Melody Transcatheter Pulmonary Valve (TPV) Post-Market Surveillance Study

Study Overview
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Brief Summary
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This non-randomized, prospective, interventional observational multi-center study is designed to assess the long-term clinical performance of the Medtronic Melody™ Transcatheter Pulmonary Valve (TPV) in the post market environment over a period of five years after transcatheter implantation in patients with dysfunctional RVOT conduits. In addition, the quality of life of implanted subjects will be assessed over five years.

Official Title
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Melody TPV Post-Market Surveillance Study

Conditions
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Heart Valve Diseases

Intervention / Treatment
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* Device: Melody Transcatheter Pulmonary Valve


Participation Criteria
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Eligibility Criteria
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Prospective subjects have complex congenital heart defects that have been palliated with RVOT conduits that have become dysfunctional and have a clinical indication for invasive intervention. Prospective subjects must meet all of following inclusion and exclusion criteria: Inclusion Criteria: Age greater than or equal to 5 years of age Weight greater than or equal to 30 kilograms Existence of a full (circumferential) RVOT conduit that was equal to or greater than 16 mm in diameter when originally implanted Any of the following by transthoracic echocardiography For patients in NYHA Classification II, III, or IV: Moderate (3+) or severe (4+) pulmonary regurgitation, or Mean RVOT gradient greater than or equal to 35 mmHg. For patients in NYHA Classification I: Severe (4+) pulmonary regurgitation with RV dilatation or dysfunction, or Mean RVOT gradient greater than or equal to 40 mmHg. Exclusion Criteria: Active endocarditis A major or progressive non-cardiac disease (e.g. liver failure, renal failure, cancer) that results in a life expectancy of less than one year Patient or - for patients who cannot legally give consent themselves- the guardian unwilling or unable to provide written informed consent or comply with follow-up requirements Obstruction of the central veins (including the superior and inferior vena cava, bilateral iliac veins) such that the delivery system cannot be advanced to the heart via transvenous approach from either femoral vein or internal jugular vein Known intravenous drug abuse

Ages Eligible for Study
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Minimum Age: 5 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: Melody TPV Implant<br>Melody Transcatheter Pulmonary Valve implanted into a dysfunctional RV-PV conduit. | Device: Melody Transcatheter Pulmonary Valve<br>* Transcatheter valve implantation into a RV-PA conduit in patients with complex congenital heart defects where the conduit has become dysfunctional and where the patient needs intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Performance over five years. Freedom from the following events: * explant * reintervention * stent fracture * valve dysfunction * device or procedure related death |  | August 2014 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural success |  | August 2014 | 
| Incidence of device and procedure related adverse events |  | August 2014 | 
| Hemodynamic Performance |  | August 2014 | 

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