ROUTE Registry Of the Utilisation of the Transaortic (Tao) TAVI Approach Using the Edwards Sapien XT Valve
NCT ID: NCT01991431
Last Updated: 2017-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
303 participants
OBSERVATIONAL
2013-02-28
2016-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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TAVI
All Patients undergoing transaortic transcatheter valve implantation with commercially available Edwards SAPIEN XT Transcatheter Heart Valve with the Ascendra+ Delivery-System in participating sites
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Compliance with the indications according to the Instructions for Use
* Written informed consent
Exclusion Criteria
* TAo with concomitant procedure (e.g. Tao + CABG)
* Participation in the SOURCE XT registry
18 Years
ALL
No
Sponsors
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Institut für Pharmakologie und Präventive Medizin
NETWORK
Responsible Party
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Principal Investigators
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Vinayak Bapat, MD
Role: PRINCIPAL_INVESTIGATOR
St. Thomas' Hospital, London, UK
Mauro Romano, MD
Role: PRINCIPAL_INVESTIGATOR
Institut Hospitalier Jacques Cartier, Massy, France
Locations
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Cardiac Surgery dpt., Innsbruck Medical University Hospital
Innsbruck, , Austria
Division of Cardiology, Helsinki University Central Hospital
Helsinki, , Finland
CH J. Minjoz - Besancon
Besançon, , France
CHU Bordeaux
Bordeaux, , France
Hopital Cardio-Vasculaire et Pneumologie Louis Pradel
Lyon, , France
Institut Jacques Cartier Massy
Massy, , France
CHU Rouen
Rouen, , France
CHU Rangueil - Toulouse
Toulouse, , France
Robert-Bosch-Hospital Stuttgart
Stuttgart, Baden-Wurttemberg, Germany
Städt. Klinikum München GmbH Herzchirurgie Bogenhausen
München, Bavaria, Germany
Westdeutsches Herzzentrum Essen - Uniklinikum -
Essen, North Rhine-Westphalia, Germany
Universitätsklinikum Kiel - Kardiologie u. Angiologie
Kiel, Schleswig-Holstein, Germany
Univ. Padova, Azienda Ospedaliera di Padova
Padua, , Italy
Policlinico San Matteo/Department of Cardiac Surgery
Pavia, , Italy
Academisch Medisch Centrum
Amsterdam, , Netherlands
Rikshospital Oslo
Oslo, , Norway
Klinika Kardiochirurgii UCK Gdansk
Gdansk, , Poland
St. Thomas Hospital Cardiothoracic surgery dept
London, , United Kingdom
James Cook Hospital - Cardiothoracic Division
Middlesbrough, , United Kingdom
Countries
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References
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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.
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.
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.
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.
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.
Related Links
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Other Identifiers
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U1111-1149-9900
Identifier Type: -
Identifier Source: org_study_id
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