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. ;

Study Design

Related Conditions & MeSH terms

Aortic Valve Stenosis
Symptomatic Severe Aortic Stenosis

Clinical Trial Details

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

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT04011722` - Portico NG Approval Study	N/A
Completed	`NCT03222141` - PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - High Risk and Nested Registry 7	N/A
Completed	`NCT01314313` - PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High Risk	N/A
Recruiting	`NCT04788888` - Evaluation of TAVR Using the NAVITOR Valve in a Global Investigation	N/A
Completed	`NCT03724812` - FlexNav EU CE Mark Study	N/A