SOURCE XT REGISTRY

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.

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Key information

Conditions

Severe Aortic Stenosis Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitatsklinik Innsbruck, Innsbruck, Austria

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TAVR Implantation of the Transcatheter Aortic Valve Prosthesis

Device

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

Other names: TAVI Transcatheter Aortic Valve Implantation

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

Sponsors and collaborators

Lead sponsor

Edwards Lifesciences

Industry

Registry information

Official study title

Edwards SAPIEN™ Aortic Bioprosthesis Multi-Region Outcome Registry XT

Important dates

Study start: 2010
Primary completion: 2014
Study completion: 2016
First posted: Nov 10, 2010
Registry last updated: Aug 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed