Brief Title
SOURCE XT REGISTRY
Official Title
Edwards SAPIEN™ Aortic Bioprosthesis Multi-Region Outcome Registry XT
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 Type
Observational
Primary Outcome
Assess and track causality and sequelae of major adverse events
Secondary Outcome
Effectiveness: observe trends in patient characteristics and outcomes over time
Condition
Severe Aortic Stenosis
Intervention
TAVR Implantation of the Transcatheter Aortic Valve Prosthesis
Study Arms / Comparison Groups
Registry 1 - SOURCE XT
Description: 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)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
2954
Start Date
September 2010
Completion Date
November 2016
Primary Completion Date
August 2014
Eligibility Criteria
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
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Olaf Wendler, MD, PhD, FRCS, ,
Location Countries
Austria
Location Countries
Austria
Administrative Informations
NCT ID
NCT01238497
Organization ID
2010-10
Responsible Party
Sponsor
Study Sponsor
Edwards Lifesciences
Study Sponsor
Olaf Wendler, MD, PhD, FRCS, Principal Investigator, [email protected]
Verification Date
August 2020