Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
140

Summary

Conditions
Symptomatic Severe Aortic Stenosis
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Devices under investigation in this clinical study include the Portico™ NG Valve (23mm, 25mm, 27mm and 29mm sizes), FlexNav™ Delivery System(s) (small and large) and Portico™ NG Loading System(s) (small and large), all of which are currently approved for investigational use only.Masking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 100 years
Gender
Both males and females

Description

The Portico NG Approval study will be conducted as a prospective, multi-center, international, single-arm investigational study. Up to 189 (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...

The Portico NG Approval study will be conducted as a prospective, multi-center, international, single-arm investigational study. Up to 189 (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 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 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.

Tracking Information

NCT #
NCT04011722
Collaborators
Not Provided
Investigators
Not Provided