ROUTE Registry Of the Utilisation of the Transaortic (Tao) TAVI Approach Using the Edwards Sapien XT Valve

Institut für Pharmakologie und Präventive Medizin

Status: Completed

Conditions: Aortic Stenosis

Study type: Observational

Funder types: NETWORK

Identifiers

NCT01991431

U1111-1149-9900

Details and patient eligibility

About

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.

Full 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.

Enrollment: 303 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

303 participants in 1 patient group

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