Brief Title
ROUTE Registry Of the Utilisation of the Transaortic (Tao) TAVI Approach Using the Edwards Sapien XT Valve
Official Title
Registry Of the Utilisation of the Transaortic (Tao) TAVI Approach Using the Edwards Sapien XT Valve
Brief Summary
This is an international multi-center, prospective, observational registry with consecutive patient enrollment intended to determine outcome Parameters within 30 days after transaortic transcatheter aortic valve replacement.
Detailed Description
The purpose of this registry is to expand upon existing data sets, to identify patient characteristics and indicators related to complications and clinical benefits for patients with symptomatic severe calcific degenerative aortic stenosis that are undergoing transaortic transcatheter procedure with the commercially available Edwards SAPIEN XT Transcatheter Heart Valve with the Ascendra+ System.
Study Type
Observational [Patient Registry]
Primary Outcome
Overall mortality
Secondary Outcome
TAVI-related in-Hospital and 30 d mortality
Condition
Aortic Stenosis
Study Arms / Comparison Groups
TAVI
Description: All Patients undergoing transaortic transcatheter valve implantation with commercially available Edwards SAPIEN XT Transcatheter Heart Valve with the Ascendra+ Delivery-System in participating sites
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
303
Start Date
February 2013
Completion Date
November 2016
Primary Completion Date
November 2015
Eligibility Criteria
Inclusion Criteria: - Intended transaortic (Tao) TAVI using Edwards SAPIEN XT Transcatheter Heart Valve with the Ascendra+ Delivery-System - Compliance with the indications according to the Instructions for Use - Written informed consent Exclusion Criteria: - Presence of contraindications as to the Instructions for Use - TAo with concomitant procedure (e.g. Tao + CABG) - Participation in the SOURCE XT registry
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Vinayak Bapat, MD, ,
Location Countries
Austria
Location Countries
Austria
Administrative Informations
NCT ID
NCT01991431
Organization ID
U1111-1149-9900
Responsible Party
Sponsor
Study Sponsor
Institut für Pharmakologie und Präventive Medizin
Study Sponsor
Vinayak Bapat, MD, Principal Investigator, St. Thomas' Hospital, London, UK
Verification Date
February 2017