Clinical trial NCT02698956: SOURCE 3: Observational Study to Evaluate Safety and Performance of SAPIEN 3 THV System in Real Life Practice
Official title: Edwards SAPIEN 3 Aortic Bioprosthesis Multi-Region Outcome Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Stenosis
Keywords: SAPIEN 3 THV
TAVI
Transfemoral
Transaortic
Transapical
Aortic valve
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2016-03-04
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering from severe aortic stenosis. Inclusion criteria are based on the decision of the Heart Team.

Brief summary: This is an international, mutli-center, prospective, consecutively enrolled, observational registry. 2000 patients are planned to be enrolled over one year at up to 150 participating sites.

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.

Detailed description: The purpose of this registry is to provide clinical outcome and safety information on patients that will be treated with the Edwards SAPIEN 3 Transcatheter Heart Valve and delivery devices for severe, symptomatic calcific aortic stenosis. In addition, the information collected will serve post market safety and surveillance regulatory obligations.

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.

Eligibility criteria: Inclusion Criteria:

* Patient suffering from severe, symptomatic, calcific aortic stenosis
* STS Score ≥ 8
* Logistic EuroSCORE ≥15

Exclusion Criteria:

* Congenital unicuspid or congenital bicuspid aortic valve
* Evidence of intracardiac mass, thrombus or vegetation
* Active infection or endocarditis

Primary outcomes:
measure: All cause mortality
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital, Skejby
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Angers
country: France
facility: CHU Angers
city: Besancon
country: France
facility: Hopital Jean Minjoz - Besancon
city: Bordeaux
country: France
facility: Clinique Saint-Augustin - Bordeaux
city: Brest
country: France
facility: CHU La Cavalle Blanche - Brest
city: Clermont Ferrand
country: France
facility: CHU Gabriel-Montpied - Clermont Ferrand
city: Dijon
country: France
facility: CHU Bocage - Dijon
city: Grenoble
country: France
facility: Centre Hospitalier Universitaire de Grenoble
city: Le Chesnay
country: France
facility: Hopital Prive Parly II - Le Chesnay
city: Le Plessis-Robinson
country: France
facility: Centre Chirurgical Marie Lannelongue - Le Plessis-Robinson
city: Lille
country: France
facility: CHRU Lille
city: Lille
country: France
facility: Polyclinique Bois - Lille
city: Lyon
country: France
facility: Hospices Civiles de Lyon
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Marseille
country: France
facility: CHU La Timone - Marseille
city: Marseille
country: France
facility: Clinique Clairval - Marseille
city: Marseille
country: France
facility: Hopital Saint Joseph - Marseille
city: Massy
country: France
facility: Institut Hospitalier Jacques Cartier Massy
city: Nancy
country: France
facility: C.H.U. de Nancy
city: Neuilly Sur Seine
country: France
facility: Clinique Ambroise Pare - Neuilly
city: Paris
country: France
facility: CH Pitie Salpetriere
city: Paris
country: France
facility: Institut Mutualiste Montsouris - Paris
city: Paris
country: France
facility: Hopital Bichat Paris
city: Rouen
country: France
facility: CHU Hopital Charles Nicolle Rouen
city: Saint-Denis
country: France
facility: Centre Cardiologique du Nord - Saint-Denis
city: Saint-Herblain
country: France
facility: CHU Nantes-Laennec
city: Strasbourg
country: France
facility: CHRU Strasbourg
city: Toulouse
country: France
facility: CHU Rangueil Toulouse
city: Tours
country: France
facility: Clinique Saint-Gatien - Tours
city: Augsburg
country: Germany
facility: Klinikum Augsburg
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka GmbH
city: Bad Krozingen
country: Germany
facility: Herz-Zentrum Bad Krozingen
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik GmbH Bad Nauheim
city: Bad Neustadt a.d.Saale
country: Germany
facility: Herz und Gefaess Klinik - Bad Neustadt
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum NRW - Bad Oeynhausen
city: Bad Rothenfelde
country: Germany
facility: Schuechtermann Klinik Bad Rothenfelde
city: Bad Segeberg
country: Germany
facility: Herzzentrum Bad Segeberg
city: Bernau
country: Germany
facility: Immanuel Klinikum Bernau Herzzentrum Brandenburg
city: Duisburg
country: Germany
facility: Evangelisches Klinikum Niederrhein Herzzentrum Duisburg
city: Erlangen
country: Germany
facility: Universitaetsklinik Erlangen
city: Hamburg
country: Germany
facility: Asklepios Klinik St Georg Hamburg
city: Hamburg
country: Germany
facility: Universitares Herzzentrum Hamburg
city: Karlsburg
country: Germany
facility: Klinikum Karlsburg der Klinikgruppe Dr. Guth GmbH & Co. KG
city: Karlsruhe
country: Germany
facility: Staedtisches Klinikum Karlsruhe GmbH (SKK)
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig Holstein Campus Kiel
city: Koeln
country: Germany
facility: Uniklinik Koeln - Herzzentrum
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig GmbH
city: Ludwigshafen
country: Germany
facility: Klinikum der Stadt Ludwigshafen am Rhein gGmbH
city: Mainz
country: Germany
facility: Johannes Gutenberg Universitaet Mainz
city: Muenchen
country: Germany
facility: Deutsches Herzzentrum Muenchen (DHM)
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster
city: Regensburg
country: Germany
facility: Universitaetsklinikum Regensburg
city: Siegburg
country: Germany
facility: Helios Klinikum Siegburg
city: Stuttgart
country: Germany
facility: Robert-Bosch Hospital Stuttgart
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm
city: Milano
country: Italy
facility: Ospedale San Raffaele Milano
city: Milano
country: Italy
facility: Centro Cardiologico Monzino Milano
city: Palermo
country: Italy
facility: Azienda A.R.N.A.S. Ospedale Civico di Palermo
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht
city: Bratislava
country: Slovakia
facility: Narodny ustav srdcovych a cievnych chorob, a. s.
city: San Sebastián
country: Spain
facility: Policlinica Gipuzkoa Hospital
city: Basel
country: Switzerland
facility: Universitaetsspital Basel
city: Bern
country: Switzerland
facility: Inselspital Bern
city: Zuerich
country: Switzerland
facility: Klinik im Park Zuerich
city: Zuerich
country: Switzerland
facility: HerzKlinik Hirslanden HKH - Zuerich
city: Birmingham
country: United Kingdom
facility: Queen Elisabeth Hospital Birmingham
city: Cambridge
country: United Kingdom
facility: Papworth Hospital NHS Foundation Trust
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
city: London
country: United Kingdom
facility: St. Thomas Hospital London
city: London
country: United Kingdom
facility: King´s College Hospital London
city: Plymouth
country: United Kingdom
facility: Derriford Hospital Plymouth
Study officials:
affiliation: King's College Hospital NHS Trust
name: Prof. Dr. Olaf Wendler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital Bichat, Paris
name: Prof. Dr. Alec Vahanian, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.