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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 treatment with the commercially available Edwards SAPIEN XT™ Valve, and delivery devices.
Consecutive patient data should be collected at discharge, 30 days and 12 months post-implant. Subsets of patients may undergo additional follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Registry 1 - SOURCE XT | Registry 1: All patients implanted with a SAPIEN XT valve, via Transfemoral access using NovaFlex (for 23mm and 26mm valve), or via Transapical access using Ascendra2 (23mm, 26mm and 29mm valve) |
| |
| Registry 2 - Ascendra+ | Registry 2: All patients implanted with a SAPIEN XT Valve, via Transapical or Transaortic access using Ascendra+ delivery system (23mm, 26mm and 29mm valve) |
| |
| Registry 3 - NovaFlex+ 29 mm | Registry 3: All patients implanted with a SAPIEN XT valve, 29mm only, via Transfemoral access using NovaFlex+ |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAVR Implantation of the Transcatheter Aortic Valve Prosthesis | Device | Patients eligible for either transfemoral or transapical access and any of the 3 valve sizes (23, 26 or 29) |
| Measure | Description | Time Frame |
|---|---|---|
| Assess and track causality and sequelae of major adverse events | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness: observe trends in patient characteristics and outcomes over time | One year |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with symptomatic aortic stenosis
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| Name | Affiliation | Role |
|---|---|---|
| Olaf Wendler, MD, PhD, FRCS | olaf.wendler@kch.nhs.uk | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitatsklinik Innsbruck | Innsbruck | 6020 | Austria | |||
| Medical University Vienna |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25946437 | Derived | Schymik G, Lefevre T, Bartorelli AL, Rubino P, Treede H, Walther T, Baumgartner H, Windecker S, Wendler O, Urban P, Mandinov L, Thomas M, Vahanian A. European experience with the second-generation Edwards SAPIEN XT transcatheter heart valve in patients with severe aortic stenosis: 1-year outcomes from the SOURCE XT Registry. JACC Cardiovasc Interv. 2015 Apr 27;8(5):657-69. doi: 10.1016/j.jcin.2014.10.026. |
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|
| TAVR Implantation of the Transcatheter Aortic Valve Prosthesis | Device | Patients eligible for transapical or transaortic access and any of the 3 valve sizes (23mm, 26mm or 29mm) |
|
|
| TAVR Implantation of the Transcatheter Aortic Valve Prosthesis | Device | Patients eligible for transfemoral access and requiring a 29mm valve. |
|
|
| Vienna |
| 1090 |
| Austria |
| Onze Lieve Vrouw Ziekenhuis | Aalst | 9300 | Belgium |
| Clinique St Luc | Bouge | 5004 | Belgium |
| Cliniques Universitaires Saint Luc | Brussels | 1200 | Belgium |
| Universitaire Ziekenhuizen Leuven | Leuven | 3000 | Belgium |
| Foothills Medical Centre | Calgary | Alberta | T2N 2T9 | Canada |
| University of Alberta Hospital | Edmonton | Alberta | T6G 2B7 | Canada |
| St. Paul's Hospital | Vancouver | British Columbia | V6Z 1Y6 | Canada |
| St. John Regional Hospital | Saint John | New Brunswick | E2L 4L2 | Canada |
| Hamilton Health Services | Hamilton | Ontario | L8L 2X2 | Canada |
| Southlake Hospital | Newmarket | Ontario | L3Y 2P9 | Canada |
| Toronto General Hospital | Toronto | Ontario | M5G 2C4 | Canada |
| Montreal Heart Institute | Montreal | Quebec | H1T 1CB | Canada |
| Centre Hospitalier De Universite of Montreal | Montreal | Quebec | H2W 1T8 | Canada |
| Hospital Laval | Sainte-Foy | Quebec | G1V 4G5 | Canada |
| University of Hradec Kralove | Hradec Králové | 5005 05 | Czechia |
| Aarhus University Hospital | Aarhus | 8200 | Denmark |
| Helsinki University Central Hospital | Helsinki | FIN-00029 HUS | Finland |
| Tampere University Hospital | Tampere | 33521 | Finland |
| CHU Jean Minjoz | Besançon | 25030 | France |
| CHU La Cavalle Blanche | Brest | 29609 | France |
| Hôpital Privé Parly II | Le Chesnay | 78150 | France |
| Centre Chirurgical Marie Lannelongue | Le Plessis-Robinson | 92350 | France |
| CHU La Timone | Marseille | 13005 | France |
| Hôpital St Joseph | Marseille | 13008 | France |
| Clinique Clairval | Marseille | 13009 | France |
| Institut Hospitalier Jacques Cartier | Massy | 91300 | France |
| CHU Montpellier - Hôpital Arnaud de Villeneuve | Montpellier | 34295 | France |
| Hopital Nord Laënnec | Nantes | 44093 | France |
| Hopital Bichat | Paris | 75018 | France |
| CHRU Pontchaillou | Rennes | 35033 | France |
| C.H.U Charles Nicolle | Rouen | 76000 | France |
| CHU Rangueil | Toulouse | 31059 | France |
| Clinique Pasteur / GCVI | Toulouse | 31076 | France |
| Clinique Saint-Gatien | Tours | 37000 | France |
| Zentralklinik Bad Berka GmbH | Bad Berka | 99437 | Germany |
| Universitäts-Herzzentrum Freiburg - Bad Krozingen GmbH | Bad Krozingen | 79189 | Germany |
| Kerckhoff Klinik | Bad Nauheim | 61231 | Germany |
| Herz- und Gefäss-Klinik GmbH | Bad Neustadt an der Saale | 97616 | Germany |
| Herz- und Diabeteszentrum NRW | Bad Oyenhausen | 32545 | Germany |
| Evangelisch Freikirchliches Krankenhaus | Bernau | 16321 | Germany |
| Universitätsklinikum | Cologne | 50937 | Germany |
| Städtisches Klinikum | Dortmund | 44137 | Germany |
| Herzzentrum Dresden GmbH Universitätsklinik | Dresden | 01307 | Germany |
| Universitätsklinik Erlangen | Erlangen | 91054 | Germany |
| Universitätsklinikum Essen | Essen | 45147 | Germany |
| Universitatsmedizin Gottingen | Göttingen | 37075 | Germany |
| Asklepios Klinik St Georg | Hamburg | 20099 | Germany |
| Universitatsklinikum Eppendorf | Hamburg | 20246 | Germany |
| Universitätsklinikum | Jena | 07747 | Germany |
| KLINIKUM KARLSBURG der Klinikgruppe Dr. Guth GmbH & Co. KG | Karlsburg | 17495 | Germany |
| Städtisches Klinikum Karlsruhe | Karlsruhe | 76133 | Germany |
| Universitätsklinikum Schleswig-Holstein, Campus Kiel | Kiel | 24105 | Germany |
| Herzzentrum Leipzig GmbH | Leipzig | 04289 | Germany |
| Johannes Gutenberg Universität Mainz | Mainz | 55131 | Germany |
| Deutsches Herzzentrum Muenchen | Munich | 80636 | Germany |
| Klinikum Schwabing | Munich | 80804 | Germany |
| Klinikum der Universität München - Großhadern | Munich | 81377 | Germany |
| Klinikum Bogenhausen | Munich | 81925 | Germany |
| Universitätsklinikum Münster | Münster | 48149 | Germany |
| Klinikum Sud Nurnberg | Nuremberg | 90471 | Germany |
| Universitatsklinikum Regensburg | Regensburg | 93053 | Germany |
| SANA Herzzentrum | Stuttgart | 70174 | Germany |
| Universitatsklinik Wurzburg | Würzburg | 97080 | Germany |
| Hygeia Hospital | Athens | 15123 | Greece |
| Rambam Medical Center | Haifa | 31095 | Israel |
| Shaare Zedek | Jerusalem | 91031 | Israel |
| Rabin Medical Center | Petah Tikva | 49100 | Israel |
| The Chaim Sheba Medical Center | Tel Litwinsky | 52621 | Israel |
| Clinica Sant'Anna Hospital | Catanzaro | 83100 | Italy |
| Ospedale Pasquinucci | Massa | 54100 | Italy |
| Clinica Montevergine | Mercogliano | 83013 | Italy |
| Ospedale San Raffaele | Milan | 20132 | Italy |
| Centro Cardiologico Monzino | Milan | 20138 | Italy |
| Hesperia Hospital | Modena | 41125 | Italy |
| Azienda Ospedaliera Policlinico Universitario | Padova | 35128 | Italy |
| Istituto Clinico Humanitas | Rozzano Milano | 20089 | Italy |
| Ospedale San Giovanni Battista | Torino | 10126 | Italy |
| Maastricht UMC+ | Maastricht | 6202 AZ | Netherlands |
| Universitetssykehuset Nord-Norge | Tromsø | 9038 | Norway |
| The Cardinal Stefan Wyszyński Institute of Cardiology | Warsaw | 04-628 | Poland |
| Sunninghill Hospital | Johannesburg | Gauteng | 2157 | South Africa |
| St Augustine's Hospital | Durban | 4001 | South Africa |
| Panorama Medi-Clinic | Grand Rapids | 7506 | South Africa |
| UNITAS Hospital | Pretoria | South Africa |
| Vergelegen Medi-Clinic | Somerset West | 7130 | South Africa |
| C.H.U. A Coruña | A Coruña | 15006 | Spain |
| Hospital Clinic de Barcelona | Barcelona | 08036 | Spain |
| Hospital Universitario Vall Hebron | Barcelona | 8035 | Spain |
| Policlinica Gipuzkoa | Donostia / San Sebastian | 20009 | Spain |
| Hospital Clinico San Carlos | Madrid | 28040 | Spain |
| Hospital La Paz | Madrid | 28046 | Spain |
| Hospital Virgen de Arrixaca | Murcia | 30120 | Spain |
| Hospital Marques de Valdecilla | Santander | 39008 | Spain |
| Hospital Virgen Macarena | Seville | 41007 | Spain |
| Complexo Hospitalario Universitario de Vigo | Vigo | 36200 | Spain |
| Inselspital Bern | Bern | 3010 | Switzerland |
| Klinik im Park | Zurich | 8027 | Switzerland |
| London Chest Hospital | London | E2 9JX | United Kingdom |
| St Thomas Hospital | London | SE1 7EH | United Kingdom |
| King's College Hospital NHS Foundation Trust | London | SE5 9RS | United Kingdom |
| St Mary's Hospital - Imperial College Healthcare NHS Trust, Hammersmith Hospital . Du Cane Road | London | W12 0HS | United Kingdom |
| The James Cook University Hospital | Middlesbrough | TS4 3BW | United Kingdom |
| 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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| ID | Term |
|---|---|
| D065467 | Transcatheter Aortic Valve Replacement |
| ID | Term |
|---|---|
| D019918 | Heart Valve Prosthesis Implantation |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019919 | Prosthesis Implantation |
| D019616 | Thoracic Surgical Procedures |
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