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

Conditions

Aortic Stenosis

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.

Riccardo Cocchieri, Rainer Petzina, Mauro Romano, Dariusz Jagielak, Nikolaos Bonaros et al. (24 authors)

European Journal of Cardio-Thoracic Surgery2018-09-1020 citations

10.1093/ejcts/ezy333

Transaortic transcatheter aortic valve implantation using SAPIEN XT or SAPIEN 3 valves in the ROUTE registry†

Mauro Romano, Derk Frank, Riccardo Cocchieri, Dariusz Jagielak, Nikolaos Bonaros et al. (21 authors)

Interactive Cardiovascular and Thoracic Surgery2017-04-257 citations

10.1093/icvts/ivx159

Transaortic transcatheter aortic valve implantation as a first-line choice or as a last resort? An analysis based on the ROUTE registry†

Nikolaos Bonaros, Rainer Petzina, Riccardo Cocchieri, Dariusz Jagielak, Marco Aiello et al. (23 authors)

European Journal of Cardio-Thoracic Surgery2016-12-1820 citations

10.1093/ejcts/ezw406

Transcatheter Aortic Valve Replacement Using Transaortic Access: Experience From the Multicenter, Multinational, Prospective ROUTE Registry.

Bapat V, Frank D, Cocchieri R, Jagielak D, Bonaros N, Aiello M, Lapeze J, Laine M, Chocron S, Muir D, Eichinger W, Thielmann M, Labrousse L, Rein KA, Verhoye JP, Gerosa G, Baumbach H, Bramlage P, Deutsch C, Thoenes M, Romano M.

2016-09-0133 citations

10.1016/j.jcin.2016.06.031

Transaortic transcatheter aortic valve implantation - rationale and design of the multicenter, multinational prospective ROUTE registry.

Bramlage P, Romano M, Bonaros N, Cocchieri R, Jagielak D, Frank D, Bapat V.

2014-11-018 citations

10.1186/1471-2261-14-152

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame	Description
Overall mortality	30 days	to determine Overall mortality within 30 days after TAVI

Secondary

Measure	Time frame	Description
TAVI-related in-Hospital and 30 d mortality	30 days after TAVI	see title
complication rates	30 days after TAVI	Complication rates as to VARC2
Number of Patients with adverse Events in Relation to Baseline Parameters	30 days after TAVI	Identify multivariable adjusted predictors for adverse outcomes of transaortic TAVI

Countries

Austria, Finland, France, Germany, Italy, Netherlands, Norway, Poland, United Kingdom

Outcome results