NCT01074658

CoreValve Advance International Post Market Study

CoreValve Advance International Post Market Study: Evaluation of the Medtronic CoreValve System in a "Real-World" Patient Population.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,015 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The CoreValve Advance study is intended to evaluate the clinical utility of the Medtronic CoreValve System in a "Real-World" patient population.

Detailed description

The CoreValve Advance study is intended to evaluate the clinical utility of the Medtronic CoreValve System for percutaneous aortic valve implantation in a "Real-World" patient population with severe aortic valve stenosis. Data collected in this study will provide additional information on the understanding of the safety and device performance and how to best treat elderly patients with severe aortic valve stenosis. In addition, health economic data will be collected to understand the improvement of quality of life and the cost effectiveness of the therapy.

Conditions

• Severe Aortic Stenosis

Interventions

Type	Name	Description
DEVICE	Medtronic CoreValve System	Transcatheter Aortic Valve Implantation of the Medtronic CoreValve System

Timeline

• Start date: 2010-03-01
• Primary completion: 2011-11-01
• Completion: 2017-05-01
• First posted: 2010-02-24
• Last updated: 2017-12-02
• Results posted: 2016-10-21

Locations

44 sites across 12 countries: Belgium, Colombia, Denmark, France, Germany, Greece, Israel, Italy, Netherlands, Portugal, Switzerland, United Kingdom