Melody PB1016 Surveillance Study

Study Overview
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Brief Summary
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Non-randomized, multi-center, prospective surveillance study to investigate and assess the residual risks, and to confirm the currently established safety and performance of the Melody TPV PB1016.

Official Title
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Melody(TM) Transcatheter Pulmonary Valve PB1016 Surveillance Study Implantation of the Medtronic Melody Transcatheter Pulmonary Valve PB1016 Using the Ensemble(TM) Transcatheter Delivery System in Patients With Dysfunctional RVOT Conduits

Conditions
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Dysfunctional RVOT Conduits in Patients With Congenital Heart Defects

Intervention / Treatment
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* Device: Melody Transcatheter Pulmonary Valve PB1016


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient eligible to receive Melody TPV PB1016 per current Instructions for Use (IFU) indications at time of study enrollment Patient (or patient's legally authorized representative) is willing to consent to participate in the study and will commit to completion of all follow-up requirements. Exclusion Criteria: Implantation in the aortic, tricuspid, 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 History of intravenous substance abuse Currently participating in an investigational drug or device study
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 |
| --- | --- |
| Other: Melody TPV PB1016<br> | Device: Melody Transcatheter Pulmonary Valve PB1016<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Acceptable TPV Hemodynamic Function At 6 Months | Acceptable TPV hemodynamic function at six months after successful TPV implantation which is determined as a composite of the following: Mean Right Ventricular Outflow Tract (RVOT) gradient is less than or equal to 30 mmHg as measured by Continuous-wave Doppler (CW Doppler) echocardiography, and Severity of pulmonary regurgitation less than moderate by CW Doppler echocardiography, and Free from RVOT conduit reoperation or catheter re-intervention on the TPV at six months post-TPV implantation | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Acceptable TPV Hemodynamic Function At 1 Year | Acceptable TPV hemodynamic function at 1 year after successful TPV implantation which is determined as a composite of the following: Mean RVOT gradient is ≤ 30 mmHg as measured by CW Doppler Severity of pulmonary regurgitation is less than moderate by Doppler echocardiography Free from RVOT conduit reoperation or catheter re-intervention on the TPV at 1 year post-TPV implantation. | 1 Year | 
| Number of Subjects With Acceptable TPV Hemodynamic Function at 2 Years | Acceptable TPV hemodynamic function at 2 years after successful TPV implantation which is determined as a composite of the following: Mean RVOT gradient is ≤ 30 mmHg as measured by CW Doppler Severity of pulmonary regurgitation is less than moderate by Doppler echocardiography Free from RVOT conduit reoperation or catheter re-intervention on the TPV at 2 years post-TPV implantation. | 2 Years | 
| Number of Subjects With Serious Procedure-related and Device-related Adverse Events | Serious procedure-related adverse events at 1year and 2 years post-implant Serious device-related adverse events at 1 year and 2 years post-implant | 1 Year, 2 Years | 
| Number of Subjects With Procedural Success | A successful implant is defined as follows: Melody TPV PB1016 is fixated within the desired location RV-PA peak-to-peak gradient measured in the catheterization lab after Melody TPV PB1016 implantation is < 35 mmHg No more than trace/trivial pulmonary regurgitation by angiography Subject is free from explantation of the Melody TPV PB1016 at 24 hours post-implant. | At Time Of Procedure | 
| Percentage of Participants Who Met Various Safety Parameters of the Melody TPV PB1016 | Kaplan-Meier: Freedom from Stent Fracture Kaplan-Meier: Freedom from re-intervention on the Melody TPV PB1016 Kaplan-Meier: Freedom from RVOT Conduit Operation Kaplan-Meier: Freedom from Death (All-Cause) | 2 years |