SOURCE 3: Observational Study to Evaluate Safety and Performance of SAPIEN 3 THV System in Real Life Practice
NCT ID: NCT02698956
Last Updated: 2021-03-16
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
2000 participants
OBSERVATIONAL
2014-07-31
2020-11-30
Brief Summary
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300 patients out of the 2000 patients enrolled in the main registry are planned to be consecutively enrolled in a select few sites for studying the valve performance. Echocardiogram and angiogram will be taken routinely.
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Detailed Description
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Consecutive patient data will be collected at baseline, procedure, discharge, after discharge (at approx. 30 days post-index procedure), 12 months post-index procedure and annually thereafter up to 5 years post-implant according to usual practice at site.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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TAVI (Transcatheter Aortic Valve Implantation)
Edwards SAPIEN 3 Transcatheter Heart Valve (S3 THV) and Edwards Commander Delivery system (transfemoral) and Certitude Delivery system (transapical/transaortic). The Edwards S3 THV is indicated for use in patients with severe, symptomatic, calcific aortic stenosis with STS Score ≥ 8 or Logistic EuroSCORE ≥15
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* STS Score ≥ 8
* Logistic EuroSCORE ≥15
Exclusion Criteria
* Evidence of intracardiac mass, thrombus or vegetation
* Active infection or endocarditis
ALL
No
Sponsors
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Edwards Lifesciences
INDUSTRY
Responsible Party
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Principal Investigators
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Prof. Dr. Olaf Wendler, MD
Role: PRINCIPAL_INVESTIGATOR
King's College Hospital NHS Trust
Prof. Dr. Alec Vahanian, MD
Role: PRINCIPAL_INVESTIGATOR
Hopital Bichat, Paris
Locations
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Aarhus University Hospital, Skejby
Aarhus, , Denmark
Helsinki University Hospital
Helsinki, , Finland
Oulu University Hospital
Oulu, , Finland
CHU Angers
Angers, , France
Hopital Jean Minjoz - Besancon
Besançon, , France
Clinique Saint-Augustin - Bordeaux
Bordeaux, , France
CHU La Cavalle Blanche - Brest
Brest, , France
CHU Gabriel-Montpied - Clermont Ferrand
Clermont-Ferrand, , France
CHU Bocage - Dijon
Dijon, , France
Centre Hospitalier Universitaire de Grenoble
Grenoble, , France
Hopital Prive Parly II - Le Chesnay
Le Chesnay, , France
Centre Chirurgical Marie Lannelongue - Le Plessis-Robinson
Le Plessis-Robinson, , France
CHRU Lille
Lille, , France
Polyclinique Bois - Lille
Lille, , France
Hospices Civiles de Lyon
Lyon, , France
Hospices Civils de Lyon
Lyon, , France
CHU La Timone - Marseille
Marseille, , France
Clinique Clairval - Marseille
Marseille, , France
Hopital Saint Joseph - Marseille
Marseille, , France
Institut Hospitalier Jacques Cartier Massy
Massy, , France
C.H.U. de Nancy
Nancy, , France
Clinique Ambroise Pare - Neuilly
Neuilly-sur-Seine, , France
CH Pitie Salpetriere
Paris, , France
Institut Mutualiste Montsouris - Paris
Paris, , France
Hopital Bichat Paris
Paris, , France
CHU Hopital Charles Nicolle Rouen
Rouen, , France
Centre Cardiologique du Nord - Saint-Denis
Saint-Denis, , France
CHU Nantes-Laennec
Saint-Herblain, , France
CHRU Strasbourg
Strasbourg, , France
CHU Rangueil Toulouse
Toulouse, , France
Clinique Saint-Gatien - Tours
Tours, , France
Klinikum Augsburg
Augsburg, , Germany
Zentralklinik Bad Berka GmbH
Bad Berka, , Germany
Herz-Zentrum Bad Krozingen
Bad Krozingen, , Germany
Kerckhoff-Klinik GmbH Bad Nauheim
Bad Nauheim, , Germany
Herz und Gefaess Klinik - Bad Neustadt
Bad Neustadt an der Saale, , Germany
Herz- und Diabeteszentrum NRW - Bad Oeynhausen
Bad Oeynhausen, , Germany
Schuechtermann Klinik Bad Rothenfelde
Bad Rothenfelde, , Germany
Herzzentrum Bad Segeberg
Bad Segeberg, , Germany
Immanuel Klinikum Bernau Herzzentrum Brandenburg
Bernau, , Germany
Uniklinik Koeln - Herzzentrum
Cologne, , Germany
Evangelisches Klinikum Niederrhein Herzzentrum Duisburg
Duisburg, , Germany
Universitaetsklinik Erlangen
Erlangen, , Germany
Asklepios Klinik St Georg Hamburg
Hamburg, , Germany
Universitares Herzzentrum Hamburg
Hamburg, , Germany
Klinikum Karlsburg der Klinikgruppe Dr. Guth GmbH & Co. KG
Karlsburg, , Germany
Staedtisches Klinikum Karlsruhe GmbH (SKK)
Karlsruhe, , Germany
Universitaetsklinikum Schleswig Holstein Campus Kiel
Kiel, , Germany
Herzzentrum Leipzig GmbH
Leipzig, , Germany
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
Ludwigshafen, , Germany
Johannes Gutenberg Universitaet Mainz
Mainz, , Germany
Deutsches Herzzentrum Muenchen (DHM)
München, , Germany
Universitaetsklinikum Muenster
Münster, , Germany
Universitaetsklinikum Regensburg
Regensburg, , Germany
Helios Klinikum Siegburg
Siegburg, , Germany
Robert-Bosch Hospital Stuttgart
Stuttgart, , Germany
Universitaetsklinikum Ulm
Ulm, , Germany
Ospedale San Raffaele Milano
Milan, , Italy
Centro Cardiologico Monzino Milano
Milan, , Italy
Azienda A.R.N.A.S. Ospedale Civico di Palermo
Palermo, , Italy
Universitair Medisch Centrum Utrecht
Utrecht, , Netherlands
Narodny ustav srdcovych a cievnych chorob, a. s.
Bratislava, , Slovakia
Policlinica Gipuzkoa Hospital
San Sebastián, , Spain
Universitaetsspital Basel
Basel, , Switzerland
Inselspital Bern
Bern, , Switzerland
Klinik im Park Zuerich
Zurich, , Switzerland
HerzKlinik Hirslanden HKH - Zuerich
Zurich, , Switzerland
Queen Elisabeth Hospital Birmingham
Birmingham, , United Kingdom
Papworth Hospital NHS Foundation Trust
Cambridge, , United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, , United Kingdom
St. Thomas Hospital London
London, , United Kingdom
King´s College Hospital London
London, , United Kingdom
Derriford Hospital Plymouth
Plymouth, , United Kingdom
Countries
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References
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Tarantini G, Nai Fovino L, Le Prince P, Darremont O, Urena M, Bartorelli AL, Vincent F, Hovorka T, Alcala Navarro Y, Dumonteil N, Ohlmann P, Wendler O. Coronary Access and Percutaneous Coronary Intervention Up to 3 Years After Transcatheter Aortic Valve Implantation With a Balloon-Expandable Valve. Circ Cardiovasc Interv. 2020 Jul;13(7):e008972. doi: 10.1161/CIRCINTERVENTIONS.120.008972. Epub 2020 Jun 25.
Fernandez-Santos S, Theron A, Pibarot P, Collart F, Gilard M, Urena M, Hovorka T, Kahlert P, Zamorano Gomez JL. Valve hemodynamic performance and myocardial strain after implantation of a third-generation, balloon-expandable, transcatheter aortic valve. Cardiol J. 2020;27(6):789-796. doi: 10.5603/CJ.a2019.0049. Epub 2019 May 20.
Tarantini G, Lefevre T, Terkelsen CJ, Frerker C, Ohlmann P, Mojoli M, Eltchaninoff H, Pinaud F, Redwood S, Windecker S. One-Year Outcomes of a European Transcatheter Aortic Valve Implantation Cohort According to Surgical Risk. Circ Cardiovasc Interv. 2019 Jan;12(1):e006724. doi: 10.1161/CIRCINTERVENTIONS.118.006724.
Frank D, Abdel-Wahab M, Gilard M, Digne F, Souteyrand G, Caussin C, Collart F, Letocart V, Wohrle J, Kuhn C, Hovorka T, Baumgartner H. Characteristics and outcomes of patients </= 75 years who underwent transcatheter aortic valve implantation: insights from the SOURCE 3 Registry. Clin Res Cardiol. 2019 Jul;108(7):763-771. doi: 10.1007/s00392-018-1404-2. Epub 2018 Dec 14.
Wendler O, Schymik G, Treede H, Baumgartner H, Dumonteil N, Neumann FJ, Tarantini G, Zamorano JL, Vahanian A. SOURCE 3: 1-year outcomes post-transcatheter aortic valve implantation using the latest generation of the balloon-expandable transcatheter heart valve. Eur Heart J. 2017 Sep 21;38(36):2717-2726. doi: 10.1093/eurheartj/ehx294.
Other Identifiers
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2014-01
Identifier Type: -
Identifier Source: org_study_id
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