Ignite Creation Date:
2025-12-24 @ 3:58 PM
Ignite Modification Date:
2025-12-29 @ 7:00 PM
Study NCT ID:
NCT01108692
Status:
COMPLETED
Last Update Posted:
2013-12-06
First Post:
2010-04-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Strategy of Early Detection and Active Management of Supraventricular Arrhythmia With Telecardiology (SETAM)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D001282', 'term': 'Atrial Flutter'}], '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': 'D015190', 'term': 'Blood Glucose Self-Monitoring'}, {'id': 'D000098465', 'term': 'Remote Patient Monitoring'}], 'ancestors': [{'id': 'D001774', 'term': 'Blood Chemical Analysis'}, {'id': 'D019963', 'term': 'Clinical Chemistry Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003940', 'term': 'Diagnostic Techniques, Endocrine'}, {'id': 'D008991', 'term': 'Monitoring, Physiologic'}, {'id': 'D000085263', 'term': 'Self-Testing'}, {'id': 'D012648', 'term': 'Self Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017216', 'term': 'Telemedicine'}, {'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 602}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-05', 'studyFirstSubmitDate': '2010-04-21', 'studyFirstSubmitQcDate': '2010-04-21', 'lastUpdatePostDateStruct': {'date': '2013-12-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Delay to implement antithrombotic and/or antiarrhythmic drugs for the supraventricular arrhythmia.', 'timeFrame': '12-month', 'description': 'Delay from enrollment until the next in-office follow-up during which the supraventricular arrhythmia is managed for the first-time.'}], 'secondaryOutcomes': [{'measure': 'Serious adverse events related to supraventricular arrhythmia.', 'timeFrame': '12-month', 'description': 'Including : Stroke, systemic embolic event, death, bleeding, and hospitalization for cardiac insufficiency'}, {'measure': 'Atrial burden at the end of the study', 'timeFrame': '12-month'}, {'measure': 'Atrial burden related to time', 'timeFrame': '12-month', 'description': 'In order to check if atrial burden is time-dependent.'}, {'measure': 'Supraventricular arrhythmia prevalence', 'timeFrame': '12-month', 'description': 'Proportion of patients with supraventricular arrhythmia at the end of the 12-month follow-up.'}, {'measure': 'Number of patients with managed supraventricular arrhythmia', 'timeFrame': '12-month', 'description': 'Number of patients with supraventricular arrhythmia and for whom the physician implemented an overall management strategy (antithrombotic and/or antiarrhythmic drugs).'}, {'measure': 'Supraventricular arrhythmia symptoms score (via a questionnaire)', 'timeFrame': 'at each follow-up visit', 'description': 'Questionnaire submitted to the patient at enrollment and at each follow-up visit.'}, {'measure': 'Quality of Life (via the EQ-5D Questionnaire)', 'timeFrame': 'at each follow-up visit', 'description': "The general health perception of the patients will be asked for, via the standardized EuroQOL EQ-5D questionnaire. This questionnaire provides a descriptive profile covering five dimensions (mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression) as well as a self-rating score of the patient's own assessment of its heath status."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['atrial fibrillation', 'supraventricular arrhythmia', 'antithrombotic treatment', 'antiarrhythmic drugs', 'medical reaction time', 'telecardiology', 'early detection', 'holters memories', 'Pacemaker'], 'conditions': ['Atrial Fibrillation', 'Atrial Flutter', 'Atrial Tachycardia']}, 'descriptionModule': {'briefSummary': 'This study investigates if the early detection and treatment of supraventricular arrhythmia (SVA) may help to prevent the progression of the arrhythmia and improve the clinical outcome.\n\nThe primary endpoint investigates the delay to implement treatment in two groups of patients :\n\n* Active group: Patients followed by telecardiology.\n* Control group: Patients followed in the conventional manner.\n\nIt is assumed that the delay to implement treatment will be higher in the Control group.', 'detailedDescription': 'Atrial fibrillation is the most commonly encountered sustained cardiac arrhythmia in medical practice and it is often associated with atrial flutter. In patients with the new pacemaker generation EVIA, the home-monitoring technology provides specific and clinical relevant notifications for detection of atrial arrhythmias. Combined with holters memories, this can help to optimize the treatment of supraventricular arrhythmia (SVA) such as atrial fibrillation or flutter.\n\nThis study will compare in the two groups the delay to implement for the first time a treatment for the supraventricular arrhythmia (antiarrhythmic drugs and/or an antithrombotic treatment).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Dual chamber pacemaker with activated Telecardiology\n* CHAD2DS2-VASc score ≥ 2\n* Sinusal rhythm at enrollment\n* Patient willing and able to comply with the protocol\n* Patient has provided informed consent\n* Men and women \\> 18 years-old\n* Patients geographically stable\n\nExclusion Criteria:\n\n* Anticoagulation therapy\n* Dual anti-platelet therapy\n* Class I or class III anti-arrhythmic drugs\n* Contraindication to antithrombotic therapy\n* Participation in another clinical study\n* Have a life expectancy \\< 6 months'}, 'identificationModule': {'nctId': 'NCT01108692', 'acronym': 'SETAM', 'briefTitle': 'Strategy of Early Detection and Active Management of Supraventricular Arrhythmia With Telecardiology (SETAM)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biotronik France'}, 'officialTitle': 'Investigation on Early Detection and Active Management of Supra-ventricular Arrhythmia With Telecardiology', 'orgStudyIdInfo': {'id': 'HS053'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active', 'description': 'Patients will be followed by telecardiology.', 'interventionNames': ['Other: Telecardiology']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Patients will be followed in the conventional manner. They will be equipped with telecardiology but data will not be used for patient surveillance.', 'interventionNames': ['Other: Telecardiology']}], 'interventions': [{'name': 'Telecardiology', 'type': 'OTHER', 'otherNames': ['Home-Monitoring', 'Remote monitoring'], 'description': 'Telecardiology will be switched on for both groups. For the Active group, all data will be transmitted to the physician. For the Control group, data will not be used for patients surveillance, only events regarding implant (Elective Replacement Indication) or events regarding data transmission missing will be generated and sent to the physician.\n\nA retrospective analysis will be performed at the end of the study to compare the results in the two groups.', 'armGroupLabels': ['Active', 'Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Abbeville', 'country': 'France', 'facility': "CH Général d'Abbeville", 'geoPoint': {'lat': 50.10521, 'lon': 1.83547}}, {'city': 'Aix-en-Provence', 'country': 'France', 'facility': "CH du Pays d'Aix", 'geoPoint': {'lat': 43.5283, 'lon': 5.44973}}, {'city': 'Annecy', 'country': 'France', 'facility': "CH de la région d'Annecy", 'geoPoint': {'lat': 45.90878, 'lon': 6.12565}}, {'city': 'Argenteuil', 'country': 'France', 'facility': "CH d'Argentueil", 'geoPoint': {'lat': 48.94788, 'lon': 2.24744}}, {'city': 'Arras', 'country': 'France', 'facility': "CH d'ARRAS", 'geoPoint': {'lat': 50.29301, 'lon': 2.78186}}, {'city': 'Aurillac', 'country': 'France', 'facility': "CH d'AURILLAC", 'geoPoint': {'lat': 44.92539, 'lon': 2.43983}}, {'city': 'Auxerre', 'country': 'France', 'facility': "CH d'AUXERRE", 'geoPoint': {'lat': 47.7996, 'lon': 3.57033}}, {'city': 'Avignon', 'country': 'France', 'facility': "CH d'AVIGNON", 'geoPoint': {'lat': 43.94834, 'lon': 4.80892}}, {'city': 'Béziers', 'country': 'France', 'facility': 'CH de Béziers', 'geoPoint': {'lat': 43.34122, 'lon': 3.21402}}, {'city': 'Blois', 'country': 'France', 'facility': 'CH de Blois', 'geoPoint': {'lat': 47.59432, 'lon': 1.32912}}, {'zip': '18016', 'city': 'Bourges', 'country': 'France', 'facility': 'Centre Hospitalier Jacques Coeur', 'geoPoint': {'lat': 47.08333, 'lon': 2.4}}, {'city': 'Bry-sur-Marne', 'country': 'France', 'facility': 'Hôpital Sainte Camille', 'geoPoint': {'lat': 48.83811, 'lon': 2.52488}}, {'city': 'Cannes', 'country': 'France', 'facility': 'CH de Cannes', 'geoPoint': {'lat': 43.55135, 'lon': 7.01275}}, {'city': 'Castres', 'country': 'France', 'facility': 'CH de Castres', 'geoPoint': {'lat': 43.60527, 'lon': 2.24088}}, {'city': 'Chalon-sur-Saône', 'country': 'France', 'facility': 'CH William Morey', 'geoPoint': {'lat': 46.78112, 'lon': 4.85372}}, {'city': 'Chartres', 'country': 'France', 'facility': 'Les Hôpitaux de Chartres', 'geoPoint': {'lat': 48.44685, 'lon': 1.48925}}, {'city': 'Châteauroux', 'country': 'France', 'facility': 'CH de CHATEAUROUX', 'geoPoint': {'lat': 46.81248, 'lon': 1.69362}}, {'city': 'Cherbourg', 'country': 'France', 'facility': 'CH Public du Cotentin', 'geoPoint': {'lat': 49.63984, 'lon': -1.61636}}, {'city': 'Clamart', 'country': 'France', 'facility': 'HIA Percy', 'geoPoint': {'lat': 48.80299, 'lon': 2.26692}}, {'city': 'Colmar', 'country': 'France', 'facility': 'CHG Louis Pasteur', 'geoPoint': {'lat': 48.08078, 'lon': 7.35584}}, {'city': 'Colmar', 'country': 'France', 'facility': 'Hôpital Schweitzer', 'geoPoint': {'lat': 48.08078, 'lon': 7.35584}}, {'city': 'Dinan', 'country': 'France', 'facility': 'CH DINAN', 'geoPoint': {'lat': 48.45553, 'lon': -2.05049}}, {'city': 'Dole', 'country': 'France', 'facility': 'CH de DOLE', 'geoPoint': {'lat': 47.09225, 'lon': 5.48966}}, {'city': 'Douarnenez', 'country': 'France', 'facility': 'CH de DOUARNENEZ', 'geoPoint': {'lat': 48.09542, 'lon': -4.32904}}, {'city': 'Évreux', 'country': 'France', 'facility': 'CHI Eure-Seine', 'geoPoint': {'lat': 49.02414, 'lon': 1.15082}}, {'city': 'Firminy', 'country': 'France', 'facility': 'CH de Firminy', 'geoPoint': {'lat': 45.38956, 'lon': 4.2886}}, {'city': 'Haguenau', 'country': 'France', 'facility': "CH d'HAGUENAU", 'geoPoint': {'lat': 48.81557, 'lon': 7.79051}}, {'city': 'Jonzac', 'country': 'France', 'facility': 'CH de Jonzac', 'geoPoint': {'lat': 45.44636, 'lon': -0.43485}}, {'zip': '85925', 'city': 'La Roche-sur-Yon', 'country': 'France', 'facility': 'Centre Hospitalier Départemental Les Oudairies', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}, {'city': 'La Rochelle', 'country': 'France', 'facility': 'CH Saint Louis', 'geoPoint': {'lat': 46.16308, 'lon': -1.15222}}, {'city': 'Lagny-sur-Marne', 'country': 'France', 'facility': 'CH de Lagny', 'geoPoint': {'lat': 48.86667, 'lon': 2.71667}}, {'city': 'Laval', 'country': 'France', 'facility': 'CH de LAVAL', 'geoPoint': {'lat': 48.07247, 'lon': -0.77019}}, {'city': 'Le Chesnay', 'country': 'France', 'facility': 'CH A.Mignot', 'geoPoint': {'lat': 48.8222, 'lon': 2.12213}}, {'city': 'Le Mans', 'country': 'France', 'facility': 'CH du Mans', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}, {'city': 'Lens', 'country': 'France', 'facility': 'CH de Lens', 'geoPoint': {'lat': 50.43302, 'lon': 2.82791}}, {'city': 'Lomme', 'country': 'France', 'facility': "Groupe Hospitalier de l'Institut catholique de Lille", 'geoPoint': {'lat': 50.64358, 'lon': 2.98715}}, {'city': 'Longjumeau', 'country': 'France', 'facility': 'CH de Longjumeau', 'geoPoint': {'lat': 48.69307, 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'CH de TROYES', 'geoPoint': {'lat': 48.30073, 'lon': 4.08524}}, {'city': 'Valence', 'country': 'France', 'facility': 'CH de Valence', 'geoPoint': {'lat': 44.9256, 'lon': 4.90956}}, {'city': 'Valenciennes', 'country': 'France', 'facility': 'CH de Valenciennes', 'geoPoint': {'lat': 50.35909, 'lon': 3.52506}}, {'city': 'Vannes', 'country': 'France', 'facility': 'CH Bretagne Atlantique', 'geoPoint': {'lat': 47.65688, 'lon': -2.76205}}, {'city': 'Villeneuve-Saint-Georges', 'country': 'France', 'facility': 'CHI de Villeneuve', 'geoPoint': {'lat': 48.73219, 'lon': 2.44925}}], 'overallOfficials': [{'name': 'Walid AMARA, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Intercommunal General Hospital in Montfermeil (93370 MONTFERMEIL- FRANCE)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biotronik France', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Biotronik SE & Co. KG', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}