Evaluation of the GORE PV1 Device in Patients With Pulmonary Valve Dysfunction

Study Overview
=================
Brief Summary
-----------------
This study will assess the safety and performance of the GORE PV1 Device for replacement of the pulmonary valve and reconstruction of the Right Ventricular Outflow Tract (RVOT).

Official Title
-----------------
Evaluation of the GORE PV1 Device for Replacement of the Pulmonary Valve and Reconstruction of Right Ventricular Outflow Tract

Conditions
-----------------
Heart Defects, Congenital, Tetralogy of Fallot, Pulmonary Valve Insufficiency, Pulmonary Valve Stenosis

Intervention / Treatment
-----------------
* Device: GORE PV1


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A symptomatic or appropriate asymptomatic subject with a native or repaired right ventricular outflow tract requiring reconstruction with a valved conduit Age ≥5 years at the time of informed consent signature. Note: Additional Inclusion Criteria may apply Exclusion Criteria: An artificial valve at another position or will need an artificial valve at another position (i.e. replacement at the time of index procedure or anticipated within 3 years). Subjects with previously implanted pacemaker (including defibrillators). Major or progressive non-cardiac disease (liver failure, renal failure, cancer) that has a life expectancy of less than one year. Note: Additional Exclusion Criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 5 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br>Participants will receive the device on Day 1. | Device: GORE PV1<br>* Implantation of GORE PV1 Device for procedure to replace the pulmonary valve and reconstruct the right ventricular outflow tract (RVOT).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Valve-related mortality and device-related re-intervention | The composite of valve-related mortality and device-related re-intervention measured at 6 months post-procedure | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI change in right ventricular end diastolic volume index | Six month change from baseline in right ventricular end diastolic volume index as measured from Magnetic Resonance Imaging | 6 months | 
| MRI change in right ventricular end systolic volume index at 6 months | Six month change from baseline in right ventricular end systolic volume index as measured from Magnetic Resonance Imaging | 6 months | 
| MRI change in left ventricular diastolic volume index at 6 months | Six month change from baseline in left ventricular diastolic volume index as measured from Magnetic Resonance Imaging | 6 months | 
| MRI change in right ventricular ejection fraction at 6 months | Six month change from baseline in right ventricular ejection fraction index as measured from Magnetic Resonance Imaging | 6 months | 
| Echo change in right ventricular diastolic area at 12 months | Twelve month change from baseline in right ventricular diastolic area as measured from echocardiography | 12 months | 
| Echo change in right ventricular systolic area at 12 months | Twelve month change from baseline in right ventricular systolic area as measured from echocardiography | 12 months | 
| Echo change in left ventricular end diastolic volume index at 12 months | Twelve month change from baseline in left ventricular end diastolic volume index as measured from echocardiography | 12 months | 
| Echo change in right ventricular fractional area change at 12 months | Twelve month change from baseline in right ventricular fractional area change as measured from echocardiography | 12 months | 
| Six month mean pressure gradient <= 40 mmHG | Number of subjects with mean pressure gradient across conduit (RV to PA) less than or equal to 40 mmHg at 6 months | 6 months | 
| Twelve month mean pressure gradient <= 40 mmHG | Number of subjects with mean pressure gradient across conduit (RV to PA) less than or equal to 40 mmHg at 12 months | 12 months | 
| Six month pulmonary regurgitation < moderate | Number of subjects with pulmonary regurgitation less than moderate at 6 months | 6 months | 
| Twelve month pulmonary regurgitation < moderate | Number of subjects with pulmonary regurgitation less than moderate at 12 months | 12 months | 
| Device-related re-intervention at 1, 3, 6, 12, 24, 36, 48, and 60 months | Kaplan-Meier estimates of device-related re-intervention summarized at 1, 3, 6, 12 months, and annually through 5 years | 1, 3, 6, 12, 24, 36, 48, and 60 months | 
| All-cause mortality at 1, 3, 6, 12, 24, 36, 48, and 60 months | Kaplan-Meier estimates of all-cause mortality summarized at 1, 3, 6, 12 months, and annually through 5 years | 1, 3, 6, 12, 24, 36, 48, and 60 months |