Harmony TPV Post-Approval Study

Study Overview
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Brief Summary
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The purpose of this study is to characterize the functionality of transcatheter implantation of the Medtronic Harmony Transcatheter Pulmonary Valve (TPV) achieved by real-world implanters.

Official Title
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Harmony TPV Post-Approval Study (Harmony PAS2)

Conditions
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Congenital Heart Disease, Tetrology of Fallot, RVOT Anomaly, Pulmonary Regurgitation

Intervention / Treatment
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* Device: Harmony TPV System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient eligible to receive the Harmony TPV, meeting the indications for use criteria per current geography-specific device labeling at time of study enrollment Patient (or patient's legally authorized representative) is willing to consent to participate in the study Exclusion Criteria: Anatomy unable to accommodate a 25 Fr delivery catheter system Obstruction of the central veins Clinical or biological signs of infection including active endocarditis Planned concomitant branch pulmonary artery stenting at time of implant Positive pregnancy test at baseline (prior to CT angiography and again prior to implant procedure) in female subjects of childbearing potential Patients with right ventricular outflow tract obstruction (RVOTO) lesions surgically treated with an RV-PA conduit implant 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 Planned implantation of the Harmony TPV in the left heart Known allergy to aspirin, heparin, or nickel Echocardiographic evidence of intracardiac mass, thrombus, or vegetation Pre-existing prosthetic heart valve or prosthetic ring in any position
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: Harmony TPV System<br>Intervention Device: Harmony Transcatheter Pulmonary Valves and Delivery System | Device: Harmony TPV System<br>* Harmony Transcatheter Pulmonary Valve (sizes 22 mm and 25 mm) and Harmony Delivery Catheter System (DCS)<br>* Other names: Model Numbers: HARMONY-22, HARMONY-25, and HARMONY-DCS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects without valve reintervention and with acceptable hemodynamic function composite at 6 months as defined by: | Mean RVOT gradient as measured by continuous-wave Doppler echocardiography ≤40 mmHg AND Pulmonary regurgitant fraction as measured by CMR <20% | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects free from all-cause mortality at 6-months | Described by Kaplan-Meier statistics at 6-months. | 6 months | 
| Percentage of subjects free from reoperation at 6-months | Described by Kaplan-Meier statistics at 6-months. | 6 months | 
| Percentage of subjects free from catheter reintervention at 6-months | Described by Kaplan-Meier statistics at 6-months. | 6 months | 
| Percentage of subjects free from TPV dysfunction at 6-months | Described by Kaplan-Meier statistics at 6-months. | 6 months | 
| Number and percentage of subjects with procedure success at 30-days |  | 30-days | 
| Number and percentage of subjects with serious device-related adverse events at 6 months | Also described with Kaplan-Meier method for AEs of clinical interest. | 6 months |