PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - High Risk and Nested Registry 7 — PII S3HR/NR7  

Symptomatic Severe Aortic Stenosis Clinical Trial

Official title: Edwards SAPIEN 3 Transcatheter Heart Valve Therapy for High Risk and Inoperable Patients

Status Completed

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, severe aortic stenosis, and are in high risk.

Clinical Trial Description

This is a prospective, non-randomized, multi-center trial for patients undergoing aortic valve replacement with the Edwards SAPIEN 3 THV for severe aortic stenosis. Patient cohorts will include those inoperable and those considered as a high surgical risk (STS ≥8%). The study also includes NR7 patients (patients with a 20mm vessel size). ;

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Symptomatic Severe Aortic Stenosis

• NCT number: NCT03222141
• Study type: Interventional
• Source: Edwards Lifesciences
• Status: Completed
• Phase: N/A
• Start date: October 2013
• Completion date: August 2020