NCT01991431

ROUTE Registry Of the Utilisation of the Transaortic (Tao) TAVI Approach Using the Edwards Sapien XT Valve

Registry Of the Utilisation of the Transaortic (Tao) TAVI Approach Using the Edwards Sapien XT Valve

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 303 (actual)
• Sponsor: Institut für Pharmakologie und Präventive Medizin · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an international multi-center, prospective, observational registry with consecutive patient enrollment intended to determine outcome Parameters within 30 days after transaortic transcatheter aortic valve replacement.

Detailed description

The purpose of 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 transaortic transcatheter procedure with the commercially available Edwards SAPIEN XT Transcatheter Heart Valve with the Ascendra+ System.

Conditions

• Aortic Stenosis

Timeline

• Start date: 2013-02-01
• Primary completion: 2015-11-01
• Completion: 2016-11-01
• First posted: 2013-11-25
• Last updated: 2017-02-23

Locations

19 sites across 9 countries: Austria, Finland, France, Germany, Italy, Netherlands, Norway, Poland, United Kingdom