NCT01493284

Portico TAVI Implant With Transfemoral Delivery System

Assessment Of The St. Jude Medical Portico™ Transcatheter Aortic Valve Implant (TAVI) And The SJM TAVI Transfemoral Delivery System (Portico TF EU)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 222 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety and effectiveness of the SJM Portico Transcatheter Heart Valve and the SJM TAVI Transfemoral Transcatheter delivery system in subjects with severe symptomatic aortic stenosis (AS).

Detailed description

Data will be collected at baseline, procedure, discharge, 30 days post implant, 3 months post implant, 6 months post implant, and 12 months post implant.

Conditions

• Symptomatic Aortic Stenosis

Interventions

Type	Name	Description
DEVICE	Transcatheter Aortic Valve Implantation	Placement of the SJM Portico aortic valve with a transfemoral delivery system

Timeline

• Start date: 2011-12-01
• Primary completion: 2015-10-01
• Completion: 2016-09-01
• First posted: 2011-12-15
• Last updated: 2019-02-04
• Results posted: 2018-04-23

Locations

14 sites across 5 countries: Australia, Denmark, Germany, Netherlands, United Kingdom