Clinical trial NCT01991431: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Stenosis
Lead sponsor: Institut für Pharmakologie und Präventive Medizin
Sponsor class: NETWORK
First posted: 2013-11-25
Enrollment: 303
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All Patients undergoing transaortic transcatheter valve implantation with commercially available Edwards SAPIEN XT Transcatheter Heart Valve with the Ascendra+ Delivery-System in participating sites

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.

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

Primary outcomes:
measure: Overall mortality
timeFrame: 30 days
Secondary outcomes:
measure: TAVI-related in-Hospital and 30 d mortality
timeFrame: 30 days after TAVI
measure: complication rates
timeFrame: 30 days after TAVI
measure: Number of Patients with adverse Events in Relation to Baseline Parameters
timeFrame: 30 days after TAVI
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Cardiac Surgery dpt., Innsbruck Medical University Hospital
city: Helsinki
country: Finland
facility: Division of Cardiology, Helsinki University Central Hospital
city: Besancon
country: France
facility: CH J. Minjoz - Besancon
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Lyon
country: France
facility: Hopital Cardio-Vasculaire et Pneumologie Louis Pradel
city: Massy
country: France
facility: Institut Jacques Cartier Massy
city: Rouen
country: France
facility: CHU Rouen
city: Toulouse
country: France
facility: CHU Rangueil - Toulouse
city: Stuttgart
country: Germany
facility: Robert-Bosch-Hospital Stuttgart
state: Baden-Württemberg
city: München
country: Germany
facility: Städt. Klinikum München GmbH Herzchirurgie Bogenhausen
state: Bayern
city: Essen
country: Germany
facility: Westdeutsches Herzzentrum Essen - Uniklinikum -
state: Nordrhein-Westfalen
city: Kiel
country: Germany
facility: Universitätsklinikum Kiel - Kardiologie u. Angiologie
state: Schleswig-Holstein
city: Padova
country: Italy
facility: Univ. Padova, Azienda Ospedaliera di Padova
city: Pavia
country: Italy
facility: Policlinico San Matteo/Department of Cardiac Surgery
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum
city: Oslo
country: Norway
facility: Rikshospital Oslo
city: Gdansk
country: Poland
facility: Klinika Kardiochirurgii UCK Gdansk
city: London
country: United Kingdom
facility: St. Thomas Hospital Cardiothoracic surgery dept
city: Middlesborough
country: United Kingdom
facility: James Cook Hospital - Cardiothoracic Division
Study officials:
affiliation: St. Thomas' Hospital, London, UK
name: Vinayak Bapat, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut Hospitalier Jacques Cartier, Massy, France
name: Mauro Romano, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cocchieri R, Petzina R, Romano M, 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, Bapat V, Baumbach H, Sims H, Deutsch C, Bramlage P, Kurucova J, Thoenes M, Frank D. Outcomes after transaortic transcatheter aortic valve implantation: long-term findings from the European ROUTEdagger. Eur J Cardiothorac Surg. 2019 Apr 1;55(4):737-743. doi: 10.1093/ejcts/ezy333.
citation: Romano M, Frank D, Cocchieri R, Jagielak D, Bonaros N, Aiello M, Lapeze J, Laine M, Chocron S, Muir D, Eichinger W, Thielmann M, Labrousse L, Arne Rein K, Verhoye JP, Gerosa G, Baumbach H, Deutsch C, Bramlage P, Thoenes M, Bapat V. Transaortic transcatheter aortic valve implantation using SAPIEN XT or SAPIEN 3 valves in the ROUTE registry. Interact Cardiovasc Thorac Surg. 2017 Nov 1;25(5):757-764. doi: 10.1093/icvts/ivx159.
citation: Bonaros N, Petzina R, Cocchieri R, Jagielak D, Aiello M, Lapeze J, Laine M, Chocron S, Muir D, Eichinger W, Thielmann M, Labrousse L, Bapat V, Arne Rein K, Verhoye JP, Gerosa G, Baumbach H, Kofler M, Bramlage P, Deutsch C, Thoenes M, Frank D, Romano M. Transaortic transcatheter aortic valve implantation as a first-line choice or as a last resort? An analysis based on the ROUTE registry. Eur J Cardiothorac Surg. 2017 May 1;51(5):919-926. doi: 10.1093/ejcts/ezw406.
citation: 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. Transcatheter Aortic Valve Replacement Using Transaortic Access: Experience From the Multicenter, Multinational, Prospective ROUTE Registry. JACC Cardiovasc Interv. 2016 Sep 12;9(17):1815-22. doi: 10.1016/j.jcin.2016.06.031.
citation: Bramlage P, Romano M, Bonaros N, Cocchieri R, Jagielak D, Frank D, Bapat V. Transaortic transcatheter aortic valve implantation - rationale and design of the multicenter, multinational prospective ROUTE registry. BMC Cardiovasc Disord. 2014 Nov 1;14:152. doi: 10.1186/1471-2261-14-152.