Severe Aortic StenosisNCT01238497
SOURCE XT REGISTRY
An observational study of Severe Aortic Stenosis, run by Edwards Lifesciences at 104 sites in 18 countries.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Severe Aortic Stenosis
- What is being tested?
- TAVR Implantation of the Transcatheter Aortic Valve Prosthesis
- Type of treatment
- Medical device
- How many people
- 2,954 participants
- Where
- 104 sitesin 18 countries
- Study dates
- Sep 2010to Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with symptomatic aortic stenosis
Who may be able to join
- 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"
Who cannot join
- 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
Trial locations and contacts
104 sites in 18 countries.
104 sites in 18 countries
Germany29 sites
Zentralklinik Bad Berka GmbH
Bad Berka, 99437
Universitäts-Herzzentrum Freiburg - Bad Krozingen GmbH
Bad Krozingen, 79189
Kerckhoff Klinik
Bad Nauheim, 61231
Herz- und Gefäss-Klinik GmbH
Bad Neustadt an der Saale, 97616
Herz- und Diabeteszentrum NRW
Bad Oyenhausen, 32545
Evangelisch Freikirchliches Krankenhaus
Bernau, 16321
Universitätsklinikum
Cologne, 50937
Städtisches Klinikum
Dortmund, 44137
Herzzentrum Dresden GmbH Universitätsklinik
Dresden, 01307
Universitätsklinik Erlangen
Erlangen, 91054
Universitätsklinikum Essen
Essen, 45147
Universitatsmedizin Gottingen
Göttingen, 37075
Asklepios Klinik St Georg
Hamburg, 20099
Universitatsklinikum Eppendorf
Hamburg, 20246
Universitätsklinikum
Jena, 07747
KLINIKUM KARLSBURG der Klinikgruppe Dr. Guth GmbH & Co. KG
Karlsburg, 17495
Städtisches Klinikum Karlsruhe
Karlsruhe, 76133
Universitätsklinikum Schleswig-Holstein, Campus Kiel
Kiel, 24105
Herzzentrum Leipzig GmbH
Leipzig, 04289
Johannes Gutenberg Universität Mainz
Mainz, 55131
Deutsches Herzzentrum Muenchen
Munich, 80636
Klinikum Schwabing
Munich, 80804
Klinikum der Universität München - Großhadern
Munich, 81377
Klinikum Bogenhausen
Munich, 81925
Universitätsklinikum Münster
Münster, 48149
Klinikum Sud Nurnberg
Nuremberg, 90471
Universitatsklinikum Regensburg
Regensburg, 93053
SANA Herzzentrum
Stuttgart, 70174
Universitatsklinik Wurzburg
Würzburg, 97080
France16 sites
CHU Jean Minjoz
Besançon, 25030
CHU La Cavalle Blanche
Brest, 29609
Hôpital Privé Parly II
Le Chesnay, 78150
Centre Chirurgical Marie Lannelongue
Le Plessis-Robinson, 92350
CHU La Timone
Marseille, 13005
Hôpital St Joseph
Marseille, 13008
Clinique Clairval
Marseille, 13009
Institut Hospitalier Jacques Cartier
Massy, 91300
CHU Montpellier - Hôpital Arnaud de Villeneuve
Montpellier, 34295
Hopital Nord Laënnec
Nantes, 44093
Hopital Bichat
Paris, 75018
CHRU Pontchaillou
Rennes, 35033
C.H.U Charles Nicolle
Rouen, 76000
CHU Rangueil
Toulouse, 31059
Clinique Pasteur / GCVI
Toulouse, 31076
Clinique Saint-Gatien
Tours, 37000
Canada10 sites
Foothills Medical Centre
Calgary, Alberta, T2N 2T9
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
Hamilton Health Services
Hamilton, Ontario, L8L 2X2
Montreal Heart Institute
Montreal, Quebec, H1T 1CB
Centre Hospitalier De Universite of Montreal
Montreal, Quebec, H2W 1T8
Southlake Hospital
Newmarket, Ontario, L3Y 2P9
St. John Regional Hospital
Saint John, New Brunswick, E2L 4L2
Hospital Laval
Sainte-Foy, Quebec, G1V 4G5
Toronto General Hospital
Toronto, Ontario, M5G 2C4
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
Spain10 sites
C.H.U. A Coruña
A Coruña, 15006
Hospital Clinic de Barcelona
Barcelona, 08036
Hospital Universitario Vall Hebron
Barcelona, 8035
Policlinica Gipuzkoa
Donostia / San Sebastian, 20009
Hospital Clinico San Carlos
Madrid, 28040
Hospital La Paz
Madrid, 28046
Hospital Virgen de Arrixaca
Murcia, 30120
Hospital Marques de Valdecilla
Santander, 39008
Hospital Virgen Macarena
Seville, 41007
Complexo Hospitalario Universitario de Vigo
Vigo, 36200
Italy9 sites
Clinica Sant'Anna Hospital
Catanzaro, 83100
Ospedale Pasquinucci
Massa, 54100
Clinica Montevergine
Mercogliano, 83013
Ospedale San Raffaele
Milan, 20132
Centro Cardiologico Monzino
Milan, 20138
Hesperia Hospital
Modena, 41125
Azienda Ospedaliera Policlinico Universitario
Padova, 35128
Istituto Clinico Humanitas
Rozzano Milano, 20089
Ospedale San Giovanni Battista
Torino, 10126
South Africa5 sites
St Augustine's Hospital
Durban, 4001
Panorama Medi-Clinic
Grand Rapids, 7506
Sunninghill Hospital
Johannesburg, Gauteng, 2157
UNITAS Hospital
Pretoria
Vergelegen Medi-Clinic
Somerset West, 7130
United Kingdom5 sites
London Chest Hospital
London, E2 9JX
St Thomas Hospital
London, SE1 7EH
King's College Hospital NHS Foundation Trust
London, SE5 9RS
St Mary's Hospital - Imperial College Healthcare NHS Trust, Hammersmith Hospital . Du Cane Road
London, W12 0HS
The James Cook University Hospital
Middlesbrough, TS4 3BW
Belgium4 sites
Onze Lieve Vrouw Ziekenhuis
Aalst, 9300
Clinique St Luc
Bouge, 5004
Cliniques Universitaires Saint Luc
Brussels, 1200
Universitaire Ziekenhuizen Leuven
Leuven, 3000
Israel4 sites
Rambam Medical Center
Haifa, 31095
Shaare Zedek
Jerusalem, 91031
Rabin Medical Center
Petah Tikva, 49100
The Chaim Sheba Medical Center
Tel HaShomer, 52621
Austria2 sites
Universitatsklinik Innsbruck
Innsbruck, 6020
Medical University Vienna
Vienna, 1090
Finland2 sites
Helsinki University Central Hospital
Helsinki, FIN-00029 HUS
Tampere University Hospital
Tampere, 33521
Poland1 site
The Cardinal Stefan Wyszyński Institute of Cardiology
Warsaw, 04-628
About this study
Official title: 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.
Read the 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.
- Conditions
- Severe Aortic Stenosis
- Being tested
- TAVR Implantation of the Transcatheter Aortic Valve Prosthesis
- Keywords
- SAPIEN XT™, Transfemoral, NovaFlex, NovaFlex+, NF, NF+, Transapical, Transaortic, Ascendra2, Ascendra+, Asc+, aortic stenosis, aortic valve, Transcatheter Heart Valve, THV
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAVR Implantation of the Transcatheter Aortic Valve ProsthesisDevice
Also called TAVI Transcatheter Aortic Valve Implantation
Patients eligible for either transfemoral or transapical access and any of the 3 valve sizes (23, 26 or 29)
TAVR Implantation of the Transcatheter Aortic Valve ProsthesisDevice
Also called TAVI Transcatheter Aortic Valve Implantation
Patients eligible for transapical or transaortic access and any of the 3 valve sizes (23mm, 26mm or 29mm)
TAVR Implantation of the Transcatheter Aortic Valve ProsthesisDevice
Also called TAVI Transcatheter Aortic Valve Implantation
Patients eligible for transfemoral access and requiring a 29mm valve.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis | |
| 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) Receives: Device: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis | |
| Registry 3 - NovaFlex+ 29 mm | Registry 3: All patients implanted with a SAPIEN XT valve, 29mm only, via Transfemoral access using NovaFlex+ Receives: Device: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess and track causality and sequelae of major adverse events
Measured: 30 days
Secondary outcomes (1)
Effectiveness: observe trends in patient characteristics and outcomes over time
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2010 (estimated)
- Study startSep 2010
- Primary completionAug 2014
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe Aortic StenosisStudies of the same condition, open and under way.
- More trials run by Edwards LifesciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,954 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Olaf Wendler, MD, PhD, FRCS, Principal investigator, olaf.wendler@kch.nhs.uk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01238497
- Sponsor's protocol ID
- 2010-10
- Status last verified
- Aug 2020
- First submitted
- 26 Oct 2010
- Last updated
- 28 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Schymik G, Lefevre T, Bartorelli AL, Rubino P, Treede H, Walther T, Baumgartner H, Windecker S, Wendler O, Urban P, Mandinov L, Thomas M, Vahanian A. European experience with the second-generation Edwards SAPIEN XT transcatheter heart valve in patients with severe aortic stenosis: 1-year outcomes from the SOURCE XT Registry. JACC Cardiovasc Interv. 2015 Apr 27;8(5):657-69. doi: 10.1016/j.jcin.2014.10.026.
PubMed 25946437
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Edwards SAPIEN™ Aortic Bioprosthesis Multi-Region Outcome Registry XT
- ClinicalTrials.gov ID
- NCT01238497
- Acronym / sponsor ID
- 2010-10
- Conditions
- Severe Aortic Stenosis
- Keywords
- SAPIEN XT™, Transfemoral, NovaFlex, NovaFlex+, NF, NF+, Transapical, Transaortic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,954 participants (actual)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- Sep 2010 (actual)
- Primary completion
- Aug 2014 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 10 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Registry 1 - SOURCE XT | – | Device: TAVR Implantation of the Transcatheter Aortic Valve ProsthesisRegistry 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) |
| Registry 2 - Ascendra+ | – | Device: TAVR Implantation of the Transcatheter Aortic Valve ProsthesisRegistry 2: All patients implanted with a SAPIEN XT Valve, via Transapical or Transaortic access using Ascendra+ delivery system (23mm, 26mm and 29mm valve) |
| Registry 3 - NovaFlex+ 29 mm | – | Device: TAVR Implantation of the Transcatheter Aortic Valve ProsthesisRegistry 3: All patients implanted with a SAPIEN XT valve, 29mm only, via Transfemoral access using NovaFlex+ |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with symptomatic aortic stenosis
Key inclusion criteria (1 listed)
- 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"
Key exclusion criteria (7 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAVR Implantation of the Transcatheter Aortic Valve ProsthesisAlso: TAVI Transcatheter Aortic Valve ImplantationPatients eligible for either transfemoral or transapical access and any of the 3 valve sizes (23, 26 or 29) | Device | Registry 1 - SOURCE XT |
| TAVR Implantation of the Transcatheter Aortic Valve ProsthesisAlso: TAVI Transcatheter Aortic Valve ImplantationPatients eligible for transapical or transaortic access and any of the 3 valve sizes (23mm, 26mm or 29mm) | Device | Registry 2 - Ascendra+ |
| TAVR Implantation of the Transcatheter Aortic Valve ProsthesisAlso: TAVI Transcatheter Aortic Valve ImplantationPatients eligible for transfemoral access and requiring a 29mm valve. | Device | Registry 3 - NovaFlex+ 29 mm |
Primary outcome
Assess and track causality and sequelae of major adverse events
Time frame: 30 days
1 secondary outcome
Effectiveness: observe trends in patient characteristics and outcomes over time
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2020.
- Derived from this study: PubMed 25946437Schymik G, Lefevre T, Bartorelli AL, Rubino P, Treede H, Walther T, Baumgartner H, Windecker S, Wendler O, Urban P, Mandinov L, Thomas M, Vahanian A. European experience with the second-generation Edwards SAPIEN XT transcatheter heart valve in patients with severe aortic stenosis: 1-year outcomes from the SOURCE XT Registry. JACC Cardiovasc Interv. 2015 Apr 27;8(5):657-69. doi: 10.1016/j.jcin.2014.10.026.
Related trials for Severe Aortic Stenosis
RecruitingObservational study
Spanish Prospective Registry of Hydra THV for Transcatheter Aortic Valve Implantation
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PERFECT - Portuguese Evolut Registry Studying the Outcomes of Medtronic Evolut™ FX+ TAVI System by Evaluating an Optimal Care Pathway for TAVI
Severe Symptomatic Aortic Stenosis (Defined as New York Heart Association (NYHA) Class ≥ II)
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Assessment of Coronary Artery Disease Before Transcatheter Aortic Valve Replacement: A Randomized, Multicenter, Non-Inferiority Trial
Aortic Valve Stenosis and Insufficiency, Coronary Artery Disease(CAD)
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A Study to Obtain Imaging Data in 40 Patients Having Transcatheter Aortic Valve Implantation (TAVI)
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Enrolling by invitation
Promoting Shared Decision Making for Severe Aortic Stenosis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olaf Wendler, MD, PhD, FRCS principal investigator
olaf.wendler@kch.nhs.uk
104 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Aortic Stenosis, run by Edwards Lifesciences at 104 sites in 18 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 104 sites in Germany, France, Canada, Spain, Italy and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess and track causality and sequelae of major adverse events (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01238497, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2020.