symptomatic, severe native aortic stenosis
The Portico NG Approval study will be conducted as a prospective, multi-center, international, single-arm investigational study. High or extreme risk patients with symptomatic, severe native aortic stenosis who are determined by an independent subject selection committee to meet eligibility criteria for Portico NG Transcatheter Aortic Heart Valve implantation will undergo Portico™ NG Valve implantation via a transfemoral or alternative access approach according to the site's anesthesia protocol for TAVR (transcatheter aortic valve replacement) procedure.
- 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.
- Subject has symptomatic aortic stenosis as demonstrated by NYHA (New York Heart Association) Functional Classification of II, III, or IV.
- Subject has senile degenerative aortic valve stenosis with echo-derived criteria, defined as: aortic valve area (AVA) of ≤ 1.0 cm2 (or indexed EOA (effective orifice area) ≤ 0.6 cm2/m2) AND mean gradient ≥40 mmHg or peak jet velocity ≥ 4.0 m/s or doppler velocity index (DVI) ≤0.25. (Qualifying AVA baseline measurement must be within 90 days prior to informed consent).
- Aortic annulus diameter of 19-27mm and ascending aorta diameter of 26-42 mm for the specified valve size listed in the IFU (Instructions For Use), as measured by CT (Computed Tomography) conducted within 12 months prior to informed consent. (If a CT is contraindicated and/or not possible to be obtained for certain subjects, a 3D echocardiogram and non-contrast CT of chest and abdomen/pelvis may be accepted).