Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2025-12-28 @ 4:30 PM
Study NCT ID:
NCT01725568
Status:
COMPLETED
Last Update Posted:
2014-11-20
First Post:
2012-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BioMonitor Master Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D013575', 'term': 'Syncope'}], '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'}, {'id': 'D014474', 'term': 'Unconsciousness'}, {'id': 'D003244', 'term': 'Consciousness Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 152}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-19', 'studyFirstSubmitDate': '2012-11-06', 'studyFirstSubmitQcDate': '2012-11-13', 'lastUpdatePostDateStruct': {'date': '2014-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Sensitivity and Positive Predictive of episode detection', 'timeFrame': '1 year', 'description': 'Sensitivity and Positive Predictive Value of each automatically detected cardiac arrhythmia that was stored as subcutaneous electrocardiogram by the BioMonitor (6 week, 3 and 12 month follow-up data)'}, {'measure': 'Adverse events', 'timeFrame': '1 year'}], 'primaryOutcomes': [{'measure': 'SADE free-rate', 'timeFrame': 'at 3 month follow-up', 'description': 'SADE free-rate \\> 90% at 3 month follow-up'}, {'measure': 'Rate of appropriate QRS detection', 'timeFrame': 'at 6 week follow-up', 'description': 'Rate of appropriate QRS detection \\> 90% (based on comparison with Holter ECG recording)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['ATRIAL FIBRILLATION, Syncope']}, 'descriptionModule': {'briefSummary': 'The BioMonitor is an implantable cardiac monitor used to automatically detect and record episodes of arrhythmia in patients with bradycardia, tachycardia, asystole and atrial fibrillation. The study will be conducted to support regulatory approvals outside of Europe. This BioMonitor Master study is designed to investigate the clinical efficacy and safety of the BioMonitor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with standard ICM indication who are referred to the hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Suspected cardiac arrhythmia OR Previous AF diagnosis OR AF diagnosis before or after ablation procedure OR Stroke of unknown origin.\n\nExclusion Criteria:\n\n* Implanted ICD or cardiac pacemaker\n* Allergy to patch electrodes'}, 'identificationModule': {'nctId': 'NCT01725568', 'acronym': 'BioMonitor', 'briefTitle': 'BioMonitor Master Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biotronik SE & Co. KG'}, 'officialTitle': 'Master Study of the Implantable Cardiac Monitor "BioMonitor"', 'orgStudyIdInfo': {'id': '60'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Implantable cardiac monitor diagnostics', 'description': 'Patients has standard indication for implantable cardiac monitor diagnostic.', 'interventionNames': ['Device: BioMonitor']}], 'interventions': [{'name': 'BioMonitor', 'type': 'DEVICE', 'description': 'Implantable cardiac monitor', 'armGroupLabels': ['Implantable cardiac monitor diagnostics']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18057', 'city': 'Rostock', 'country': 'Germany', 'facility': 'University of Rostock', 'geoPoint': {'lat': 54.0887, 'lon': 12.14049}}], 'overallOfficials': [{'name': 'Dietmar Baensch, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Rostock, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biotronik SE & Co. KG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}