Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2026-02-21 @ 1:02 PM
Study NCT ID:
NCT02317068
Status:
COMPLETED
Last Update Posted:
2015-10-21
First Post:
2014-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Increasing Atrial Base Rate Pacing to Reduce Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012804', 'term': 'Sick Sinus Syndrome'}, {'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001146', 'term': 'Arrhythmia, Sinus'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006327', 'term': 'Heart Block'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-20', 'studyFirstSubmitDate': '2014-12-10', 'studyFirstSubmitQcDate': '2014-12-10', 'lastUpdatePostDateStruct': {'date': '2015-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Atrial high rate/Automatic mode switch episodes', 'timeFrame': 'During 6 Months', 'description': 'The number of AHR/AMS episodes recorded by pacemaker'}], 'secondaryOutcomes': [{'measure': 'Stroke', 'timeFrame': 'During 6 months', 'description': 'The development of stroke during follow-up'}, {'measure': 'Myocardial infarction', 'timeFrame': 'During 6 months', 'description': 'The development of MI during follow-up confirmed by ischemic chest pain, 12-ECG, or cardiac enzyme elevation'}, {'measure': 'Heart failure', 'timeFrame': 'During 6 months', 'description': 'The development or progression of heart failure during follow-up'}, {'measure': 'Worsening Functional Class', 'timeFrame': 'During 6 months', 'description': 'The worsening of functional class'}, {'measure': 'Death', 'timeFrame': 'During 6 months', 'description': 'Death'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['sick sinus syndrome', 'paroxysmal atrial fibrillation', 'atrial pacing', 'high atrial base rate pacing'], 'conditions': ['Sick Sinus Syndrome', 'Paroxysmal Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'This study aims to determine whether increasing atrial base rate pacing to achieve at least 75-80% atrial pacing in patients with sick sinus syndrome undergoing the implementation of dual-chamber pacemaker can be useful to prevent or decrease the atrial fibrillation during 6 months follow-up duration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sick sinus syndrome patients having dual-chamber pacemaker\n* Having paroxysmal AF defined as at least 2 episodes of AHR/AMS \\>190 b/min lasting \\>6 minutes\n* Having normal atrioventricular conduction\n\nExclusion Criteria:\n\n* Other clinical indications for pacing except sick sinus syndrome (bradycardia-tachycardia syndrome)\n* History of acute coronary syndrome\n* Significant heart valve disease\n* Chronic AF before randomization\n* Overt heart failure\n* Malignancy\n* Any reasons for antiarrhythmic medication use\n* Inability to follow patients every 3 months'}, 'identificationModule': {'nctId': 'NCT02317068', 'briefTitle': 'Increasing Atrial Base Rate Pacing to Reduce Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'Urmia University of Medical Sciences'}, 'orgStudyIdInfo': {'id': 'UMSU-Cardiology-4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High Atrial Base Rate Pacing', 'description': 'The base rate of pacemaker will be determined 75-100 beats/minute in condition that during first step of follow-up, his/her atrial pacing will be more than 80% of atrial high rate/automatic mode switch', 'interventionNames': ['Device: HBR']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Device Default', 'description': 'The base rate of pacemaker will be determined 60 beats/minute', 'interventionNames': ['Device: DD']}], 'interventions': [{'name': 'HBR', 'type': 'DEVICE', 'otherNames': ['High Atrial Base Rate Pacing'], 'armGroupLabels': ['High Atrial Base Rate Pacing']}, {'name': 'DD', 'type': 'DEVICE', 'otherNames': ['Device Default'], 'armGroupLabels': ['Device Default']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Urmia', 'state': 'West Azerbaijan Province', 'country': 'Iran', 'facility': 'Seyyed-al-Shohada Heart Center, UMSU', 'geoPoint': {'lat': 37.55274, 'lon': 45.07605}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Urmia University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice-Chancellor for Research in UMSU', 'investigatorFullName': 'Chancellor of research', 'investigatorAffiliation': 'Urmia University of Medical Sciences'}}}}