NCT01238497

SOURCE XT REGISTRY

Edwards SAPIEN™ Aortic Bioprosthesis Multi-Region Outcome Registry XT

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,954 (actual)
• Sponsor: Edwards Lifesciences · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Severe Aortic Stenosis

Interventions

Type	Name	Description
DEVICE	TAVR 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)
DEVICE	TAVR Implantation of the Transcatheter Aortic Valve Prosthesis	Patients eligible for transapical or transaortic access and any of the 3 valve sizes (23mm, 26mm or 29mm)
DEVICE	TAVR Implantation of the Transcatheter Aortic Valve Prosthesis	Patients eligible for transfemoral access and requiring a 29mm valve.

Timeline

• Start date: 2010-09-01
• Primary completion: 2014-08-01
• Completion: 2016-11-01
• First posted: 2010-11-10
• Last updated: 2020-08-28

Locations

104 sites across 18 countries: Austria, Belgium, Canada, Czechia, Denmark, Finland, France, Germany, Greece, Israel, Italy, Netherlands, Norway, Poland, South Africa, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated device study