SOURCE XT REGISTRY

Edwards SAPIEN™ Aortic Bioprosthesis Multi-Region Outcome Registry XT

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01238497

Enrollment

2954

Registered

2010-11-10

Start date

2010-09-30

Completion date

2016-11-30

Last updated

2020-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Aortic Stenosis

Keywords

SAPIEN XT™, Transfemoral, NovaFlex, NovaFlex+, NF, NF+, Transapical, Transaortic, Ascendra2, Ascendra+, Asc+, aortic stenosis, aortic valve, Transcatheter Heart Valve, THV

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.

Interventions

DEVICETAVR Implantation of the Transcatheter Aortic Valve Prosthesis

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

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Assess and track causality and sequelae of major adverse events	30 days

Secondary

Measure	Time frame
Effectiveness: observe trends in patient characteristics and outcomes over time	One year

Countries

Austria, Belgium, Canada, Czechia, Denmark, Finland, France, Germany, Greece, Israel, Italy, Netherlands, Norway, Poland, South Africa, Spain, Switzerland, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026