SOURCE XT REGISTRY

Edwards Lifesciences

Status: Completed

Conditions: Severe Aortic Stenosis

Treatments: Device: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis

Study type: Observational

Funder types: Industry

Identifiers

NCT01238497

2010-10

Details and patient eligibility

About

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.

Full description

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

Enrollment: 2,954 patients

Sex: All

Volunteers: No 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

Trial design

2,954 participants in 3 patient 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)

Treatment:

Device: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis

Device: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis

Device: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis

Registry 2 - Ascendra+

Description:

Registry 2: All patients implanted with a SAPIEN XT Valve, via Transapical or Transaortic access using Ascendra+ delivery system (23mm, 26mm and 29mm valve)

Treatment:

Device: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis

Device: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis

Device: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis

Registry 3 - NovaFlex+ 29 mm

Description:

Registry 3: All patients implanted with a SAPIEN XT valve, 29mm only, via Transfemoral access using NovaFlex+

Treatment:

Device: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis

Device: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis

Device: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis