PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High Risk — PII A  

Symptomatic Severe Aortic Stenosis Clinical Trial

Official title: Edwards SAPIEN XT Transcatheter Heart Valve Therapy for Intermediate and High Risk Patients

Status Completed

Clinical Trial Summary

The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN XT transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, severe aortic stenosis.

Clinical Trial Description

The PIIA cohort is a prospective multi-center trial undergoing aortic valve replacement for severe aortic stenosis. Patients randomized to the treatment arm will receive an Edwards SAPIEN XT THV with either transfemoral, transapical or transaortic delivery access. Patients in the control arm will receive a surgical bioprosthetic heart valve via aortic valve replacement surgery.

To assure that patients with an STS score ≥ 4% have been selected. ;

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Symptomatic Severe Aortic Stenosis

• NCT number: NCT01314313
• Study type: Interventional
• Source: Edwards Lifesciences
• Status: Completed
• Phase: N/A
• Start date: March 2011
• Completion date: January 17, 2024