SOURCE XT REGISTRY

August 26, 2020 updated by: Edwards Lifesciences

Edwards SAPIEN™ Aortic Bioprosthesis Multi-Region Outcome Registry XT

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

2954

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria, 6020
        • Universitatsklinik Innsbruck
      • Vienna, Austria, 1090
        • Medical University Vienna
  • Belgium
      • Aalst, Belgium, 9300
        • Onze Lieve Vrouw Ziekenhuis
      • Bouge, Belgium, 5004
        • Clinique St Luc
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint Luc
      • Leuven, Belgium, 3000
        • Universitaire Ziekenhuizen Leuven
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Foothills Medical Centre
      • Edmonton, Alberta, Canada, T6G 2B7
        • University of Alberta Hospital
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • St. Paul's Hospital
    • New Brunswick
      • Saint John, New Brunswick, Canada, E2L 4L2
        • St. John Regional Hospital
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Hamilton Health Services
      • Newmarket, Ontario, Canada, L3Y 2P9
        • Southlake Hospital
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto General Hospital
    • Quebec
      • Montreal, Quebec, Canada, H1T 1CB
        • Montreal Heart Institute
      • Montreal, Quebec, Canada, H2W 1T8
        • Centre Hospitalier De Universite of Montreal
      • Sainte-Foy, Quebec, Canada, G1V 4G5
        • Hospital Laval
  • Czechia
      • Hradec Kralove, Czechia, 5005 05
        • University of Hradec Kralove
  • Denmark
      • Aarhus, Denmark, 8200
        • Aarhus University Hospital
  • Finland
      • Helsinki, Finland, FIN-00029 HUS
        • Helsinki University Central Hospital
      • Tampere, Finland, 33521
        • Tampere University Hospital
  • France
      • Besançon, France, 25030
        • Chu Jean Minjoz
      • Brest, France, 29609
        • CHU La Cavalle Blanche
      • Le Chesnay, France, 78150
        • Hôpital Privé Parly II
      • Le Plessis Robinson, France, 92350
        • Centre chirurgical Marie Lannelongue
      • Marseille, France, 13009
        • Clinique Clairval
      • Marseille, France, 13005
        • CHU La Timone
      • Marseille, France, 13008
        • Hôpital St Joseph
      • Massy, France, 91300
        • Institut Hospitalier Jacques Cartier
      • Montpellier, France, 34295
        • CHU Montpellier - Hôpital Arnaud de Villeneuve
      • Nantes, France, 44093
        • Hopital Nord Laennec
      • Paris, France, 75018
        • Hôpital Bichat
      • Rennes, France, 35033
        • Chru Pontchaillou
      • Rouen, France, 76000
        • C.H.U Charles Nicolle
      • Toulouse, France, 31059
        • CHU Rangueil
      • Toulouse, France, 31076
        • Clinique Pasteur / GCVI
      • Tours, France, 37000
        • Clinique Saint-Gatien
  • Germany
      • Bad Berka, Germany, 99437
        • Zentralklinik Bad Berka GmbH
      • Bad Krozingen, Germany, 79189
        • Universitäts-Herzzentrum Freiburg - Bad Krozingen GmbH
      • Bad Nauheim, Germany, 61231
        • Kerckhoff Klinik
      • Bad Neustadt, Germany, 97616
        • Herz- und Gefäß-Klinik GmbH
      • Bad Oyenhausen, Germany, 32545
        • Herz- und Diabeteszentrum NRW
      • Bernau, Germany, 16321
        • Evangelisch Freikirchliches Krankenhaus
      • Dortmund, Germany, 44137
        • Städtisches Klinikum
      • Dresden, Germany, 01307
        • Herzzentrum Dresden GmbH Universitätsklinik
      • Erlangen, Germany, 91054
        • Universitätsklinik Erlangen
      • Essen, Germany, 45147
        • Universitätsklinikum Essen
      • Goettingen, Germany, 37075
        • Universitatsmedizin Gottingen
      • Hamburg, Germany, 20246
        • Universitätsklinikum Eppendorf
      • Hamburg, Germany, 20099
        • Asklepios Klinik St Georg
      • Jena, Germany, 07747
        • Universitätsklinikum
      • Karlsburg, Germany, 17495
        • KLINIKUM KARLSBURG der Klinikgruppe Dr. Guth GmbH & Co. KG
      • Karlsruhe, Germany, 76133
        • Stadtisches Klinikum Karlsruhe
      • Kiel, Germany, 24105
        • Universitatsklinikum Schleswig-Holstein, Campus Kiel
      • Köln, Germany, 50937
        • Universitätsklinikum
      • Leipzig, Germany, 04289
        • Herzzentrum Leipzig GmbH
      • Mainz, Germany, 55131
        • Johannes Gutenberg Universität Mainz
      • Muenster, Germany, 48149
        • Universitätsklinikum Münster
      • Munich, Germany, 80636
        • Deutsches Herzzentrum Muenchen
      • Munich, Germany, 81925
        • Klinikum Bogenhausen
      • Munich, Germany, 80804
        • Klinikum Schwabing
      • Munich, Germany, 81377
        • Klinikum der Universitat Munchen - Grosshadern
      • Nurnberg, Germany, 90471
        • Klinikum Sud Nurnberg
      • Regensburg, Germany, 93053
        • Universitätsklinikum Regensburg
      • Stuttgart, Germany, 70174
        • SANA Herzzentrum
      • Wurzburg, Germany, 97080
        • Universitätsklinik Würzburg
  • Greece
      • Athens, Greece, 15123
        • Hygeia Hospital
  • Israel
      • Haifa, Israel, 31095
        • Rambam Medical Center
      • Jerusalem, Israel, 91031
        • Shaare Zedek
      • Petach Tikva, Israel, 49100
        • Rabin Medical Center
      • Tel Hashomer, Israel, 52621
        • The Chaim Sheba Medical Center
  • Italy
      • Catanzaro, Italy, 83100
        • Clinica Sant'Anna Hospital
      • Massa, Italy, 54100
        • Ospedale Pasquinucci
      • Mercogliano, Italy, 83013
        • Clinica Montevergine
      • Milano, Italy, 20132
        • Ospedale San Raffaele
      • Milano, Italy, 20138
        • Centro Cardiologico Monzino
      • Modena, Italy, 41125
        • Hesperia Hospital
      • Padova, Italy, 35128
        • Azienda Ospedaliera Policlinico Universitario
      • Rozzano Milano, Italy, 20089
        • Istituto Clinico Humanitas
      • Torino, Italy, 10126
        • Ospedale San Giovanni Battista
  • Netherlands
      • Maastricht, Netherlands, 6202 AZ
        • Maastricht UMC+
  • Norway
      • Tromso, Norway, 9038
        • Universitetssykehuset Nord-Norge
  • Poland
      • Warsaw, Poland, 04-628
        • The Cardinal Stefan Wyszynski Institute of Cardiology
  • South Africa
      • Durban, South Africa, 4001
        • St Augustine's Hospital
      • Grand Rapids, South Africa, 7506
        • Panorama Medi-Clinic
      • Pretoria, South Africa
        • Unitas Hospital
      • Somerset West, South Africa, 7130
        • Vergelegen Medi-Clinic
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2157
        • Sunninghill Hospital
  • Spain
      • A Coruña, Spain, 15006
        • C.H.U. A Coruña
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona
      • Barcelona, Spain, 8035
        • Hospital Universitario Vall Hebrón
      • Madrid, Spain, 28040
        • Hospital Clínico San Carlos
      • Madrid, Spain, 28046
        • Hospital La Paz
      • Murcia, Spain, 30120
        • Hospital Virgen de Arrixaca
      • San Sebastian, Spain, 20009
        • Policlinica Gipuzkoa
      • Santander, Spain, 39008
        • Hospital Marques de Valdecilla
      • Sevilla, Spain, 41007
        • Hospital Virgen Macarena
      • Vigo, Spain, 36200
        • Complexo Hospitalario Universitario de Vigo
  • Switzerland
      • Bern, Switzerland, 3010
        • Inselspital Bern
      • Zurich, Switzerland, 8027
        • Klinik im Park
  • United Kingdom
      • London, United Kingdom, E2 9JX
        • London Chest Hospital
      • London, United Kingdom, SE5 9RS
        • King's College Hospital NHS Foundation Trust
      • London, United Kingdom, SE1 7EH
        • St Thomas Hospital
      • London, United Kingdom, W12 0HS
        • St Mary's Hospital - Imperial College Healthcare NHS Trust, Hammersmith Hospital . Du Cane Road
      • Middlesbrough, United Kingdom, TS4 3BW
        • The James Cook University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with symptomatic aortic stenosis

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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
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
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
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 either transfemoral or transapical access and any of the 3 valve sizes (23, 26 or 29)
Other Names:
  • TAVI Transcatheter Aortic Valve Implantation
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
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
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 either transfemoral or transapical access and any of the 3 valve sizes (23, 26 or 29)
Other Names:
  • TAVI Transcatheter Aortic Valve Implantation
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assess and track causality and sequelae of major adverse events
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Effectiveness: observe trends in patient characteristics and outcomes over time
Time Frame: One year
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Edwards Lifesciences

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2010

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

October 26, 2010

First Submitted That Met QC Criteria

November 9, 2010

First Posted (Estimate)

November 10, 2010

Study Record Updates

Last Update Posted (Actual)

August 28, 2020

Last Update Submitted That Met QC Criteria

August 26, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-10 (Other Identifier: CCRRC)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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