Portico and Navitor India Clinical Trial

Prior treatment

• Are unable to tolerate antiplatelet/anticoagulant therapy
• Are currently participating in a drug or device study that may impact this study (unless prior sponsor approval for co-enrollment is granted)

Other illness

• Have tested positive for the Corona Virus Disease 2019 (COVID-19) virus at any time AND currently have residual signs or symptoms associated with the COVID-19 virus (eg. evidence of thrombosis, damaged/inflamed heart muscle, damaged/inflamed lung tissue, etc.)
• Have vascular conditions (i.e. caliber, stenosis, tortuosity, or severe calcification) that make insertion and endovascular access to the aortic valve improbable

Other

• Have sepsis, including active endocarditis
• Have any evidence of left ventricular or atrial thrombus
• Have a non-calcified aortic annulus
• Have congenital bicuspid or unicuspid leaflet configuration
• Are pregnant at the time of signing informed consent

• Subject must provide written informed consent prior to any clinical investigation-related procedure.
• Are \>60 years of age in host country, have severe symptomatic (NYHA class ≥ II) aortic stenosis (AS), at high or extreme surgical risk and have been identified as a candidate for a Portico or Navitor valve implant.
• Subjects must have a Society of Thoracic Surgeons (STS) score of ≥7% OR documented heart team agreement of high or extreme risk for surgical aortic valve replacement due to frailty or co-morbidities not captured by the STS score.