SOURCE XT REGISTRY

Study Overview
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Brief Summary
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This registry is to expand upon existing data sets, to identify patient characteristics and indicators related to complications and clinical benefits for patients with symptomatic severe calcific degenerative aortic stenosis that are undergoing treatment with the commercially available Edwards SAPIEN XT™ Valve, and delivery devices.

Detailed Description
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Consecutive patient data should be collected at discharge, 30 days and 12 months post-implant. Subsets of patients may undergo additional follow-up.

Official Title
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Edwards SAPIEN™ Aortic Bioprosthesis Multi-Region Outcome Registry XT

Conditions
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Severe Aortic Stenosis

Intervention / Treatment
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* Device: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis
* Device: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis
* Device: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The SAPIEN XT™ THV is indicated for use in patients with symptomatic aortic stenosis requiring TAVI who have a high risk for operative mortality, or are non-operable Exclusion Criteria: Non-valvular or congenital aortic stenosis Pre-existing prosthetic heart valve in the Aortic position or a non-calcified aortic valve Severe (>3+) mitral insufficiency or aortic regurgitation > 3+ Active bacterial endocarditis or other active infections Severe ventricular dysfunction with ejection fraction < 20% Coronary artery disease-related unstable angina Inability to tolerate anticoagulation / antiplatelet therapy
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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Registry 1 - SOURCE XT<br>Registry 1: All patients implanted with a SAPIEN XT valve, via Transfemoral access using NovaFlex (for 23mm and 26mm valve), or via Transapical access using Ascendra2 (23mm, 26mm and 29mm valve) | Device: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis<br>* Patients eligible for either transfemoral or transapical access and any of the 3 valve sizes (23, 26 or 29)<br>* Other names: TAVI Transcatheter Aortic Valve Implantation;|
| Registry 2 - Ascendra+<br>Registry 2: All patients implanted with a SAPIEN XT Valve, via Transapical or Transaortic access using Ascendra+ delivery system (23mm, 26mm and 29mm valve) | Device: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis<br>* Patients eligible for transapical or transaortic access and any of the 3 valve sizes (23mm, 26mm or 29mm)<br>* Other names: TAVI Transcatheter Aortic Valve Implantation;|
| Registry 3 - NovaFlex+ 29 mm<br>Registry 3: All patients implanted with a SAPIEN XT valve, 29mm only, via Transfemoral access using NovaFlex+ | Device: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis<br>* Patients eligible for transfemoral access and requiring a 29mm valve.<br>* Other names: TAVI Transcatheter Aortic Valve Implantation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess and track causality and sequelae of major adverse events |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness: observe trends in patient characteristics and outcomes over time |  | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SAPIEN XT™, Transfemoral, NovaFlex, NovaFlex+, NF, NF+, Transapical, Transaortic, Ascendra2, Ascendra+, Asc+, aortic stenosis, aortic valve, Transcatheter Heart Valve, THV