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

N/ACompletedNCT01991431

Institut für Pharmakologie und Präventive Medizin303 enrolled

Overview

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.

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

Enrollment

303

Conditions

Aortic Stenosis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (19)

Cardiac Surgery dpt., Innsbruck Medical University Hospital

Innsbruck, Austria

Division of Cardiology, Helsinki University Central Hospital

Helsinki, Finland

Outcomes

Primary Outcomes

Overall mortality

to determine Overall mortality within 30 days after TAVI

Time frame: 30 days

Secondary Outcomes

TAVI-related in-Hospital and 30 d mortality

see title

Time frame: 30 days after TAVI

complication rates

Complication rates as to VARC2

Time frame: 30 days after TAVI

Number of Patients with adverse Events in Relation to Baseline Parameters

Identify multivariable adjusted predictors for adverse outcomes of transaortic TAVI

Time frame: 30 days after TAVI

Data from ClinicalTrials.gov

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