Portico Next Generation Approval Study

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.

NCT Number	NCT04011722
Lead Sponsor	Abbott Medical Devices
Conditions	Symptomatic Severe Aortic Stenosis
Enrollment	333 participants
Start Date	2019-09-17
Primary Completion	2023-01-12 (estimated)
Study Completion	2033-01 (estimated)
Updated on ClinicalTrials.gov	2026-07-21