Kantonsspital St.Gallen
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Flex Nav

Susanne Vetsch

abstract This CE Mark study is a prospective, multi-center, single-arm investigational study to support commercialization of the FlexNav™ Delivery System and Loading System in Europe.
The design of this clinical investigation is in compliance to ISO standards 14155:2011 and 5840-3:2013.
A maximum of 200 patients with symptomatic, severe AS considered by both a local Heart Team and independent Subject Selection Committee to be high or extreme risk for surgical aortic valve implantation will be enrolled from up to eight (8) experienced, high-volume TAVI implant centers in Europe. Experienced implant centers are defined as those sites that have completed the commercial Portico implant training program and have at least one primary implanting physician that has performed 50 or more Portico implants within the previous 12 months. No investigational site may enroll more than 20% of the maximum study sample (n=40).
   
project partner USZ
type of project clinical studies
status ongoing - recruiting phase
start of project 2019
end of project 2021
study design The purpose of this clinical investigation is to characterize the safety of the FlexNav™ Delivery System for transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve. Safety data collected as part of the study will be used to support CE Mark of the FlexNav™ Delivery System and Loading System in Europe
responsible person Dr. Philipp Haager, Susanne Vetsch