SOURCE XT REGISTRY

Completed

• Conditions: Severe Aortic Stenosis

• Registration Number: NCT01238497
• Lead Sponsor: Edwards Lifesciences

Brief Summary

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

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

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-10-26
• Study First Submitted QC: 2010-11-09
• Study First Posted: 2010-11-10
• Primary Completion: 2014-08
• Study Completion: 2016-11
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-26
• Last Update Posted: 2020-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2954

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assess and track causality and sequelae of major adverse events	30 days

Secondary Outcome Measures

Name	Time	Method
Effectiveness: observe trends in patient characteristics and outcomes over time	One year

Trial Locations

Locations (103)

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

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