Portico NG Approval Study
Last updated on July 2021Recruitment
- 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