NCT03724812

FlexNav EU CE Mark Study

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 21 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Symptomatic Severe Aortic Stenosis

Interventions

Type	Name	Description
DEVICE	Portico Valve and FlexNav™ Delivery System	Subjects will undergo transcatheter aortic valve replacement (TAVR) with the Portico valve and second-generation FlexNav Delivery system via a transfemoral access approach

Timeline

• Start date: 2019-02-26
• Primary completion: 2020-01-14
• Completion: 2021-02-10
• First posted: 2018-10-30
• Last updated: 2021-11-24
• Results posted: 2021-03-16

Locations

6 sites across 4 countries: Denmark, Italy, Switzerland, United Kingdom