CONFIDENCE Registry to Assess Safety and Performance of Portico System to Treat Patients With Severe Aortic Stenosis.

CONtrolled Delivery For ImproveD outcomEs With cliNiCal Evidence

The purpose of this clinical investigation is to characterize the procedural safety and device performance of transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in patients with symptomatic degenerative aortic stenosis.

The CONFIDENCE registry study will be conducting as a prospective, non-randomized, observational, single-arm, multi-center study.

Approximately 1000 subjects with severe symptomatic (NYHA class ≥ II) aortic stenosis (AS), will undergo Portico™ Transcatheter Aortic Heart Valve implantation.

The subject data will be collected at baseline, index procedure, pre- discharge, 30 days and 12 months from the index procedure.

Inclusion Criteria:

1. Subjects who are ≥18 years of age or legal age in host country and have been identified as a candidate for a Portico™ valve implant
2. Subjects who have been informed of the nature of the study, agree to its provisions and have provided written informed consent as approved by the Ethics Committee (EC) of the respective clinical center

Exclusion Criteria:

1. Have sepsis, including active endocarditis
2. Have any evidence of left ventricular or atrial thrombus
3. Have vascular conditions (i.e. caliber, stenosis, tortuosity, or severe calcification) that make insertion and endovascular access to the aortic valve improbable
4. Have a non-calcified aortic annulus
5. Have congenital bicuspid or unicuspid leaflet configuration
6. Are unable to tolerate antiplatelet/anticoagulant therapy
7. Are pregnant at the time of signing informed consent
8. Are currently participating in a drug or device study that may impact the registry (unless prior sponsor approval for co-enrollment is granted)