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).
|type of project||clinical studies|
|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|