NCT01676727

ADVANCE Direct Aortic Study

CoreValve® ADVANCE Direct Aortic Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This study is intended to collect data regarding the clinical utility, safety and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI) in patients with severe symptomatic aortic valve stenosis for which treatment via direct aortic access (DA) is selected.

Detailed description

This study is intended to collect data regarding the clinical utility, safety and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI) in patients with severe symptomatic aortic valve stenosis for which treatment via direct aortic access (DA) is selected. As part of the study analysis, resource utilization together with the Quality of Life questionnaires data will provide an important input into cost effectiveness analysis.

Conditions

• Aortic Stenosis
• Valvular Heart Disease

Interventions

Type	Name	Description
DEVICE	CoreValve aortic valve	Implantation of CoreValve aortic valve via direct aortic approach

Timeline

• Start date: 2012-09-01
• Primary completion: 2014-04-01
• Completion: 2015-08-01
• First posted: 2012-08-31
• Last updated: 2018-09-19
• Results posted: 2018-07-30

Locations

9 sites across 6 countries: Czechia, France, Germany, Italy, Netherlands, United Kingdom