SOURCE 3: Observational Study to Evaluate Safety and Performance of SAPIEN 3 THV System in Real Life Practice

CompletedOBSERVATIONAL
Enrollment

2,000

Participants

Timeline

Start Date

July 31, 2014

Primary Completion Date

February 29, 2016

Study Completion Date

November 30, 2020

Conditions
Aortic Stenosis
Interventions
DEVICE

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

Trial Locations (73)

3010

Inselspital Bern, Bern

4031

Universitaetsspital Basel, Basel

4289

Herzzentrum Leipzig GmbH, Leipzig

8027

Klinik im Park Zuerich, Zurich

8032

HerzKlinik Hirslanden HKH - Zuerich, Zurich

8200

Aarhus University Hospital, Skejby, Aarhus

13005

CHU La Timone - Marseille, Marseille

13009

Clinique Clairval - Marseille, Marseille

13285

Hopital Saint Joseph - Marseille, Marseille

16321

Immanuel Klinikum Bernau Herzzentrum Brandenburg, Bernau

17495

Klinikum Karlsburg der Klinikgruppe Dr. Guth GmbH & Co. KG, Karlsburg

20014

Policlinica Gipuzkoa Hospital, San Sebastián

20099

Asklepios Klinik St Georg Hamburg, Hamburg

20132

Ospedale San Raffaele Milano, Milan

20138

Centro Cardiologico Monzino Milano, Milan

20251

Universitares Herzzentrum Hamburg, Hamburg

21079

CHU Bocage - Dijon, Dijon

23795

Herzzentrum Bad Segeberg, Bad Segeberg

24105

Universitaetsklinikum Schleswig Holstein Campus Kiel, Kiel

25000

Hopital Jean Minjoz - Besancon, Besançon

29609

CHU La Cavalle Blanche - Brest, Brest

31059

CHU Rangueil Toulouse, Toulouse

32545

Herz- und Diabeteszentrum NRW - Bad Oeynhausen, Bad Oeynhausen

33000

Clinique Saint-Augustin - Bordeaux, Bordeaux

37000

Clinique Saint-Gatien - Tours, Tours

38700

Centre Hospitalier Universitaire de Grenoble, Grenoble

44800

CHU Nantes-Laennec, Saint-Herblain

47137

Evangelisches Klinikum Niederrhein Herzzentrum Duisburg, Duisburg

48149

Universitaetsklinikum Muenster, Münster

49100

CHU Angers, Angers

49214

Schuechtermann Klinik Bad Rothenfelde, Bad Rothenfelde

50937

Uniklinik Koeln - Herzzentrum, Cologne

53721

Helios Klinikum Siegburg, Siegburg

54000

C.H.U. de Nancy, Nancy

55131

Johannes Gutenberg Universitaet Mainz, Mainz

59000

CHRU Lille, Lille

Polyclinique Bois - Lille, Lille

61231

Kerckhoff-Klinik GmbH Bad Nauheim, Bad Nauheim

63000

CHU Gabriel-Montpied - Clermont Ferrand, Clermont-Ferrand

67000

CHRU Strasbourg, Strasbourg

67063

Klinikum der Stadt Ludwigshafen am Rhein gGmbH, Ludwigshafen

69002

Hospices Civiles de Lyon, Lyon

Hospices Civils de Lyon, Lyon

70376

Robert-Bosch Hospital Stuttgart, Stuttgart

75013

CH Pitie Salpetriere, Paris

75014

Institut Mutualiste Montsouris - Paris, Paris

75018

Hopital Bichat Paris, Paris

76000

CHU Hopital Charles Nicolle Rouen, Rouen

76133

Staedtisches Klinikum Karlsruhe GmbH (SKK), Karlsruhe

78150

Hopital Prive Parly II - Le Chesnay, Le Chesnay

79189

Herz-Zentrum Bad Krozingen, Bad Krozingen

80636

Deutsches Herzzentrum Muenchen (DHM), München

83348

Narodny ustav srdcovych a cievnych chorob, a. s., Bratislava

86156

Klinikum Augsburg, Augsburg

89081

Universitaetsklinikum Ulm, Ulm

90127

Azienda A.R.N.A.S. Ospedale Civico di Palermo, Palermo

91054

Universitaetsklinik Erlangen, Erlangen

91300

Institut Hospitalier Jacques Cartier Massy, Massy

92200

Clinique Ambroise Pare - Neuilly, Neuilly-sur-Seine

92350

Centre Chirurgical Marie Lannelongue - Le Plessis-Robinson, Le Plessis-Robinson

93053

Universitaetsklinikum Regensburg, Regensburg

93200

Centre Cardiologique du Nord - Saint-Denis, Saint-Denis

97616

Herz und Gefaess Klinik - Bad Neustadt, Bad Neustadt an der Saale

99438

Zentralklinik Bad Berka GmbH, Bad Berka

00100

Helsinki University Hospital, Helsinki

90029 OYS

Oulu University Hospital, Oulu

3584 CX

Universitair Medisch Centrum Utrecht, Utrecht

B15 2TH

Queen Elisabeth Hospital Birmingham, Birmingham

CB23 3RE

Papworth Hospital NHS Foundation Trust, Cambridge

EH16 4SA

Royal Infirmary of Edinburgh, Edinburgh

SE17EH

St. Thomas Hospital London, London

SE5 9RS

King´s College Hospital London, London

PL6 8DH

Derriford Hospital Plymouth, Plymouth

Sponsors
All Listed Sponsors
lead

Edwards Lifesciences

INDUSTRY