NCT01819181

Women's INternational Transcatheter Aortic Valve Implantation Registry

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,019 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study will evaluate all female patients with severe aortic stenosis undergoing transcatheter valve implantation with commercially available valves and delivery systems.

Detailed description

WINTAVI is an international, multi-centre, prospective, observational registry. The purpose of this study is to collect 'real-world' data regarding the clinical utility of all commercially available Transcatheter Aortic Valve Implantation (TAVI) devices for percutaneous aortic valve implantation in female patients with severe Aortic Stenosis (AS) requiring treatment. Data collected in this study will provide additional information on the understanding of the safety and device performance in a 'real-world' setting and how to best treat patients with severe AS. This will include Quality of Life questionnaires (KCCQ).

Conditions

• Symptomatic Aortic Stenosis

Timeline

• Start date: 2013-03-01
• Primary completion: 2016-05-01
• Completion: 2018-04-26
• First posted: 2013-03-27
• Last updated: 2018-05-04

Locations

10 sites across 6 countries: United States, France, Italy, Netherlands, Spain, United Kingdom