Portico NG - Evaluation of the Navitor Transcatheter Aortic Valve in High and Extreme Risk Patients with Symptomatic Severe Aortic Stenosis

The primary objective of this clinical study is to evaluate the acute safety and effectiveness of the Navitor Transcatheter Aortic Heart Valve as assessed by the rate of all-cause mortality at 30 days and the rate of moderate or greater paravalvular leak at 30 days. The results from this study will be descriptively compared to the data from the first-generation Portico Transcatheter Aortic Heart Valve and commercially available TAVI devices studied in the same patient population (e.g. high and extreme surgical risk).

Trial phase

Other

Trial participation type

This trial has been designed for the Clinical Research of a Device.

Principal investigator

Prof Antony Walton

Key inclusion data

Active, not recruiting