Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
Study NCT ID:
NCT04396418
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-20
First Post:
2020-05-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Stroke Prevention and Rhythm Control Therapy STEEER-AF
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1732}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-12-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-18', 'studyFirstSubmitDate': '2020-05-14', 'studyFirstSubmitQcDate': '2020-05-18', 'lastUpdatePostDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Process outcome', 'timeFrame': '25 months per centre', 'description': 'Improvement in knowledge and guideline-adherent practice by healthcare professionals using the educational intervention'}], 'primaryOutcomes': [{'measure': 'Adherence to ESC Guidelines in Atrial Filbrillation', 'timeFrame': '25 months per centre', 'description': 'Full adherence to guidelines for stroke prevention rhythm control therapy'}], 'secondaryOutcomes': [{'measure': 'Proportion of relevant guidelines adhered to', 'timeFrame': '25 months per centre', 'description': 'Proportion of relevant guidelines adhered to for stroke prevention and rhythm control'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Atrial fibrillation', 'Guideline adherence', 'stroke prevention', 'rhythm control', 'trial'], 'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '40514462', 'type': 'DERIVED', 'citation': 'Kotecha D, Bunting KV, Mehta S, Sommer P, Sterlinski M, Rajappan K, Mont L, Guasch E, Boveda S, Boriani G, Sun Y, van Deutekom C, Gale CP, De Potter TJR, van Gelder IC; STEEER-AF investigators. Education of healthcare professionals to improve guideline adherence in atrial fibrillation: the STEEER-AF cluster-randomized clinical trial. Nat Med. 2025 Aug;31(8):2647-2654. doi: 10.1038/s41591-025-03751-2. Epub 2025 Jun 13.'}, {'pmid': '38940494', 'type': 'DERIVED', 'citation': 'Sterlinski M, Bunting KV, Boriani G, Boveda S, Guasch E, Mont L, Rajappan K, Sommer P, Mehta S, Sun Y, Gale CP, van Deutekom C, Van Gelder IC, Kotecha D; STEEER-AF Trial Team. Design and deployment of the STEEER-AF trial to evaluate and improve guideline adherence: a cluster-randomized trial by the European Society of Cardiology and European Heart Rhythm Association. Europace. 2024 Jul 2;26(7):euae178. doi: 10.1093/europace/euae178.'}, {'pmid': '36746430', 'type': 'DERIVED', 'citation': "Szymanski P, Weidinger F, Lordereau-Richard I, Himmelmann A, Arca M, Chaves J, Lee C, Jonker C, Kotecha D, O'Kelly J, Plueschke K, Rys A, Segec A, Wallentin L, Veltrop R, James S. Real world evidence: Perspectives from a European Society of Cardiology Cardiovascular Round Table with contribution from the European Medicines Agency. Eur Heart J Qual Care Clin Outcomes. 2023 Feb 28;9(2):109-118. doi: 10.1093/ehjqcco/qcad009."}, {'pmid': '34969173', 'type': 'DERIVED', 'citation': 'Banerjee A, Pasea L, Chung SC, Direk K, Asselbergs FW, Grobbee DE, Kotecha D, Anker SD, Dyszynski T, Tyl B, Denaxas S, Lumbers RT, Hemingway H. A population-based study of 92 clinically recognized risk factors for heart failure: co-occurrence, prognosis and preventive potential. Eur J Heart Fail. 2022 Mar;24(3):466-480. doi: 10.1002/ejhf.2417. Epub 2022 Jan 26.'}]}, 'descriptionModule': {'briefSummary': 'A prospective trial with hospitals/health centres across 6 different European countries, being randomised to either a structured education programme as the intervention or no additional education as the control. To determine whether a comprehensive educational programme for healthcare professionals will increase the rate of appropriate stroke prevention and rhythm control therapy in patients with atrial fibrillation (AF) and adherence to Guidelines.', 'detailedDescription': 'Prospective, parallel group, two-arm, unblinded, international, cluster-randomized controlled trial.\n\nIntervention arm: A 16-week blended learning programme targeting stroke prevention and rhythm control therapy at the healthcare professional level, with controlled assessments, a commitment to change plan, and reinforcement actions Control arm: No added education of healthcare professionals 70 centres with a cluster size of 25 patients; total estimated number of patients 1750.\n\n8-12 weeks patient recruitment period at each centre; 16 weeks educational intervention period; primary \\& secondary outcomes at 6-9 months post-randomisation; remote follow-up for clinical events (no new patient contact) at 18 months from randomisation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with AF\n* Patient consents to data collection at baseline and follow-up.\n\nExclusion Criteria (patients only):\n\n* Patients aged under 18 years of age,\n* Pregnant or planning pregnancy,\n* Participating in another clinical trial of an investigational medicinal product or device,\n* Life expectancy of less than 2 years.\n\nPatient assessment: Baseline (time of recruitment) and at follow-up routine appointment (6-9 months), plus remote follow-up at 18 months.'}, 'identificationModule': {'nctId': 'NCT04396418', 'acronym': 'STEEER-AF', 'briefTitle': 'Stroke Prevention and Rhythm Control Therapy STEEER-AF', 'organization': {'class': 'NETWORK', 'fullName': 'European Society of Cardiology'}, 'officialTitle': 'Stroke Prevention and Rhythm Control Therapy: Evaluation of an Educational Programme of the European Society of Cardiology in a Cluster-Randomised Trial in Patients With Atrial Fibrillation', 'orgStudyIdInfo': {'id': 'STEEER-AF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention arm', 'description': 'A 16-week blended learning programme targeting stroke prevention and rhythm control therapy at the healthcare professional level, with controlled assessments, a commitment to change plan, and reinforcement actions', 'interventionNames': ['Behavioral: Education']}, {'type': 'OTHER', 'label': 'Control arm', 'description': 'No added education of healthcare professionals', 'interventionNames': ['Behavioral: Education']}], 'interventions': [{'name': 'Education', 'type': 'BEHAVIORAL', 'description': 'Randomization between two groups at site level. One cluster with education and one without.', 'armGroupLabels': ['Control arm', 'Intervention arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35000', 'city': 'Rennes', 'state': "'Ille-et-Vilaine, Brittany", 'country': 'France', 'facility': 'CHU Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '13005', 'city': 'Marseille', 'state': 'Bouches-du-Rhône', 'country': 'France', 'facility': 'CHU La Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '21000', 'city': 'Dijon', 'state': 'Burgundy', 'country': 'France', 'facility': 'CHU Dijon - Hôpital du Bocage', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '33600', 'city': 'Pessac', 'state': 'Gironde, Nouvelle-Aquitaine', 'country': 'France', 'facility': 'Hôpital Cardiologique du Haut-Lévèque', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'zip': '87000', 'city': 'Limoges', 'state': 'Haute-Vienne', 'country': 'France', 'facility': 'CHU Dupuytren', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '54500', 'city': 'Nancy', 'state': 'Meurthe-et-Moselle (Lorraine)', 'country': 'France', 'facility': 'CHU Nancy, Hôpitaux de Brabois', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'zip': '76000', 'city': 'Rouen', 'state': 'Normandy', 'country': 'France', 'facility': 'CHU Rouen', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '31400', 'city': 'Toulouse', 'state': 'Occitanie, Haute-Garonne', 'country': 'France', 'facility': 'CHU Rangueil', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '86000', 'city': 'Poitiers', 'state': 'Poitou-Charentes', 'country': 'France', 'facility': 'CHU Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '13100', 'city': 'Aix-en-Provence', 'state': "Provence-Alpes-Côte d'Azur Region", 'country': 'France', 'facility': 'CHU Aix en Provence', 'geoPoint': {'lat': 43.5283, 'lon': 5.44973}}, {'zip': '64046', 'city': 'Pau', 'state': 'Pyrénées-Atlantiques', 'country': 'France', 'facility': 'Centre Hospitalier de Pau', 'geoPoint': {'lat': 43.31117, 'lon': -0.35583}}, {'zip': '83100', 'city': 'Toulon', 'state': 'Var', 'country': 'France', 'facility': 'CHI Toulon La Seyne-sur-Mer Sainte Musse', 'geoPoint': {'lat': 43.12442, 'lon': 5.92836}}, {'zip': '94000', 'city': 'Créteil', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'Hôpital Henri Mondor (APHP)', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '75013', 'city': 'Paris', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'CHU Pitié-Salpetrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '93200', 'city': 'Saint-Denis', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'Centre Cardiologique du Nord (CCN)', 'geoPoint': {'lat': 48.93564, 'lon': 2.35387}}, {'zip': '97080', 'city': 'Würzburg', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'University Hospital Würzburg', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}, {'zip': '23795', 'city': 'Bad Segeberg', 'state': 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Wycombe Hospital', 'geoPoint': {'lat': 51.99968, 'lon': -0.98779}}, {'zip': 'NR1-NR16', 'city': 'Norwich', 'state': 'East of England', 'country': 'United Kingdom', 'facility': 'Norwich Hospital', 'geoPoint': {'lat': 52.62783, 'lon': 1.29834}}, {'zip': 'GL1 3NN', 'city': 'Gloucester', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Gloucestershire Royal Hospital', 'geoPoint': {'lat': 51.86568, 'lon': -2.2431}}, {'zip': 'E9 6SR', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Homerton Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'EC1A 7BE', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': "St Bartholomew's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SW10 9NH', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Imperial College London Chelsea and Westminster Hospital NHS foundation', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'TS4 3BW', 'city': 'Middlesbrough', 'state': 'England', 'country': 'United Kingdom', 'facility': 'James Cook University Hospital', 'geoPoint': {'lat': 54.57623, 'lon': -1.23483}}, {'zip': 'NN1 5BD', 'city': 'Northampton', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Northampton General Hospital', 'geoPoint': {'lat': 52.25, 'lon': -0.88333}}, {'zip': 'RG1 5AN', 'city': 'Reading', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Royal Berkshire foundation NHS trust', 'geoPoint': {'lat': 51.45625, 'lon': -0.97113}}, {'zip': 'YO31 8H', 'city': 'York', 'state': 'North Yorkshire', 'country': 'United Kingdom', 'facility': 'York Hospital', 'geoPoint': {'lat': 53.95763, 'lon': -1.08271}}, {'zip': 'OX16', 'city': 'Banbury', 'state': 'River Cherwell in Oxfordshire', 'country': 'United Kingdom', 'facility': 'Horton General Hospital', 'geoPoint': {'lat': 52.0632, 'lon': -1.34222}}, {'zip': '01392', 'city': 'Exeter', 'state': 'West England', 'country': 'United Kingdom', 'facility': 'Royal Devon and Exeter NHS Foundation Trust', 'geoPoint': {'lat': 50.7236, 'lon': -3.52751}}, {'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'Queen Elizabeth II', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}], 'overallOfficials': [{'name': 'Hein Heidbuchel', 'role': 'STUDY_CHAIR', 'affiliation': 'Universiteit Antwerpen'}, {'name': 'Dipak Kotecha', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Birmingham'}, {'name': 'Isabelle van Gelder', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Medical Center Groningen, The Netherlands'}, {'name': 'Serge Boveda', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinique Pasteur, France'}, {'name': 'Philipp Sommer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ruhr-Universität Bochum, Germany'}, {'name': 'Giuseppe Boriani', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Modena & Reggio Emilia'}, {'name': 'Maciej Sterliński', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Institute of Cardiology, Warsaw, Poland'}, {'name': 'Luis Mont', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Barcelona, Spain'}, {'name': 'Kim Rajappan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oxford, UK'}, {'name': 'Eduard Guasch', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Barcelona, Spain'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Society of Cardiology', 'class': 'NETWORK'}, 'collaborators': [{'name': 'University of Birmingham', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}