Portico ALT EU Version 01
Research type
Research Study
Full title
Assessment of the St. Jude Medical PorticoTM Re-sheathable Aortic Valve System – Alternative Access (Portico ALT EU)
IRAS ID
129948
Contact name
Uday Trivedi
Contact email
Sponsor organisation
St Jude Medical Cardiovascular Division, Inc.
Research summary
Currently for patients with severe aortic stenosis (narrowing of the main valve of the heart) who are unsuitable for conventional surgery or at high risk can have a new valve implanted using a minimamlly invasive heart valve implantion technique known as TAVI (transcather aortic valve implantation). The TAVI can be implanted via a catheter (thin tube to enter the artery) using the femoral (leg) artery or by a more invasive method called the transapical approach which involves a surgical incision in the chest wall to access the apex of the heart. These approaches aren’t suitable for all patients so two alternative methods to delivery the heart valve are being used. The subclavian/axillary approaches uses an artery near the collar bone and the transaortic (TAo) method involves an incision in the chest wall to access the aorta (the main artery arising from the heart) to allow direct placement of the TAVI.
The purpose of this clinical investigation is to evaluate the use of the Portico ALC
Delivery System to place a transcatheter aortic valve through an alternative access site, specifically subclavian/axillary or TAo. For the purpose of this clinical investigation, the CE marked Portico transfemoral (TF) delivery system is renamed the Portico alternative access clinical (ALC) delivery system. The ALC delivery system is identical to the CE marked commercially available TF delivery system and only differs in labeling content.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
13/EE/0173
Date of REC Opinion
4 Jul 2013
REC opinion
Further Information Favourable Opinion