NCT01802788

5 Year Observation of Patients With PORTICO Valves

International Long-term Follow-up Study of Patients Implanted With a Portico™ Valve

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,032 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical investigation is to further assess the performance and safety profile of the commercially-available Portico™ TAVI System in patients with severe symptomatic aortic stenosis.

Detailed description

This is an international multicenter, prospective, non-randomized clinical investigation without concurrent or matched control, designed to assess the mid-term safety and performance of the Portico valve in patients with severe symptomatic aortic stenosis whom are high risk for surgical valve replacement. The primary endpoint is 1 year all-cause mortality. In addition, the performance and safety profile of the Portico valve will be further evaluated at 30 days, 1 year, and annually through 5 years post-implant. The investigation will be conducted at approximately 65 centers in approximately 15 countries in Europe, Middle-East, Africa, Canada, Australia and New Zealand.

Conditions

• Aortic Valve Stenosis

Interventions

Type	Name	Description
DEVICE	St Jude Medical Portico replacement aortic valve
PROCEDURE	Transcatheter Aortic Valve Implant

Timeline

• Start date: 2013-04-16
• Primary completion: 2018-09-25
• Completion: 2022-10-19
• First posted: 2013-03-01
• Last updated: 2025-02-11
• Results posted: 2022-01-24

Locations

60 sites across 13 countries: Australia, Belgium, Canada, Denmark, France, Germany, Israel, Italy, Lithuania, Netherlands, Spain, Switzerland, United Kingdom