NCT02000115

Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,242 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

The objective of the PORTICO pivotal IDE trial is to evaluate the safety and effectiveness of the St Jude Medical (SJM) Portico Transcatheter Heart Valve and Delivery Systems (Portico) in the treatment of severe symptomatic aortic stenosis via transfemoral and alternative delivery methods in high risk and extreme risk patients.

Detailed description

The PORTICO pivotal IDE trial will include a randomized cohort of 750 subjects enrolled at up to 70 investigational sites in the United States and Australia. Patients will be randomized (1:1) to receive the SJM Portico Transcatheter Heart Valve and Delivery Systems (Portico) or any FDA-approved, commercially-available Transcatheter Aortic Valve Replacement (TAVR) System. The randomized cohort will be tested for two co-primary endpoints at 30 days (primary safety endpoint) and 1 year (primary effectiveness endpoint). At the time of the primary randomized cohort analysis, the risk cohorts will be combined and analysis will be conducted on the intention-to-treat (n=750) population. The FlexNav Delivery System study will be conducted as a separate arm of the PORTICO IDE trial and will include up to 200 high or extreme risk subjects; including a minimum of 100 analysis subjects. The study will characterize the safety of the next-generation Portico Delivery System ("FlexNav™ Delivery System"). The primary analysis cohort will include FlexNav analysis subjects. The IDE Valve-in-Valve registry will enroll up to 100 high or extreme risk subjects with a failed surgical bioprosthesis who are eligible to receive a Portico Transcatheter Heart Valve. All subjects enrolled in the PORTICO pivotal IDE trial will undergo follow-up at baseline, peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, 12-months and then annually through 5-years.

Conditions

• Aortic Valve Stenosis

Interventions

Type	Name	Description
DEVICE	Portico transcatheter aortic valve	St. Jude Medical transcatheter Portico aortic valve
DEVICE	Commercially available transcatheter aortic valve	Commercially available transcatheter aortic valve

Timeline

• Start date: 2014-05-01
• Primary completion: 2019-10-01
• Completion: 2026-12-01
• First posted: 2013-12-03
• Last updated: 2025-07-20
• Results posted: 2021-01-12

Locations

70 sites across 2 countries: United States, Australia