NCT00820599

PREVAIL-TF: Transfemoral Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Europe)

Transfemoral Placement of AoRtic Balloon Expandable Transcatheter VAlves TrIaL (EUROPE)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 214 (actual)
• Sponsor: Edwards Lifesciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A single arm, prospective multicenter non-randomized confirmatory clinical trial evaluating the Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX; "study valve"), its transfemoral delivery system, and crimper accessories. The trial includes a premarket confirmatory cohort to evaluate the system performance as well as a Post Market Clinical Follow-up phase involving expanded enrollment and long-term follow-up of all patients to evaluate valve performance out to 5 years.

Detailed description

Edwards Lifesciences obtained CE marking authorization for transfemoral delivery / implantation of the Edwards SAPIEN™ transcatheter heart valve (model 9000TFX) using the RetroFlex™ delivery system in August 2007 and introduced these devices for commercial distribution in the European Economic Area (EEA) in October 2007. Clinical Sites: Up to 11 sites in Europe

Conditions

• Aortic Valve Stenosis

Interventions

Type	Name	Description
DEVICE	Sapien XT™ transcatheter heart valve and delivery system

Timeline

• Start date: 2008-12-01
• Primary completion: 2010-12-01
• Completion: 2016-03-01
• First posted: 2009-01-12
• Last updated: 2020-11-02
• Results posted: 2020-11-02

Locations

11 sites across 4 countries: Belgium, France, Germany, United Kingdom