THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial — PARTNER  

Critical Aortic Stenosis Clinical Trial

Official title: THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial Edwards SAPIEN Transcatheter Heart Valve

Status Active, not recruiting

Clinical Trial Summary

The purpose of this study is to determine the safety and effectiveness of the device and delivery systems (transfemoral and transapical) in high risk, symptomatic patients with severe aortic stenosis.

Clinical Trial Description

Subjects will undergo a physical exam and screening tests will be performed to determine if they are either A) a patient with a high surgical risk or B) not a candidate for surgery. They will then be randomized (like the flip of a coin) to have the investigational device implanted or to receive the current surgical or medical management available. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Critical Aortic Stenosis

• NCT number: NCT00530894
• Study type: Interventional
• Source: Edwards Lifesciences
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 2007
• Completion date: March 2017