Aortic StenosisSOURCE 3NCT02698956
SOURCE 3: Observational Study to Evaluate Safety and Performance of SAPIEN 3 THV System in Real Life Practice
An observational study of Aortic Stenosis, run by Edwards Lifesciences at 73 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- TAVI (Transcatheter Aortic Valve Implantation)
- Type of treatment
- Medical device
- How many people
- 2,000 participants
- Where
- 73 sitesin 10 countries
- Study dates
- Jul 2014to 30 Nov 2020
- 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 suffering from severe aortic stenosis. Inclusion criteria are based on the decision of the Heart Team.
Who may be able to join
- Patient suffering from severe, symptomatic, calcific aortic stenosis
- STS Score ≥ 8
- Logistic EuroSCORE ≥15
Who cannot join
- Congenital unicuspid or congenital bicuspid aortic valve
- Evidence of intracardiac mass, thrombus or vegetation
- Active infection or endocarditis
Trial locations and contacts
73 sites in 10 countries.
73 sites in 10 countries
France28 sites
CHU Angers
Angers, 49100
Hopital Jean Minjoz - Besancon
Besançon, 25000
Clinique Saint-Augustin - Bordeaux
Bordeaux, 33000
CHU La Cavalle Blanche - Brest
Brest, 29609
CHU Gabriel-Montpied - Clermont Ferrand
Clermont-Ferrand, 63000
CHU Bocage - Dijon
Dijon, 21079
Centre Hospitalier Universitaire de Grenoble
Grenoble, 38700
Hopital Prive Parly II - Le Chesnay
Le Chesnay, 78150
Centre Chirurgical Marie Lannelongue - Le Plessis-Robinson
Le Plessis-Robinson, 92350
CHRU Lille
Lille, 59000
Polyclinique Bois - Lille
Lille, 59000
Hospices Civiles de Lyon
Lyon, 69002
Hospices Civils de Lyon
Lyon, 69002
CHU La Timone - Marseille
Marseille, 13005
Clinique Clairval - Marseille
Marseille, 13009
Hopital Saint Joseph - Marseille
Marseille, 13285
Institut Hospitalier Jacques Cartier Massy
Massy, 91300
C.H.U. de Nancy
Nancy, 54000
Clinique Ambroise Pare - Neuilly
Neuilly-sur-Seine, 92200
CH Pitie Salpetriere
Paris, 75013
Institut Mutualiste Montsouris - Paris
Paris, 75014
Hopital Bichat Paris
Paris, 75018
CHU Hopital Charles Nicolle Rouen
Rouen, 76000
Centre Cardiologique du Nord - Saint-Denis
Saint-Denis, 93200
CHU Nantes-Laennec
Saint-Herblain, 44800
CHRU Strasbourg
Strasbourg, 67000
CHU Rangueil Toulouse
Toulouse, 31059
Clinique Saint-Gatien - Tours
Tours, 37000
Germany26 sites
Klinikum Augsburg
Augsburg, 86156
Zentralklinik Bad Berka GmbH
Bad Berka, 99438
Herz-Zentrum Bad Krozingen
Bad Krozingen, 79189
Kerckhoff-Klinik GmbH Bad Nauheim
Bad Nauheim, 61231
Herz und Gefaess Klinik - Bad Neustadt
Bad Neustadt an der Saale, 97616
Herz- und Diabeteszentrum NRW - Bad Oeynhausen
Bad Oeynhausen, 32545
Schuechtermann Klinik Bad Rothenfelde
Bad Rothenfelde, 49214
Herzzentrum Bad Segeberg
Bad Segeberg, 23795
Immanuel Klinikum Bernau Herzzentrum Brandenburg
Bernau, 16321
Uniklinik Koeln - Herzzentrum
Cologne, 50937
Evangelisches Klinikum Niederrhein Herzzentrum Duisburg
Duisburg, 47137
Universitaetsklinik Erlangen
Erlangen, 91054
Asklepios Klinik St Georg Hamburg
Hamburg, 20099
Universitares Herzzentrum Hamburg
Hamburg, 20251
Klinikum Karlsburg der Klinikgruppe Dr. Guth GmbH & Co. KG
Karlsburg, 17495
Staedtisches Klinikum Karlsruhe GmbH (SKK)
Karlsruhe, 76133
Universitaetsklinikum Schleswig Holstein Campus Kiel
Kiel, 24105
Herzzentrum Leipzig GmbH
Leipzig, 4289
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
Ludwigshafen, 67063
Johannes Gutenberg Universitaet Mainz
Mainz, 55131
Deutsches Herzzentrum Muenchen (DHM)
München, 80636
Universitaetsklinikum Muenster
Münster, 48149
Universitaetsklinikum Regensburg
Regensburg, 93053
Helios Klinikum Siegburg
Siegburg, 53721
Robert-Bosch Hospital Stuttgart
Stuttgart, 70376
Universitaetsklinikum Ulm
Ulm, 89081
United Kingdom6 sites
Queen Elisabeth Hospital Birmingham
Birmingham, B15 2TH
Papworth Hospital NHS Foundation Trust
Cambridge, CB23 3RE
Royal Infirmary of Edinburgh
Edinburgh, EH16 4SA
St. Thomas Hospital London
London, SE17EH
King´s College Hospital London
London, SE5 9RS
Derriford Hospital Plymouth
Plymouth, PL6 8DH
Switzerland4 sites
Universitaetsspital Basel
Basel, 4031
Inselspital Bern
Bern, 3010
Klinik im Park Zuerich
Zurich, 8027
HerzKlinik Hirslanden HKH - Zuerich
Zurich, 8032
Italy3 sites
Ospedale San Raffaele Milano
Milan, 20132
Centro Cardiologico Monzino Milano
Milan, 20138
Azienda A.R.N.A.S. Ospedale Civico di Palermo
Palermo, 90127
Finland2 sites
Helsinki University Hospital
Helsinki, 00100
Oulu University Hospital
Oulu, 90029 OYS
Slovakia1 site
Narodny ustav srdcovych a cievnych chorob, a. s.
Bratislava, 83348
About this study
Official title: Edwards SAPIEN 3 Aortic Bioprosthesis Multi-Region Outcome Registry
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.
Read the 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.
- Conditions
- Aortic Stenosis
- Being tested
- TAVI (Transcatheter Aortic Valve Implantation)
- Keywords
- SAPIEN 3 THV, TAVI, Transfemoral, Transaortic, Transapical, Aortic valve
- 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.
TAVI (Transcatheter Aortic Valve Implantation)Device
Also called TAVR
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
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2016 (estimated)
- Study startJul 2014
- Primary completionFeb 2016
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prof. Dr. Olaf Wendler, MD, Principal investigator, King's College Hospital NHS TrustProf. Dr. Alec Vahanian, MD, Principal investigator, Bichat Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02698956
- Sponsor's protocol ID
- 2014-01
- Acronym
- SOURCE 3
- Status last verified
- Mar 2021
- First submitted
- 27 Feb 2015
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 32580586Fernandez-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.
PubMed 31106841Tarantini 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.
PubMed 30630356Frank 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.
PubMed 30552511Wendler 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.
PubMed 28605423
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Edwards SAPIEN 3 Aortic Bioprosthesis Multi-Region Outcome Registry
- ClinicalTrials.gov ID
- NCT02698956
- Acronym / sponsor ID
- SOURCE 3 / 2014-01
- Conditions
- Aortic Stenosis
- Keywords
- SAPIEN 3 THV, TAVI, Transfemoral, Transaortic, Transapical, Aortic valve
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- Jul 2014 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 4 Mar 2016 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients suffering from severe aortic stenosis. Inclusion criteria are based on the decision of the Heart Team.
Key inclusion criteria (3 listed)
- Patient suffering from severe, symptomatic, calcific aortic stenosis
- STS Score ≥ 8
- Logistic EuroSCORE ≥15
Key exclusion criteria (3 listed)
- Congenital unicuspid or congenital bicuspid aortic valve
- Evidence of intracardiac mass, thrombus or vegetation
- Active infection or endocarditis
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 |
|---|---|---|
| TAVI (Transcatheter Aortic Valve Implantation)Also: TAVREdwards 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 | Device | – |
Primary outcome
All cause mortality
Time frame: 30 days
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 16 Mar 2021.
- Derived from this study: PubMed 32580586Tarantini 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.
- Derived from this study: PubMed 31106841Fernandez-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.
- Derived from this study: PubMed 30630356Tarantini 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.
- Derived from this study: PubMed 30552511Frank 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.
- Derived from this study: PubMed 28605423Wendler 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.
- Individual participant dataSharing planned: No
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Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
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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.
Prof. Dr. Olaf Wendler, MD principal investigator
King's College Hospital NHS Trust
Prof. Dr. Alec Vahanian, MD principal investigator
Bichat Hospital
73 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Stenosis, run by Edwards Lifesciences at 73 sites in 10 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 3 inclusion and 3 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 16 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 73 sites in France, Germany, United Kingdom, Switzerland, Italy and 5 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?
All cause mortality (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 NCT02698956, which also lists 5 linked publications.
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 16 Mar 2021; AzTrials last refreshed its copy on 29 Oct 2026.