COMPASSION XT PAS - Post-approval Study of the SAPIEN XT THV in Patients With Pulmonary Valve Dysfunction

Study Overview
=================
Brief Summary
-----------------
This study will confirm the safety and effectiveness of the Edwards Lifesciences SAPIEN XT Transcatheter Heart Valve (THV) System in patients with a dysfunctional right ventricular outflow tract (RVOT) conduit with a clinical indication for intervention in a post-market setting.

Detailed Description
-----------------
The study is a prospective, non-randomized, multi-center clinical study to assess the safety and effectiveness of pulmonic implantation of the SAPIEN THV in patients with dysfunctional RVOT conduits requiring treatment for moderate or severe pulmonary regurgitation (PR) by transthoracic echocardiography (TTE) and/or RVOT conduit obstruction with a mean gradient of ≥ 35 mmHg by TTE.

Official Title
-----------------
New Enrollment SAPIEN XT Post-Approval Study

Conditions
-----------------
Pulmonary Valve Insufficiency, Pulmonary Valve Stenosis, Heart Defects, Congenital, Congenital Abnormalities, Cardiovascular Diseases, Heart Diseases

Intervention / Treatment
-----------------
* Device: SAPIEN XT THV


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has a dysfunctional, non-compliant RVOT conduit. The patient/patient's legally authorized representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent. Exclusion Criteria: Inability to tolerate an anticoagulation/antiplatelet regimen Active bacterial endocarditis
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TPVI<br>Transcatheter Pulmonary Valve Implantation with the SAPIEN XT THV | Device: SAPIEN XT THV<br>* SAPIEN XT THV will be implanted in the pulmonic position.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from device- or procedure-related death or reintervention |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in pulmonary regurgitation to mild or less for regurgitant lesions | Assessed via transthoracic echocardiogram (TTE) | 1 year | 
| Decrease in RVOT mean gradient to less than 30 mmHg for stenotic lesions | Assessed via TTE | 1 year | 
| Device Success | Device Success is a composite of: Deployment of the valve to the target area, and Removal of the delivery catheter out of the body, and Improvement in pulmonary regurgitation to mild or less per the earliest evaluable TTE. | 48 Hours Prior to Discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tetralogy of Fallot, Aortic Valve Defect/Disease Resulting in Ross Procedure, Transcatheter pulmonary valve implantation, Transcatheter pulmonary valve replacement, Pulmonary Atresia, Pulmonary Stenosis