Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2025-12-25 @ 5:21 PM
Study NCT ID:
NCT01265303
Status:
UNKNOWN
Last Update Posted:
2013-05-07
First Post:
2010-12-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Telemetric Arrhythmia and Syncope Diagnosis - Evaluation of Arrhythmia Treatment Efficacy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 360}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2014-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-05-06', 'studyFirstSubmitDate': '2010-12-22', 'studyFirstSubmitQcDate': '2010-12-22', 'lastUpdatePostDateStruct': {'date': '2013-05-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurence of atrial fibrillation', 'timeFrame': '14 days since the start of monitoring', 'description': 'Confirmation of indication for catheter ablation of atrial fibrillation by detection of incidence of AF event during 14 days ECG monitoring'}], 'secondaryOutcomes': [{'measure': 'Therapy efficacy analysis', 'timeFrame': '14 days', 'description': 'The mean atrial fibrillation burden reduction'}, {'measure': 'Indication for treatment other than catheter ablation', 'timeFrame': '14 days', 'description': 'Confirmation of indication for treatment other than catheter ablation such as: pacemaker or pharmacotherapy by detetion of:\n\n1. arrhythmia other than AF qualifying for treatment\n2. Bradycardia \\< 40 BPM\n3. Pauses \\> 2,5 s on sinus rhythm or \\> 3,5 on AF'}, {'measure': 'Correlation of patient self assessment based on the Quality of Life questionnaire and European Heart Rhythm Association (EHRA) scale with cardiac arrhythmia occurrence.', 'timeFrame': '14 days'}, {'measure': 'Evaluation of stroke and bleeding risk factors incidence based on scores proposed in the European Society of Cardiology (ESC) guidelines: CHADS2VASC2 and HAS-BLED', 'timeFrame': '14 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ablation, cardiac arrhythmia, atrial fibrillation, telemonitoring, telemetry'], 'conditions': ['Atrial Fibrillation', 'Arrhythmias, Cardiac']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess efficacy of prolonged Full Disclosure ECG monitoring and signal analysis using advanced GSM telemetric technology to prescribe the most appropriate treatment of arrhythmia.', 'detailedDescription': "Non-invasive methods enabling long-term ECG monitoring in patients with paroxysmal symptoms, such as tachycardia or palpitations increase the probability of detecting infrequent but dangerous events with profound clinical significance. Patients with recommendation for the first catheter ablation of Paroxysmal Atrial Fibrillation in the reference center will be included in the study. Eligible patients will have 14-day telemetric ECG monitoring. Based on detected arrhythmia events, patient's medical history and available documentation the most appropriate treatment will be recommended. Patients will undergo invasive procedures of ablation or pacemaker implantation or can be treated pharmacologically. After the invasive treatment or initiation of pharmacotherapy the 14-day telemetric ECG monitoring will be repeated to assess efficacy of the treatment.\n\nPatients with no record of arrhythmia requiring treatment during the first 14 days ECG monitoring will terminate participation in the study. The referring physician will be informed. Further diagnosis or treatment should be performed at the referring physician's center according to the best clinical practice."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age - between 18 and 80 years old\n* Physician recommendation for ablation treatment of arrhythmia\n* Patient informed consent\n* Declarative and feasible compliance (patient understands basic instructions regarding device use)\n\nExclusion Criteria:\n\n* Inability to comply with the study protocol\n* Lack of patient cooperation'}, 'identificationModule': {'nctId': 'NCT01265303', 'acronym': 'TELEMARC 4', 'briefTitle': 'Telemetric Arrhythmia and Syncope Diagnosis - Evaluation of Arrhythmia Treatment Efficacy', 'organization': {'class': 'OTHER', 'fullName': 'National Institute of Cardiology, Warsaw, Poland'}, 'officialTitle': 'OPTIMIZING DIAGNOSTICS AND THERAPY OF ARRHYTHMIA AND SYNCOPE EVENTS USING INTELLIGENT TELEMETRIC SOLUTIONS - Evaluation of Arrhythmia Treatment Efficacy', 'orgStudyIdInfo': {'id': 'UDAPOIG.01.03.01-00-068/09-00D'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Catheter ablation', 'interventionNames': ['Device: Prolonged telemetric Full Disclosure ECG recording.']}, {'type': 'OTHER', 'label': 'Pacemaker implantation', 'interventionNames': ['Device: Prolonged telemetric Full Disclosure ECG recording.']}, {'type': 'OTHER', 'label': 'Pharmacotherapy', 'interventionNames': ['Device: Prolonged telemetric Full Disclosure ECG recording.']}], 'interventions': [{'name': 'Prolonged telemetric Full Disclosure ECG recording.', 'type': 'DEVICE', 'otherNames': ['Medicalgorithmics, PocketECG'], 'description': 'Continuous Full Disclosure Telemetric ECG monitoring lasting 14 days', 'armGroupLabels': ['Catheter ablation', 'Pacemaker implantation', 'Pharmacotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Brussels', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Pedro Brugada, MD PhD', 'role': 'CONTACT', 'email': 'chvz@uzbrussel.be', 'phone': '+32 2 477 60 09'}, {'name': 'Carlo de Asmundis, MD', 'role': 'CONTACT', 'email': 'chvz@uzbrussel.be', 'phone': '+32 2 477 60 09'}, {'name': 'Carlo de Asmundis, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitair Ziekenhuis Brussel Centre for Heart- and Vascular diseases', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '04-073', 'city': 'Warsaw', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Piotr KuĊakowski, MD PhD', 'role': 'CONTACT', 'email': 'kulak@kkcmkp.pl', 'phone': '+48 22 8101738'}, {'name': 'Jakub Baran, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sebastian Stec, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Klinika Kardiologii CMKP', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '04-628', 'city': 'Warsaw', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Lukasz Szumowski, Prof,', 'role': 'CONTACT', 'email': 'lszumowski@ikard.pl', 'phone': '+48 22 501152728'}, {'name': 'Lukasz Szumowski, Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Zbigniew Jedynak, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Institute of Cardiology', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'centralContacts': [{'name': 'Lukasz Szumowski, MD, PhD', 'role': 'CONTACT', 'email': 'lszumowski@ikard.pl', 'phone': '+48501152728'}, {'name': 'Zbigniew Jedynak, MD, PhD', 'role': 'CONTACT', 'email': 'zjedynak@ikard.pl', 'phone': '+48603786780'}], 'overallOfficials': [{'name': 'Lukasz J Szumowski, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'National Institute of Cardiology, Warsaw, Poland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Cardiology, Warsaw, Poland', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Prof Lukasz Szumowski', 'oldOrganization': 'Institute of Cardiology, Warsaw Poland'}}}}