SOURCE XT REGISTRY

Edwards Lifesciences2,954 enrolled

Overview

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.

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

Study Type

OBSERVATIONAL

Enrollment

2,954

Conditions

Severe Aortic Stenosis

Interventions

TAVR Implantation of the Transcatheter Aortic Valve ProsthesisDEVICE

Patients eligible for either transfemoral or transapical access and any of the 3 valve sizes (23, 26 or 29)

TAVR Implantation of the Transcatheter Aortic Valve ProsthesisDEVICE

Patients eligible for transapical or transaortic access and any of the 3 valve sizes (23mm, 26mm or 29mm)

TAVR Implantation of the Transcatheter Aortic Valve ProsthesisDEVICE

Patients eligible for transfemoral access and requiring a 29mm valve.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (104)

Outcomes

Primary Outcomes

Assess and track causality and sequelae of major adverse events

Time frame: 30 days

Secondary Outcomes

Effectiveness: observe trends in patient characteristics and outcomes over time

Time frame: One year

Data from ClinicalTrials.gov

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Universitatsklinik Innsbruck

Innsbruck, Austria

Medical University Vienna

Vienna, Austria

Onze Lieve Vrouw Ziekenhuis

Aalst, Belgium

Clinique St Luc

Bouge, Belgium

Cliniques Universitaires Saint Luc

Brussels, Belgium

Universitaire Ziekenhuizen Leuven

Leuven, Belgium

Foothills Medical Centre

Calgary, Alberta, Canada

University of Alberta Hospital

Edmonton, Alberta, Canada

St. Paul's Hospital

Vancouver, British Columbia, Canada

St. John Regional Hospital

Saint John, New Brunswick, Canada

...and 94 more locations