Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2026-03-03 @ 4:29 AM
Study NCT ID:
NCT04198220
Status:
COMPLETED
Last Update Posted:
2021-10-22
First Post:
2019-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BIO|STREAM.ICM Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D013575', 'term': 'Syncope'}, {'id': 'D001919', 'term': 'Bradycardia'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D009765', 'term': 'Obesity'}], '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'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-21', 'studyFirstSubmitDate': '2019-12-12', 'studyFirstSubmitQcDate': '2019-12-12', 'lastUpdatePostDateStruct': {'date': '2021-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Incidence of arrhythmias', 'timeFrame': '3 month', 'description': 'Assessment of the incidence of arrhythmias in obese patients implanted with an ICM'}], 'primaryOutcomes': [{'measure': 'R-wave amplitude', 'timeFrame': '3 month', 'description': 'R-wave amplitude at 3-month Home Monitoring observation in patients with a BMI \\> 30'}], 'secondaryOutcomes': [{'measure': "Amount of 'noise burden'", 'timeFrame': '3 month', 'description': "Measurement of amount of 'noise burden' during the study period"}, {'measure': 'P-wave visibility', 'timeFrame': '1 month and 3 month', 'description': 'Measurement of the P-wave visibility at 1- and 3-month Home Monitoring observation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obesity', 'BIOMONITOR', 'BIOMONITOR III', 'Syncope', 'Cryptogenic stroke', 'Atrial Fibrillation'], 'conditions': ['Tachycardia Atrial', 'Atrial Fibrillation', 'Syncope', 'Bradycardia', 'Cryptogenic Stroke']}, 'referencesModule': {'references': [{'pmid': '37025684', 'type': 'DERIVED', 'citation': 'Bisignani G, De Bonis S, Pierre B, Lau DH, Hofer D, Sanfins VM, Hain A, Cabanas P, Martens E, Berruezo A, Eschalier R, Milliez P, Lusebrink U, Mansourati J, Papaioannou G, Giacopelli D, Gargaro A, Ploux S. Insertable cardiac monitor with a long sensing vector: Impact of obesity on sensing quality and safety. Front Cardiovasc Med. 2023 Mar 21;10:1148052. doi: 10.3389/fcvm.2023.1148052. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the submodule study is to assess whether a high BMI may influence the sensing performance and the sECG quality of the BIOMONITOR.', 'detailedDescription': 'This submodule of the BIO\\|STREAM.ICM registry specifically investigates the performance of the BIOMONITOR in a subset of obese patients with a BMI \\>30 kg/m2 in order to exclude any concerns regarding impaired ICM sensing performance. These concerns are founded in the increased distance between heart and device electrodes due to fat layers that may attenuate signal detection and therefore sensing performances of the ICM.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The patient population consists of obese patients (BMI \\> 30 kg/m2) with an implantable cardiac monitor', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is already enrolled in the BIO\\|STREAM.ICM registry\n* Patient BMI \\> 30\n\nExclusion Criteria:\n\n* Patient clinically indicated for or already implanted with another cardiac active device'}, 'identificationModule': {'nctId': 'NCT04198220', 'briefTitle': 'BIO|STREAM.ICM Obesity', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biotronik SE & Co. KG'}, 'officialTitle': 'BIO|STREAM.ICM Obesity, Submodule of the BIO|STREAM.ICM Registry', 'orgStudyIdInfo': {'id': 'HS064'}}, 'contactsLocationsModule': {'locations': [{'zip': '87012', 'city': 'Castrovillari', 'country': 'Italy', 'facility': 'Ospedale Civile Ferrari', 'geoPoint': {'lat': 39.81632, 'lon': 16.20183}}], 'overallOfficials': [{'name': 'Giovanni Bisignani, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ospedale Civile Ferrari'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biotronik SE & Co. KG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}