The purpose of this clinical study is to evaluate the acute safety and effectiveness of the next-generation Navitor (Portico™ NG) 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 in a high or extreme surgical risk patient population to support CE (Conformité Européenne) Mark and FDA approval.
The Portico NG Approval study will be conducted as a prospective, multi-center, international, single-arm investigational study. Up to 399 (includes up to 20 roll-ins) 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 Navitor Transcatheter Aortic Heart Valve implantation will undergo Navitor Valve implantation via a transfemoral or alternative access approach according to the site's anesthesia protocol for TAVR (transcatheter aortic valve replacement) procedure. Subjects participating in the clinical study will be followed for a total of 12 months with data collected at screening, baseline, procedure, prior to hospital discharge, and follow-up at 30 days, 12 months and annually at 2, 3, 4 and 5 years. This study will also include a product size extension, Navitor Titan™ valve, which includes up to 90 subjects (Titan cohort) who will undergo an implant attempt with the Navitor Titan valve. Subjects enrolled in the Titan cohort will undergo the same screening, baseline, procedure and follow-up assessments as the Portico NG cohort.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
333
Subjects will undergo transcatheter aortic valve implantation (TAVI) with the new generation Portico NG (Navitor) valve and second-generation FlexNav Delivery system via a transfemoral or alternative access approach according to the site's anesthesia protocol for TAVR procedures.
Subjects will undergo transcatheter aortic valve implantation (TAVI) with the Navitor Titan valve and large FlexNav Delivery system via a transfemoral or alternative access approach according to the site's anesthesia protocol for TAVR procedures.
Primary Safety Endpoint is All-cause Mortality
All-cause mortality is defined as the total number of deaths in each cohort at 30 days.
Time frame: at 30 days
Primary Effectiveness Endpoint is Moderate or Greater Paravalvular Leak
Number of participants with moderate or greater paravalvular leak at 30 days.
Time frame: at 30 days
Non-hierarchical Composite of All-cause Mortality, Disabling Stroke, Life Threatening Bleeding, Acute Kidney Injury (Stage 3), or Major Vascular Complications
The secondary endpoint is defined as a non-hierarchical composite of all-cause mortality, disabling stroke, life threatening bleeding, acute kidney injury (stage 3), or major vascular complications at 30 days.
Time frame: at 30 days
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