewal, to maintain reimbursement for pulmonary valvular replacement by bioprothesis in approved indication in France.

Detailed Description
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This is a prospective, longitudinal, open-label, multicentre, observational, non-comparative national study using an exhaustive registry of implantations over a given period in France. The study is requested by French Health Authorities in 2010 for reimbursement renewal, to maintain reimbursement for pulmonary valvular replacement by bioprothesis in approved indication in France. The study was closed in 2013.

Official Title
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Non Interventional Study on Pulmonary Valve Replacement by Thranscatheter Pulmonary Valve Melody™

Conditions
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Right Ventricular Congenital Cardiopathies

Intervention / Treatment
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* Device: Melody valve implantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients requiring pulmonary valvular replacement for correction of right ventricular ejection path malfunction (stenosis and/or pulmonary regurgitation). Exclusion Criteria: Patient or legal representative refusal to data collection or processing Patient unable to guarantee follow-up data collection, in particular for patients living abroad
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 |
| --- | --- |
| Patients implanted with Medtronic Melody valve<br>All patients that received a valve implantation were included in the registry. | Device: Melody valve implantation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| absence of re-intervention on the pulmonary valve | to evaluate the efficacy of the MELODY valve, defined as the absence of re-intervention on the pulmonary valvee | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate re-intervention on the valve | To document the rate re-intervention on the valve during a 60 months follow-up after its implantation | 60 months | 
| time period before re-intervention on the valve | To document the time period before re-intervention on the valve (longevity of the prosthesis), the reasons for re-intervention (stent fracture, leak, stenosis) and the rate of durability (% of implanted valves with malfunction requiring a re-intervention) | 60 months | 
| patient characteristics | To compare the patient characteristics to the indications of the bioprosthesis | 60 months | 
| Description and time of onset of open surgery after implantation | Description and time of onset of open surgery after implantation on first implanted patients versus device replacement | 60 months | 
| failures of the implantation procedure | To document the failures of the implantation procedure | 60 months | 
| survival rate at 12, 36, 48 and 60 months | To document the survival rate at 12, 36, 48 and 60 months | 60 months | 
| frequency of antiplatelet treatment during and after implant | To describe the frequency of antiplatelet treatment during and after implant | 60 months | 
| patients' characteristics to indications of the MELODY™ bioprosthesis | To compare patients' characteristics to indications of the MELODY™ bioprosthesis | 60 months | 
| time period before the resumption of professional, university or scholastic activity | To document the time period before the resumption of professional, university or scholastic activity | 60 months |