PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - S3 Intermediate — PII S3i  

Symptomatic Severe Aortic Stenosis Clinical Trial

Official title: Edwards SAPIEN 3 Transcatheter Heart Valve Therapy for Intermediate Risk Patients

Status Active, not recruiting

Clinical Trial Summary

The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN 3 transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, and severe aortic stenosis, and those with intermediate risk.

Clinical Trial Description

This study design consists of PIIS3i cohort. The PIIS3i cohort is a single arm non-randomized, historical-controlled study. Patients recruited to the treatment arm will receive an Edwards SAPIEN 3 THV with either transfemoral, transapical or transaortic delivery access. To ensure that patients are of "intermediate" risk, an STS score of 4 - 8% has been selected. ;

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Symptomatic Severe Aortic Stenosis

• NCT number: NCT03222128
• Study type: Interventional
• Source: Edwards Lifesciences
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 17, 2014
• Completion date: November 2025