FlexNav EU CE Mark Study

Symptomatic Severe Aortic Stenosis Clinical Trial

Official title: Assessment of the Abbott FlexNav™ Delivery System for Portico Transcatheter Aortic Valve Implantation in High and Extreme Risk Patients With Symptomatic Severe Aortic Stenosis

Status Completed

Clinical Trial Summary

The purpose of this clinical investigation is to characterize the safety of the next-generation FlexNav™ Delivery System for transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in symptomatic severe aortic stenosis patients who are considered of high or extreme risk for surgical aortic valve replacement. Data from the study will be used to support CE Mark of the FlexNav™ Delivery System and Loading System in Europe.

Clinical Trial Description

The FlexNav European Union (EU) study will be conducted as a prospective, multi-center, single-arm investigational study.

High or extreme risk patients with symptomatic, severe native aortic stenosis who are determined by an independent subject selection committee to meet eligibility criteria for Portico™ Transcatheter Aortic Heart Valve implantation via a transfemoral access approach will undergo a Portico valve implant using the next-generation FlexNav Delivery System.

Subject data will be collected at screening, baseline, pre-procedure, peri-procedure, post-procedure, discharge, 30 days, 6 months and 1-year from the index procedure. ;

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic
• Symptomatic Severe Aortic Stenosis

• NCT number: NCT03724812
• Study type: Interventional
• Source: Abbott Medical Devices
• Status: Completed
• Phase: N/A
• Start date: February 26, 2019
• Completion date: February 10, 2021