Status:
COMPLETED
SOURCE XT REGISTRY
Lead Sponsor:
Edwards Lifesciences
Conditions:
Severe Aortic Stenosis
Eligibility:
All Genders
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 dege...
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
2954 Patients enrolled
Trial Details
Trial ID
NCT01238497
Start Date
September 1 2010
End Date
November 1 2016
Last Update
August 28 2020
Active Locations (104)
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1
Universitatsklinik Innsbruck
Innsbruck, Austria, 6020
2
Medical University Vienna
Vienna, Austria, 1090
3
Onze Lieve Vrouw Ziekenhuis
Aalst, Belgium, 9300
4
Clinique St Luc
Bouge, Belgium, 5004