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SOURCE XT REGISTRY

Sponsor
Edwards Lifesciences (Industry)
Overall Status
Completed
CT.gov ID
NCT01238497
Collaborator
(none)
2,954
Enrollment
104
Locations
74
Actual Duration (Months)
28.4
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis
  • Device: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis
  • Device: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis

Detailed Description

Consecutive patient data should be collected at discharge, 30 days and 12 months post-implant. Subsets of patients may undergo additional follow-up.

Study Design

Study Type:
Observational
Actual Enrollment :
2954 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Edwards SAPIEN™ Aortic Bioprosthesis Multi-Region Outcome Registry XT
Actual Study Start Date :
Sep 1, 2010
Actual Primary Completion Date :
Aug 1, 2014
Actual Study Completion Date :
Nov 1, 2016

Arms and Interventions

Arm Intervention/Treatment
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)

Device: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis
Patients eligible for either transfemoral or transapical access and any of the 3 valve sizes (23, 26 or 29)
Other Names:
  • TAVI Transcatheter Aortic Valve Implantation

    		•
    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)

    Device: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis
    Patients eligible for transapical or transaortic access and any of the 3 valve sizes (23mm, 26mm or 29mm)
    Other Names:
  • TAVI Transcatheter Aortic Valve Implantation

    		•
    Registry 3 - NovaFlex+ 29 mm

    Registry 3: All patients implanted with a SAPIEN XT valve, 29mm only, via Transfemoral access using NovaFlex+

    Device: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis
    Patients eligible for transfemoral access and requiring a 29mm valve.
    Other Names:
  • TAVI Transcatheter Aortic Valve Implantation

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Assess and track causality and sequelae of major adverse events [30 days]

    Secondary Outcome Measures

    1. Effectiveness: observe trends in patient characteristics and outcomes over time [One year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • The SAPIEN XT™ THV is indicated for use in patients with symptomatic aortic stenosis requiring TAVI who have a high risk for operative mortality, or are "non-operable"
    Exclusion Criteria:

    • Non-valvular or congenital aortic stenosis

    • Pre-existing prosthetic heart valve in the Aortic position or a non-calcified aortic valve

    • Severe (>3+) mitral insufficiency or aortic regurgitation > 3+

    • Active bacterial endocarditis or other active infections

    • Severe ventricular dysfunction with ejection fraction < 20%

    • Coronary artery disease-related unstable angina

    • Inability to tolerate anticoagulation / antiplatelet therapy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Universitatsklinik Innsbruck Innsbruck Austria 6020
    2 Medical University Vienna Vienna Austria 1090
    3 Onze Lieve Vrouw Ziekenhuis Aalst Belgium 9300
    4 Clinique St Luc Bouge Belgium 5004
    5 Cliniques Universitaires Saint Luc Brussels Belgium 1200
    6 Universitaire Ziekenhuizen Leuven Leuven Belgium 3000
    7 Foothills Medical Centre Calgary Alberta Canada T2N 2T9
    8 University of Alberta Hospital Edmonton Alberta Canada T6G 2B7
    9 St. Paul's Hospital Vancouver British Columbia Canada V6Z 1Y6
    10 St. John Regional Hospital Saint John New Brunswick Canada E2L 4L2
    11 Hamilton Health Services Hamilton Ontario Canada L8L 2X2
    12 Southlake Hospital Newmarket Ontario Canada L3Y 2P9
    13 Toronto General Hospital Toronto Ontario Canada M5G 2C4
    14 Montreal Heart Institute Montreal Quebec Canada H1T 1CB
    15 Centre Hospitalier De Universite of Montreal Montreal Quebec Canada H2W 1T8
    16 Hospital Laval Sainte-Foy Quebec Canada G1V 4G5
    17 University of Hradec Kralove Hradec Kralove Czechia 5005 05
    18 Aarhus University Hospital Aarhus Denmark 8200
    19 Helsinki University Central Hospital Helsinki Finland FIN-00029 HUS
    20 Tampere University Hospital Tampere Finland 33521
    21 CHU Jean Minjoz Besançon France 25030
    22 CHU La Cavalle Blanche Brest France 29609
    23 Hôpital Privé Parly II Le Chesnay France 78150
    24 Centre Chirurgical Marie Lannelongue Le Plessis Robinson France 92350
    25 CHU La Timone Marseille France 13005
    26 Hôpital St Joseph Marseille France 13008
    27 Clinique Clairval Marseille France 13009
    28 Institut Hospitalier Jacques Cartier Massy France 91300
    29 CHU Montpellier - Hôpital Arnaud de Villeneuve Montpellier France 34295
    30 Hopital Nord Laënnec Nantes France 44093
    31 Hopital Bichat Paris France 75018
    32 CHRU Pontchaillou Rennes France 35033
    33 C.H.U Charles Nicolle Rouen France 76000
    34 CHU Rangueil Toulouse France 31059
    35 Clinique Pasteur / GCVI Toulouse France 31076
    36 Clinique Saint-Gatien Tours France 37000
    37 Zentralklinik Bad Berka GmbH Bad Berka Germany 99437
    38 Universitäts-Herzzentrum Freiburg - Bad Krozingen GmbH Bad Krozingen Germany 79189
    39 Kerckhoff Klinik Bad Nauheim Germany 61231
    40 Herz- und Gefäss-Klinik GmbH Bad Neustadt Germany 97616
    41 Herz- und Diabeteszentrum NRW Bad Oyenhausen Germany 32545
    42 Evangelisch Freikirchliches Krankenhaus Bernau Germany 16321
    43 Städtisches Klinikum Dortmund Germany 44137
    44 Herzzentrum Dresden GmbH Universitätsklinik Dresden Germany 01307
    45 Universitätsklinik Erlangen Erlangen Germany 91054
    46 Universitätsklinikum Essen Essen Germany 45147
    47 Universitatsmedizin Gottingen Goettingen Germany 37075
    48 Asklepios Klinik St Georg Hamburg Germany 20099
    49 Universitatsklinikum Eppendorf Hamburg Germany 20246
    50 Universitätsklinikum Jena Germany 07747
    51 KLINIKUM KARLSBURG der Klinikgruppe Dr. Guth GmbH & Co. KG Karlsburg Germany 17495
    52 Städtisches Klinikum Karlsruhe Karlsruhe Germany 76133
    53 Universitätsklinikum Schleswig-Holstein, Campus Kiel Kiel Germany 24105
    54 Universitätsklinikum Köln Germany 50937
    55 Herzzentrum Leipzig GmbH Leipzig Germany 04289
    56 Johannes Gutenberg Universität Mainz Mainz Germany 55131
    57 Universitätsklinikum Münster Muenster Germany 48149
    58 Deutsches Herzzentrum Muenchen Munich Germany 80636
    59 Klinikum Schwabing Munich Germany 80804
    60 Klinikum der Universität München - Großhadern Munich Germany 81377
    61 Klinikum Bogenhausen Munich Germany 81925
    62 Klinikum Sud Nurnberg Nurnberg Germany 90471
    63 Universitatsklinikum Regensburg Regensburg Germany 93053
    64 SANA Herzzentrum Stuttgart Germany 70174
    65 Universitatsklinik Wurzburg Wurzburg Germany 97080
    66 Hygeia Hospital Athens Greece 15123
    67 Rambam Medical Center Haifa Israel 31095
    68 Shaare Zedek Jerusalem Israel 91031
    69 Rabin Medical Center Petach Tikva Israel 49100
    70 The Chaim Sheba Medical Center Tel Hashomer Israel 52621
    71 Clinica Sant'Anna Hospital Catanzaro Italy 83100
    72 Ospedale Pasquinucci Massa Italy 54100
    73 Clinica Montevergine Mercogliano Italy 83013
    74 Ospedale San Raffaele Milano Italy 20132
    75 Centro Cardiologico Monzino Milano Italy 20138
    76 Hesperia Hospital Modena Italy 41125
    77 Azienda Ospedaliera Policlinico Universitario Padova Italy 35128
    78 Istituto Clinico Humanitas Rozzano Milano Italy 20089
    79 Ospedale San Giovanni Battista Torino Italy 10126
    80 Maastricht UMC+ Maastricht Netherlands 6202 AZ
    81 Universitetssykehuset Nord-Norge Tromso Norway 9038
    82 The Cardinal Stefan Wyszyński Institute of Cardiology Warsaw Poland 04-628
    83 Sunninghill Hospital Johannesburg Gauteng South Africa 2157
    84 St Augustine's Hospital Durban South Africa 4001
    85 Panorama Medi-Clinic Grand Rapids South Africa 7506
    86 UNITAS Hospital Pretoria South Africa
    87 Vergelegen Medi-Clinic Somerset West South Africa 7130
    88 C.H.U. A Coruña A Coruña Spain 15006
    89 Hospital Clinic de Barcelona Barcelona Spain 08036
    90 Hospital Universitario Vall Hebron Barcelona Spain 8035
    91 Hospital Clinico San Carlos Madrid Spain 28040
    92 Hospital La Paz Madrid Spain 28046
    93 Hospital Virgen de Arrixaca Murcia Spain 30120
    94 Policlinica Gipuzkoa San Sebastian Spain 20009
    95 Hospital Marques de Valdecilla Santander Spain 39008
    96 Hospital Virgen Macarena Sevilla Spain 41007
    97 Complexo Hospitalario Universitario de Vigo Vigo Spain 36200
    98 Inselspital Bern Bern Switzerland 3010
    99 Klinik im Park Zurich Switzerland 8027
    100 London Chest Hospital London United Kingdom E2 9JX
    101 St Thomas Hospital London United Kingdom SE1 7EH
    102 King's College Hospital NHS Foundation Trust London United Kingdom SE5 9RS
    103 St Mary's Hospital - Imperial College Healthcare NHS Trust, Hammersmith Hospital . Du Cane Road London United Kingdom W12 0HS
    104 The James Cook University Hospital Middlesbrough United Kingdom TS4 3BW

    Sponsors and Collaborators

    • Edwards Lifesciences

    Investigators

    • Principal Investigator: Olaf Wendler, MD, PhD, FRCS, olaf.wendler@kch.nhs.uk

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Edwards Lifesciences
    ClinicalTrials.gov Identifier:
    NCT01238497
    Other Study ID Numbers:
    • 2010-10
    First Posted:
    Nov 10, 2010
    Last Update Posted:
    Aug 28, 2020
    Last Verified:
    Aug 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Keywords provided by Edwards Lifesciences
    SAPIEN XT™
    Transfemoral
    NovaFlex
    NovaFlex+
    NF
    NF+
    Transapical
    Transaortic
    Ascendra2
    Ascendra+
    Asc+
    aortic stenosis
    aortic valve
    Transcatheter Heart Valve
    THV
    Additional relevant MeSH terms:
    Aortic Valve Stenosis

    Study Results

    No Results Posted as of Aug 28, 2020