Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-04-16 @ 4:47 PM
Study NCT ID:
NCT02698956
Status:
COMPLETED
Last Update Posted:
2021-03-16
First Post:
2015-02-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SOURCE 3: Observational Study to Evaluate Safety and Performance of SAPIEN 3 THV System in Real Life Practice
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065467', 'term': 'Transcatheter Aortic Valve Replacement'}], 'ancestors': [{'id': 'D019918', 'term': 'Heart Valve Prosthesis Implantation'}, {'id': 'D006348', 'term': 'Cardiac Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-12', 'studyFirstSubmitDate': '2015-02-27', 'studyFirstSubmitQcDate': '2016-02-29', 'lastUpdatePostDateStruct': {'date': '2021-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All cause mortality', 'timeFrame': '30 days'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['SAPIEN 3 THV', 'TAVI', 'Transfemoral', 'Transaortic', 'Transapical', 'Aortic valve'], 'conditions': ['Aortic Stenosis']}, 'referencesModule': {'references': [{'pmid': '32580586', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '31106841', 'type': 'DERIVED', 'citation': 'Fernandez-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.'}, {'pmid': '30630356', 'type': 'DERIVED', 'citation': 'Tarantini 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.'}, {'pmid': '30552511', 'type': 'DERIVED', 'citation': 'Frank 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.'}, {'pmid': '28605423', 'type': 'DERIVED', 'citation': 'Wendler 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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\n300 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.', 'detailedDescription': '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.\n\nConsecutive 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients suffering from severe aortic stenosis. Inclusion criteria are based on the decision of the Heart Team.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient suffering from severe, symptomatic, calcific aortic stenosis\n* STS Score ≥ 8\n* Logistic EuroSCORE ≥15\n\nExclusion Criteria:\n\n* Congenital unicuspid or congenital bicuspid aortic valve\n* Evidence of intracardiac mass, thrombus or vegetation\n* Active infection or endocarditis'}, 'identificationModule': {'nctId': 'NCT02698956', 'acronym': 'SOURCE 3', 'briefTitle': 'SOURCE 3: Observational Study to Evaluate Safety and Performance of SAPIEN 3 THV System in Real Life Practice', 'organization': {'class': 'INDUSTRY', 'fullName': 'Edwards Lifesciences'}, 'officialTitle': 'Edwards SAPIEN 3 Aortic Bioprosthesis Multi-Region Outcome Registry', 'orgStudyIdInfo': {'id': '2014-01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'TAVI (Transcatheter Aortic Valve Implantation)', 'type': 'DEVICE', 'otherNames': ['TAVR'], 'description': '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'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Aarhus University Hospital, Skejby', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': '00100', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'Helsinki University Hospital', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': '90029 OYS', 'city': 'Oulu', 'country': 'Finland', 'facility': 'Oulu University Hospital', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}, {'zip': '49100', 'city': 'Angers', 'country': 'France', 'facility': 'CHU Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '25000', 'city': 'Besançon', 'country': 'France', 'facility': 'Hopital Jean Minjoz - Besancon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '33000', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Clinique Saint-Augustin - Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '29609', 'city': 'Brest', 'country': 'France', 'facility': 'CHU La Cavalle Blanche - Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '63000', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU Gabriel-Montpied - Clermont Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '21079', 'city': 'Dijon', 'country': 'France', 'facility': 'CHU Bocage - Dijon', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '38700', 'city': 'Grenoble', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '78150', 'city': 'Le Chesnay', 'country': 'France', 'facility': 'Hopital Prive Parly II - Le Chesnay', 'geoPoint': {'lat': 48.8222, 'lon': 2.12213}}, {'zip': '92350', 'city': 'Le Plessis-Robinson', 'country': 'France', 'facility': 'Centre Chirurgical Marie Lannelongue - Le Plessis-Robinson', 'geoPoint': {'lat': 48.78889, 'lon': 2.27078}}, {'zip': '59000', 'city': 'Lille', 'country': 'France', 'facility': 'CHRU Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '59000', 'city': 'Lille', 'country': 'France', 'facility': 'Polyclinique Bois - Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '69002', 'city': 'Lyon', 'country': 'France', 'facility': 'Hospices Civiles de Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '69002', 'city': 'Lyon', 'country': 'France', 'facility': 'Hospices Civils de Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '13005', 'city': 'Marseille', 'country': 'France', 'facility': 'CHU La Timone - Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '13009', 'city': 'Marseille', 'country': 'France', 'facility': 'Clinique Clairval - Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '13285', 'city': 'Marseille', 'country': 'France', 'facility': 'Hopital Saint Joseph - Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '91300', 'city': 'Massy', 'country': 'France', 'facility': 'Institut Hospitalier Jacques Cartier Massy', 'geoPoint': {'lat': 48.72692, 'lon': 2.28301}}, {'zip': '54000', 'city': 'Nancy', 'country': 'France', 'facility': 'C.H.U. de Nancy', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'zip': '92200', 'city': 'Neuilly-sur-Seine', 'country': 'France', 'facility': 'Clinique Ambroise Pare - Neuilly', 'geoPoint': {'lat': 48.8846, 'lon': 2.26965}}, {'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'CH Pitie Salpetriere', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'Institut Mutualiste Montsouris - Paris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75018', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Bichat Paris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '76000', 'city': 'Rouen', 'country': 'France', 'facility': 'CHU Hopital Charles Nicolle Rouen', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '93200', 'city': 'Saint-Denis', 'country': 'France', 'facility': 'Centre Cardiologique du Nord - Saint-Denis', 'geoPoint': {'lat': 48.93564, 'lon': 2.35387}}, {'zip': '44800', 'city': 'Saint-Herblain', 'country': 'France', 'facility': 'CHU Nantes-Laennec', 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}, {'zip': '67000', 'city': 'Strasbourg', 'country': 'France', 'facility': 'CHRU Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'CHU Rangueil Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '37000', 'city': 'Tours', 'country': 'France', 'facility': 'Clinique Saint-Gatien - Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'zip': '86156', 'city': 'Augsburg', 'country': 'Germany', 'facility': 'Klinikum Augsburg', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}, {'zip': '99438', 'city': 'Bad Berka', 'country': 'Germany', 'facility': 'Zentralklinik Bad Berka GmbH', 'geoPoint': {'lat': 50.89982, 'lon': 11.28245}}, {'zip': '79189', 'city': 'Bad Krozingen', 'country': 'Germany', 'facility': 'Herz-Zentrum Bad Krozingen', 'geoPoint': {'lat': 47.91667, 'lon': 7.7}}, {'zip': '61231', 'city': 'Bad Nauheim', 'country': 'Germany', 'facility': 'Kerckhoff-Klinik GmbH Bad Nauheim', 'geoPoint': {'lat': 50.36463, 'lon': 8.73859}}, {'zip': '97616', 'city': 'Bad Neustadt an der Saale', 'country': 'Germany', 'facility': 'Herz und Gefaess Klinik - Bad Neustadt', 'geoPoint': {'lat': 50.32174, 'lon': 10.20673}}, {'zip': '32545', 'city': 'Bad Oeynhausen', 'country': 'Germany', 'facility': 'Herz- und Diabeteszentrum NRW - Bad Oeynhausen', 'geoPoint': {'lat': 52.20699, 'lon': 8.80365}}, {'zip': '49214', 'city': 'Bad Rothenfelde', 'country': 'Germany', 'facility': 'Schuechtermann Klinik Bad Rothenfelde', 'geoPoint': {'lat': 52.11667, 'lon': 8.16667}}, {'zip': '23795', 'city': 'Bad Segeberg', 'country': 'Germany', 'facility': 'Herzzentrum Bad Segeberg', 'geoPoint': {'lat': 53.93775, 'lon': 10.30745}}, {'zip': '16321', 'city': 'Bernau', 'country': 'Germany', 'facility': 'Immanuel Klinikum Bernau Herzzentrum Brandenburg', 'geoPoint': {'lat': 47.80018, 'lon': 8.0383}}, {'zip': '50937', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Uniklinik Koeln - Herzzentrum', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '47137', 'city': 'Duisburg', 'country': 'Germany', 'facility': 'Evangelisches Klinikum Niederrhein Herzzentrum Duisburg', 'geoPoint': {'lat': 51.43247, 'lon': 6.76516}}, {'zip': '91054', 'city': 'Erlangen', 'country': 'Germany', 'facility': 'Universitaetsklinik Erlangen', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'zip': '20099', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Asklepios Klinik St Georg Hamburg', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '20251', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Universitares Herzzentrum Hamburg', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '17495', 'city': 'Karlsburg', 'country': 'Germany', 'facility': 'Klinikum Karlsburg der Klinikgruppe Dr. Guth GmbH & Co. KG', 'geoPoint': {'lat': 53.97172, 'lon': 13.61007}}, {'zip': '76133', 'city': 'Karlsruhe', 'country': 'Germany', 'facility': 'Staedtisches Klinikum Karlsruhe GmbH (SKK)', 'geoPoint': {'lat': 49.00937, 'lon': 8.40444}}, {'zip': '24105', 'city': 'Kiel', 'country': 'Germany', 'facility': 'Universitaetsklinikum Schleswig Holstein Campus Kiel', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'zip': '4289', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Herzzentrum Leipzig GmbH', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '67063', 'city': 'Ludwigshafen', 'country': 'Germany', 'facility': 'Klinikum der Stadt Ludwigshafen am Rhein gGmbH', 'geoPoint': {'lat': 47.81663, 'lon': 9.06138}}, {'zip': '55131', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Johannes Gutenberg Universitaet Mainz', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '80636', 'city': 'München', 'country': 'Germany', 'facility': 'Deutsches Herzzentrum Muenchen (DHM)', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '48149', 'city': 'Münster', 'country': 'Germany', 'facility': 'Universitaetsklinikum Muenster', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': '93053', 'city': 'Regensburg', 'country': 'Germany', 'facility': 'Universitaetsklinikum Regensburg', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}, {'zip': '53721', 'city': 'Siegburg', 'country': 'Germany', 'facility': 'Helios Klinikum Siegburg', 'geoPoint': {'lat': 50.80019, 'lon': 7.20769}}, {'zip': '70376', 'city': 'Stuttgart', 'country': 'Germany', 'facility': 'Robert-Bosch Hospital Stuttgart', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}, {'zip': '89081', 'city': 'Ulm', 'country': 'Germany', 'facility': 'Universitaetsklinikum Ulm', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}, {'zip': '20132', 'city': 'Milan', 'country': 'Italy', 'facility': 'Ospedale San Raffaele Milano', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '20138', 'city': 'Milan', 'country': 'Italy', 'facility': 'Centro Cardiologico Monzino Milano', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '90127', 'city': 'Palermo', 'country': 'Italy', 'facility': 'Azienda A.R.N.A.S. Ospedale Civico di Palermo', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'zip': '3584 CX', 'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'Universitair Medisch Centrum Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'zip': '83348', 'city': 'Bratislava', 'country': 'Slovakia', 'facility': 'Narodny ustav srdcovych a cievnych chorob, a. s.', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}, {'zip': '20014', 'city': 'San Sebastián', 'country': 'Spain', 'facility': 'Policlinica Gipuzkoa Hospital', 'geoPoint': {'lat': 43.56667, 'lon': -5.9}}, {'zip': '4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'Universitaetsspital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'Inselspital Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'zip': '8027', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Klinik im Park Zuerich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'zip': '8032', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'HerzKlinik Hirslanden HKH - Zuerich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'zip': 'B15 2TH', 'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'Queen Elisabeth Hospital Birmingham', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'CB23 3RE', 'city': 'Cambridge', 'country': 'United Kingdom', 'facility': 'Papworth Hospital NHS Foundation Trust', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'EH16 4SA', 'city': 'Edinburgh', 'country': 'United Kingdom', 'facility': 'Royal Infirmary of Edinburgh', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}, {'zip': 'SE17EH', 'city': 'London', 'country': 'United Kingdom', 'facility': 'St. Thomas Hospital London', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SE5 9RS', 'city': 'London', 'country': 'United Kingdom', 'facility': 'King´s College Hospital London', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'PL6 8DH', 'city': 'Plymouth', 'country': 'United Kingdom', 'facility': 'Derriford Hospital Plymouth', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}], 'overallOfficials': [{'name': 'Prof. Dr. Olaf Wendler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "King's College Hospital NHS Trust"}, {'name': 'Prof. Dr. Alec Vahanian, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hopital Bichat, Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Edwards Lifesciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}