Observational Study of Venus P-Valve

Study Overview
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Brief Summary
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Real-world evidence, prospective, non-randomized, multicenter observational study of Venus P-ValveTM System in treating moderate or greater pulmonary regurgitation with/without pulmonary stenosis in patients with native right ventricular outflow tract (RVOT). All subjects will be followed up through five years for the observed outcome measures, which will be analyzed and reported to regulatory authorities as required. Post-procedure, a clinical visit will be scheduled at discharge, thirty days, six months, one year, and annually thereafter to five years.

Detailed Description
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Clinical assessment at pre- and post-implant, 30 days, 6 months, 1 year and annually thereafter through 5 years (Telehealth follow-up allowed at years 2, 3, 4) CT or MRI at pre-implant (subject screening) Echocardiography at pre-implant, discharge (or 7 days), 30 days, 6 months, and at 1 year and 5 years Bi-plane fluoroscopy at implant and either CT, MRI or chest X-ray at 6 or 12 months NYHA at pre-implant, discharge (or 7 days), 30 days, 6 months, 1 year and annually thereafter through 5 years EQ-5D at pre-implant, 30 days, 6 months, 1 year and annually thereafter through 5 years

Official Title
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Real-World Evidence - An Observational Study of Venus P-ValveTM System in the Treatment of Patients With Native RVOT Dysfunction

Conditions
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Right Ventricular Outflow Tract Dysfunction

Intervention / Treatment
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* Device: transcatheter pulmonary valve implantation (TPVI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Patients with native RVOT (including transvalvular patch repair) are present with moderate or greater pulmonary regurgitation with/without stenosis and are clinically indicated for pulmonary valve intervention. The patient (or the patient's legally authorized representative) is willing to consent to participate in the study and will commit to completing all follow-up requirements. Exclusion Criteria: 1. Patients with any condition contraindicated by the IFU or inability to comply with the Venus P-ValveTM System Instructions for Use or the study protocol. -

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 70 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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: transcatheter pulmonary valve implantation (TPVI)|A stent-mounted valve is introduced over a guidewire and positioned in the RVOT, followed by balloon inflation to deploy the valve.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reintervention | Freedom from Venus P-ValveTM (catheter or surgical) reintervention | at six months | 
| Hemodynamic Function | Acceptable hemodynamic function, defined as: Mild or less regurgitation measured by echocardiography; AND Mean RVOT gradient as measured by echocardiography ≤35mmHg. | at six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural Success | Procedure success at 30 days, defined as: Freedom from procedure/device-related mortality Freedom from Venus P-ValveTM (catheter or surgical) reintervention concerning index procedure or device Acceptable hemodynamic function Original intended valve in situ | at 30 days | 
| Occurrence of Events | Occurrence of the following events through 5 years of follow-up: All-cause mortality and procedure/device-related mortality Venus P-ValveTM (catheter or surgical) reintervention Venus P-ValveTM dysfunction Serious procedure/device-related adverse events | through five years | 
| Functional status | New York Heart Association (NYHA) classification out to 5 years | through five years | 
| Health-state utility score | Health-state utility score as measured by the EQ-5D at pre-implant, 30 days, 6 months, 1 year and annually thereafter through 5 years. | through five years |