The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII B — PARTNERII B  

Calcific Aortic Stenosis Clinical Trial

Official title: The PARTNER II Trial "Placement of AoRTic TraNscathetER" Valves Trial" (US) [PII B] for Inoperable Patients

Status Completed

Clinical Trial Summary

The purpose of this study is to determine the safety and effectiveness of the SAPIEN XT™ THV with the associated delivery system for inoperable patients with severe symptomatic native aortic stenosis.

Clinical Trial Description

Cohort B was a 1:1 randomized, controlled study independently powered to compare transcatheter heart valve therapy with the first generation (SAPIEN™ THV) system to transcatheter heart valve therapy with the second generation (SAPIEN XT THV) system in patients who could not undergo surgery (inoperable).

Patients in the control arm of Cohort B received an Edwards SAPIEN THV with the associated delivery system while patients in the treatment arm of Cohort B received an Edwards SAPIEN XT THV with the associated delivery system. ;

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Calcific Aortic Stenosis
• Calcinosis
• Severe
• Symptomatic

• NCT number: NCT02184442
• Study type: Interventional
• Source: Edwards Lifesciences
• Status: Completed
• Phase: N/A
• Start date: March 9, 2011
• Completion date: May 30, 2017