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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall mortality | to determine Overall mortality within 30 days after TAVI | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| TAVI-related in-Hospital and 30 d mortality | see title | 30 days after TAVI |
| complication rates | Complication rates as to VARC2 | 30 days after TAVI |
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Inclusion Criteria:
Exclusion Criteria:
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All Patients undergoing transaortic transcatheter valve implantation with commercially available Edwards SAPIEN XT Transcatheter Heart Valve with the Ascendra+ Delivery-System in participating sites
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| Name | Affiliation | Role |
|---|---|---|
| Vinayak Bapat, MD | St. Thomas' Hospital, London, UK | Principal Investigator |
| Mauro Romano, MD | Institut Hospitalier Jacques Cartier, Massy, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiac Surgery dpt., Innsbruck Medical University Hospital | Innsbruck | Austria | ||||
| Division of Cardiology, Helsinki University Central Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30346515 | Derived | 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. | |
| 28582580 |
| Label | URL |
|---|---|
| Design paper | View source |
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| Number of Patients with adverse Events in Relation to Baseline Parameters | Identify multivariable adjusted predictors for adverse outcomes of transaortic TAVI | 30 days after TAVI |
| Helsinki |
| Finland |
| CH J. Minjoz - Besancon | Besançon | 25030 | France |
| CHU Bordeaux | Bordeaux | 33604 | France |
| Hopital Cardio-Vasculaire et Pneumologie Louis Pradel | Lyon | France |
| Institut Jacques Cartier Massy | Massy | 91349 | France |
| CHU Rouen | Rouen | 76031 | France |
| CHU Rangueil - Toulouse | Toulouse | 31059 | France |
| Robert-Bosch-Hospital Stuttgart | Stuttgart | Baden-Wurttemberg | 70376 | Germany |
| Städt. Klinikum München GmbH Herzchirurgie Bogenhausen | München | Bavaria | 81925 | Germany |
| Westdeutsches Herzzentrum Essen - Uniklinikum - | Essen | North Rhine-Westphalia | 45122 | Germany |
| Universitätsklinikum Kiel - Kardiologie u. Angiologie | Kiel | Schleswig-Holstein | 24105 | Germany |
| Univ. Padova, Azienda Ospedaliera di Padova | Padova | 35128 | 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 |
| Derived |
| 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. |
| 28369303 | Derived | 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. |
| 27609256 | Derived | 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. |
| 25361564 | Derived | 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. |
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
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