Ignite Creation Date:
2025-12-26 @ 10:16 PM
Ignite Modification Date:
2026-03-06 @ 5:56 PM
Study NCT ID:
NCT01594112
Status:
COMPLETED
Last Update Posted:
2017-03-17
First Post:
2012-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ability of Home Monitoring® to Detect and Manage the Inappropriate Diagnoses in Implantable Cardioverter Defibrillators.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016757', 'term': 'Death, Sudden, Cardiac'}, {'id': 'D014693', 'term': 'Ventricular Fibrillation'}, {'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D017180', 'term': 'Tachycardia, Ventricular'}, {'id': 'D012769', 'term': 'Shock'}], 'ancestors': [{'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003645', 'term': 'Death, Sudden'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D013610', 'term': 'Tachycardia'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 512}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2015-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-16', 'studyFirstSubmitDate': '2012-05-03', 'studyFirstSubmitQcDate': '2012-05-07', 'lastUpdatePostDateStruct': {'date': '2017-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-05-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relative proportion of patients experiencing at least one inappropriate therapy (retrospective part) or more than one inappropriate therapy (prospective part)', 'timeFrame': '15 months', 'description': 'Study of the relationship between the detection of ID, the corrective action taken and the recurrence of ID of the same mechanism.'}], 'secondaryOutcomes': [{'measure': 'Number of diagnoses per patient per year and relative proportion of patients with at least one diagnosis', 'timeFrame': '15 months', 'description': 'The number of diagnoses per patient per year and the associated proportion of patients (with at least one diagnosis) will be measured. This will give the incidence rate of experiencing special classes of diagnoses over the 15-months follow-up period. The following subclasses will be assessed:\n\nAppropriate or not diagnoses, ID without therapy, therapies defined as shocks or antitachycardia pacing (ATP), shocks, inappropriate shocks, recurrence of ID and recurrence of inappropriate shocks.\n\nThe prospective part will be compared to the retrospective part.'}, {'measure': 'Relative proportion of patients with a second day of ID', 'timeFrame': '15 months', 'description': 'Knowing that the intervals between ID days cannot be predetermined (non normal distribution), medical reaction time anticipated with Home Monitoring® can reduce the number of patients with a second day of ID.\n\nThe proportion of patients with more than one inappropriate diagnosis will be measured.'}, {'measure': 'Number of Asymptomatic Inappropriate therapy and Inappropriate therapy without diagnosis', 'timeFrame': '15 months', 'description': 'Knowing that the main added value of Home Monitoring® relates on asymptomatic inappropriate therapies and inappropriate diagnoses without therapy (IDWT), the number of asymptomatic IT or IDWT patient per year and the associated proportion of patients (with at least one inappropriate diagnosis) will be measured.'}, {'measure': 'Time to the first ID', 'timeFrame': '15 months', 'description': 'The time from the enrolment until the first EGM revealing the ID will be assessed.'}, {'measure': 'Medical reaction time to the ID', 'timeFrame': '15 months', 'description': 'The time from the first ID to the follow-up visit during which a corrective action is taken is defined as the medical reaction time and will be assessed.\n\nIn case of hospitalization without a follow-up visit (lead replacement for instance), the first day of hospitalization will be considered as the follow-up visit date.\n\nIn current practice, the patients receiving shocks are advised to call their physicians in order to have their ICD interrogated. The analysis will distinguish the symptomatic IT and the asymptomatic ID (asymptomatic IT or IDWT).'}, {'measure': 'Number of days of recurrence within the medical reaction time', 'timeFrame': '15 months', 'description': 'The number of days with at least one ID within the medical reaction time is defined as the number of days of recurrence and will be evaluated with the associated proportion of patients. The analysis will distinguish the symptomatic IT and the asymptomatic ID (asymptomatic IT or IDWT).'}, {'measure': 'Effectiveness of the corrective action and analysis according to the initial ID type', 'timeFrame': '15 months', 'description': 'The proportion of patients with at least one inappropriate diagnosis recurrence (first day of recurrence) after the corrective action, and with the same ID mechanism as the original one, will be evaluated.\n\nA subgroup analysis depending on the ID mechanism will be performed, considering the inhomogeneous efficiency of the corrective action depending on the initial mechanism of the inappropriate diagnosis/therapy .\n\nThe time from the follow-up visit during which the corrective action is taken until the next ID will be measured to assess the effectiveness of the corrective action.'}, {'measure': 'Classification of ID', 'timeFrame': '15 months', 'description': "The proportion of patient in the following classes of ID episodes will be evaluated:\n\n* Atrial fibrillation,\n* Other forms of supraventricular tachyarrhythmia\n* Sinus tachycardia\n* Abnormal sensing (T wave oversensing, interferences,…)\n* Other: the comparison is performed as an inter observer comparison between the Adjudication Board's and the physician's classification."}, {'measure': 'Total number of hospitalizations/deaths related to ID and IT', 'timeFrame': '15 months', 'description': 'Knowing that inappropriate therapies are among the heaviest ICD side-effects, the total number of hospitalizations and deaths related to ID or IT will be assessed.'}, {'measure': 'Risk of all-cause mortality', 'timeFrame': '15 months', 'description': 'The risk of death associated with inappropriate therapy only, with the inappropriate shocks only, with any shocks, without any therapy, without any shocks will be evaluated.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Remote monitoring', 'Home monitoring', 'Defibrillators, Implantable cardioverter-defibrillator', 'Shock', 'Inappropriate diagnoses and Therapies', 'Corrective actions', 'ID recurrences', 'Medical reaction time'], 'conditions': ['ICD', 'Sudden Cardiac Death', 'Ventricular Fibrillation', 'Atrial Fibrillation', 'Ventricular Tachycardia']}, 'referencesModule': {'references': [{'pmid': '30605510', 'type': 'DERIVED', 'citation': 'Perrin T, Boveda S, Defaye P, Rosier A, Sadoul N, Bordachar P, Klug D, Ritter P, Belhameche M, Babuty D, Mansourati J, Lazarus A, Deharo JC. Role of medical reaction in management of inappropriate ventricular arrhythmia diagnosis: the inappropriate Therapy and HOme monitoRiNg (THORN) registry. Europace. 2019 Apr 1;21(4):607-615. doi: 10.1093/europace/euy284.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the THORN registry is to show the ability of Home-Monitoring® to early identify and manage the inappropriate diagnoses of ventricular arrhythmia in ICD patients (i.e. lead rupture, atrial arrhythmia, oversensing…) whatever the type of device (single, dual, or triple chamber).\n\nThe electromyograms (iEGMs) provided by Remote Patient Monitoring will help the physician to early detect inadequate arrhythmia detection (ID) that can be responsible for inappropriate therapies (IT), and to take preventive actions in order to reduce the burden of these inappropriate therapies.\n\nTHORN is an observational epidemiologic, prospective and multicenter registry. The primary objective is to measure the relative proportion of patients experiencing at least one inappropriate therapy during a fifteen months follow-up period. Moreover, THORN will assess the incidence, predictors, outcome and recurrence of inappropriate diagnoses in 1750 ICD patients.', 'detailedDescription': "Remote Patient Monitoring allows early detection of events that can generate inadequate detection of ventricular arrhythmia (i.e. lead rupture, atrial arrhythmia, oversensing….) and be responsible for inappropriate therapies. In such cases, it may be assumed that physicians can react earlier and take preventive actions, in order to reduce the risk or burden of inappropriate therapies.\n\nThe THORN registry has two purposes:\n\n* To determine retrospectively the relative proportion of patients experiencing at least one inappropriate therapy during 15-months of follow-up, in ICD patients equipped with Home Monitoring®. This part concern 1240 patients.\n* To evaluate prospectively the relationship between the detection of inappropriate diagnosis (with or without subsequent inappropriate therapy), the corrective action taken, and the recurrences of inappropriate diagnosis of the same origin/mechanism. This part concerns 510 patients.\n\nBIOTRONIK Home Monitoring® by iEGM-Online® with Biotronik ICD devices (LUMAX) systematically stores any episode classified as ventricular tachycardia (VT) or ventricular fibrillation (VF) which is transmitted to the physician.\n\nIn the THORN study, in addition to the physicians' analysis, all electromyograms will be reviewed by an adjudication committee in order to classify them as appropriate or inappropriate diagnosis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Population implanted of ICD with Biotronik Home Monitoring® system. 512 patients will be selected by investigators in 50 centers in France.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject implanted with a single, dual, or triple chambers ICD within the last 3 months\n* Home Monitoring® activated and functional since hospital discharge\n* Patient willing and able to comply with the protocol and who has provided written informed consent about Home Monitoring®,\n* Patient whose medical situation is stable\n\nExclusion Criteria:\n\n* ICD replacements\n* New York Heart Association Function Class IV patients\n* Pregnant women or women who plan to become pregnant during the trial\n* Presence of any disease, other than patient's cardiac disease, associated with reduced likelihood of survival for the duration of the trial, e.g. cancer, uraemia (urea \\> 70mg/dl or creatinine \\>3mg/dl), liver failure, etc.\n* Age \\< 18 years\n* Patient unable to handle the Biotronik's transmitter correctly\n* Change of residence expected during the study\n* Insufficient global system for mobile communication (GSM) coverage at patient's home\n* Participation in another clinical study"}, 'identificationModule': {'nctId': 'NCT01594112', 'acronym': 'THORN', 'briefTitle': 'Ability of Home Monitoring® to Detect and Manage the Inappropriate Diagnoses in Implantable Cardioverter Defibrillators.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biotronik SE & Co. KG'}, 'officialTitle': 'Inappropriate Therapies and Home Monitoring® in Implantable Cardioverter Defibrillators (ICD)', 'orgStudyIdInfo': {'id': 'HS056'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient with at least one ID', 'description': 'Patient with ICD who received at least one inappropriate diagnosis (with or without therapy) during the 15 months follow-up.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '13100', 'city': 'Aix-en-Provence', 'country': 'France', 'facility': "CH d'Aix en Provence", 'geoPoint': {'lat': 43.5283, 'lon': 5.44973}}, {'zip': '49033', 'city': 'Angers', 'country': 'France', 'facility': "CH d'Angers", 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '84000', 'city': 'Avignon', 'country': 'France', 'facility': "CH d'Avignon", 'geoPoint': {'lat': 43.94834, 'lon': 4.80892}}, {'zip': '64100', 'city': 'Bayonne', 'country': 'France', 'facility': 'CH de la Cote Basque', 'geoPoint': {'lat': 43.49316, 'lon': -1.473}}, {'zip': '64100', 'city': 'Bayonne', 'country': 'France', 'facility': 'Clinique Lafourcade', 'geoPoint': {'lat': 43.49316, 'lon': -1.473}}, {'zip': '33000', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Clinique Saint Augustin', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '54500', 'city': 'Bourgogne', 'country': 'France', 'facility': 'CHU de Nancy', 'geoPoint': {'lat': 49.34962, 'lon': 4.07111}}, {'zip': '29200', 'city': 'Brest', 'country': 'France', 'facility': 'CHU la Cavale Blanche', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '71100', 'city': 'Chalon-sur-Saône', 'country': 'France', 'facility': 'CH William-Morey', 'geoPoint': {'lat': 46.78112, 'lon': 4.85372}}, {'zip': '36000', 'city': 'Châteauroux', 'country': 'France', 'facility': 'CHG de Chateauroux', 'geoPoint': {'lat': 46.81248, 'lon': 1.69362}}, {'zip': '92140', 'city': 'Clamart', 'country': 'France', 'facility': 'Hôpital Militaire', 'geoPoint': {'lat': 48.80299, 'lon': 2.26692}}, {'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '68000', 'city': 'Colmar', 'country': 'France', 'facility': 'Hôpital Albert Schweitzer', 'geoPoint': {'lat': 48.08078, 'lon': 7.35584}}, {'zip': '91106', 'city': 'Corbeil-Essonnes', 'country': 'France', 'facility': 'Centre Hospitalier Sud Francilien', 'geoPoint': {'lat': 48.60603, 'lon': 2.48757}}, {'zip': '40100', 'city': 'Dax', 'country': 'France', 'facility': 'CH de DAX', 'geoPoint': {'lat': 43.71032, 'lon': -1.05366}}, {'zip': '21000', 'city': 'Dijon', 'country': 'France', 'facility': 'CHU de Dijon', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'CHU Albert Michalon', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '67500', 'city': 'Haguenau', 'country': 'France', 'facility': 'CH de Haguenau', 'geoPoint': {'lat': 48.81557, 'lon': 7.79051}}, {'zip': '77400', 'city': 'Lagny-sur-Marne', 'country': 'France', 'facility': 'CH de Lagny sur Marne', 'geoPoint': {'lat': 48.86667, 'lon': 2.71667}}, {'zip': '33500', 'city': 'Libourne', 'country': 'France', 'facility': 'CH Robert Boulin', 'geoPoint': {'lat': 44.91449, 'lon': -0.24186}}, {'zip': '59000', 'city': 'Lille', 'country': 'France', 'facility': 'CHRU de Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '69007', 'city': 'Lyon', 'country': 'France', 'facility': 'CH St Luc St Joseph', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '69338', 'city': 'Lyon', 'country': 'France', 'facility': 'Clinique de la Sauvegarde', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '69394', 'city': 'Lyon', 'country': 'France', 'facility': 'Hôpital Cardiologique', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '13015', 'city': 'Marseille', 'country': 'France', 'facility': 'Hôpital Nord', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '13385', 'city': 'Marseille', 'country': 'France', 'facility': 'Hôpital La Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '91300', 'city': 'Massy', 'country': 'France', 'facility': 'Institut Jacques Cartier', 'geoPoint': {'lat': 48.72692, 'lon': 2.28301}}, {'zip': '93370', 'city': 'Montfermeil', 'country': 'France', 'facility': 'CHI de Montfermeil', 'geoPoint': {'lat': 48.8982, 'lon': 2.57913}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'CHU de Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '34960', 'city': 'Montpellier', 'country': 'France', 'facility': 'Clinique du Milénaire', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '03006', 'city': 'Moulins', 'country': 'France', 'facility': 'CH de Moulins', 'geoPoint': {'lat': 46.56459, 'lon': 3.33243}}, {'zip': '54100', 'city': 'Nancy', 'country': 'France', 'facility': 'Clinique Ambroise Paré', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'zip': '44.035', 'city': 'Nantes', 'country': 'France', 'facility': 'CHU G. & R. Laënnec', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'CHU Nîmes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Georges Pompidou', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '64000', 'city': 'Pau', 'country': 'France', 'facility': 'CH de Pau', 'geoPoint': {'lat': 43.31117, 'lon': -0.35583}}, {'zip': '66000', 'city': 'Perpignan', 'country': 'France', 'facility': 'Clinique Saint Pierre', 'geoPoint': {'lat': 42.69764, 'lon': 2.89541}}, {'zip': '33064', 'city': 'Pessac', 'country': 'France', 'facility': 'CHU Bordeaux', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'zip': '24000', 'city': 'Périgueux', 'country': 'France', 'facility': 'CH de Périgueux', 'geoPoint': {'lat': 45.18691, 'lon': 0.71439}}, {'zip': '86000', 'city': 'Poitiers', 'country': 'France', 'facility': 'CHU la Mileterie', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '35033', 'city': 'Rennes', 'country': 'France', 'facility': 'CHU (Hôpital Pontchaillou)', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '12027', 'city': 'Rodez', 'country': 'France', 'facility': 'CH de Rodez', 'geoPoint': {'lat': 44.35258, 'lon': 2.57338}}, {'zip': '76031', 'city': 'Rouen', 'country': 'France', 'facility': 'Chu Hôpital Charles Nicolle', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '22000', 'city': 'Saint-Brieuc', 'country': 'France', 'facility': 'CH de Saint Brieuc', 'geoPoint': {'lat': 48.51513, 'lon': -2.76838}}, {'zip': '42055', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'CHU de St-Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'zip': '16470', 'city': 'Saint-Michel', 'country': 'France', 'facility': "CH d'Angoulême", 'geoPoint': {'lat': 49.91952, 'lon': 4.13278}}, {'zip': '83100', 'city': 'Toulon', 'country': 'France', 'facility': 'Hôpital Font Pré', 'geoPoint': {'lat': 43.12442, 'lon': 5.92836}}, {'zip': '31076', 'city': 'Toulouse', 'country': 'France', 'facility': 'Clinique Pasteur', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '37044', 'city': 'Tours', 'country': 'France', 'facility': 'CHRU Tours (Hôpital Trousseau)', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'zip': '49800', 'city': 'Trélazé', 'country': 'France', 'facility': 'Clinique Saint Joseph', 'geoPoint': {'lat': 47.44629, 'lon': -0.46652}}, {'zip': '10003', 'city': 'Troyes', 'country': 'France', 'facility': 'CH de Troyes', 'geoPoint': {'lat': 48.30073, 'lon': 4.08524}}, {'zip': '26000', 'city': 'Valence', 'country': 'France', 'facility': 'CH de Valence', 'geoPoint': {'lat': 44.9256, 'lon': 4.90956}}, {'zip': '59300', 'city': 'Valenciennes', 'country': 'France', 'facility': 'CH de Valenciennes', 'geoPoint': {'lat': 50.35909, 'lon': 3.52506}}, {'zip': '56000', 'city': 'Vannes', 'country': 'France', 'facility': 'CH Bretagne Atlantique', 'geoPoint': {'lat': 47.65688, 'lon': -2.76205}}, {'zip': '69655', 'city': 'Villefranche-sur-Saône', 'country': 'France', 'facility': 'CH de Villefranche', 'geoPoint': {'lat': 45.98967, 'lon': 4.71961}}], 'overallOfficials': [{'name': 'Jean-Claude DEHARO, Pr. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital La Timone, 264 rue St. Pierre, 13385 MARSEILLE Cedex 5'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biotronik SE & Co. KG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}