Melody® Transcatheter Pulmonary Valve Post-Approval Study

Study Overview
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Brief Summary
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The purpose of this study is to confirm the short-term hemodynamic effectiveness results achieved by real-world providers are equivalent to the historical control established in the IDE study.

Official Title
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Implantation of the Medtronic Melody Transcatheter Pulmonary Valve (TPV) in Patients With Dysfunctional Right Ventricular Outflow Tract (RVOT) Conduits: A Post-Market Approval Study

Conditions
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Dysfunctional Right Ventricular Outflow Tract (RVOT) Conduit

Intervention / Treatment
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* Device: Melody® Transcatheter Pulmonary Valve


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Existence of a full (circumferential) RVOT conduit that was equal to or greater than 16 mm in diameter when originally implanted Dysfunctional RVOT conduits with a clinical indication for intervention (regurgitation ≥ moderate regurgitation, Stenosis: mean RVOT gradient ≥ 35 mmHg) Exclusion Criteria: Implantation in the aortic or mitral position Venous anatomy unable to accommodate a 22-fr size introducer sheath Obstruction of the central veins Clinical or biological signs of infection including active endocarditis Unwilling or unable to provide written informed consent or comply with the follow-up requirements
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 RVOT Conduit. | Device: Melody® Transcatheter Pulmonary Valve<br>* Transcatheter Pulmonary Valve replacement Transcatheter valve implantation into a RVOT conduit in patients with complex congenital heart defects where the conduit has become dysfunctional and where the patient needs invasive intervention.<br>* Other names: Melody Transcatheter Pulmonary Valve;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptable TPV Hemodynamic Function at Six Months After Successful TPV Implantation | Acceptable TPV hemodynamic function at six months after successful TPV implantation is determined as a composite of the following: Mean RVOT gradient is less than or equal to 30 mmHg as measured by CW Doppler, and Severity of pulmonary regurgitation is less than moderate by Doppler echocardiography, and Free from RVOT conduit reoperation or catheter re-intervention at six months after TPV implantation. The endpoint is defined as the percentage of subjects with acceptable TPV hemodynamic function at six months after Melody valve implantation. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural Success | Procedural success is defined as a composite of the following: The TPV is fixated within the desired location, and The RV-PA peak-to-peak gradient measured in the catheterization lab after TPV implantation is less than 35 mmHg, and There is no more than trivial pulmonary regurgitation by angiography The subject is free from explantation of the TPV at 24 hours post-implant | 6 Months | 
| Serious Procedural Adverse Events | A procedure-related event is defined as an event that is associated with the implant procedure by the chronology or physiology and was caused by the implant procedure (e.g. rupture of the conduit or damage to an intra-cardiac or intravascular structure by the delivery system). | 6 Months | 
| Serious Device-related Adverse Events | A device-related event is defined as an event that is associated with the TPV by the chronology or physiology and was caused by the the TPV (e.g. embolization of the TPV and any adverse events which follow). | 6 months | 
| Changes in NYHA Functional Classification | Change in NYHA functional class from pre-implant to 6 month post-implant | 6 Months |