Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-25 @ 11:33 PM
Study NCT ID:
NCT03401593
Status:
NOT_YET_RECRUITING
Last Update Posted:
2019-08-29
First Post:
2017-12-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Long Term Evaluation and Management of Atrial Fibrillation in Pacemaker Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D020521', 'term': 'Stroke'}], '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': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008874', 'term': 'Midazolam'}, {'id': 'D005283', 'term': 'Fentanyl'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 135}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-08-28', 'studyFirstSubmitDate': '2017-12-27', 'studyFirstSubmitQcDate': '2018-01-09', 'lastUpdatePostDateStruct': {'date': '2019-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence rate of AF/AFL/AT in both groups', 'timeFrame': '1 year after randomization', 'description': 'recurrence of AF/AFL/AT evaluated using device interrogation'}, {'measure': 'Recurrence rate of AF/AFL/AT in both groups', 'timeFrame': '6-month follow up to 5 years', 'description': 'recurrence of AF/AFL/AT evaluated using device interrogation'}], 'secondaryOutcomes': [{'measure': 'Left ventricular ejection fraction', 'timeFrame': '1 year after randomization', 'description': 'cardiac function evaluated using echocardiography'}, {'measure': 'Left atrial diameter', 'timeFrame': '1 year after randomization', 'description': 'cardiac function evaluated using echocardiography'}, {'measure': 'Stroke', 'timeFrame': 'at least 1 year after randomization', 'description': 'ischemic and hemorrhagic stroke'}, {'measure': 'Stroke', 'timeFrame': '6-month follow up to 5 years', 'description': 'ischemic and hemorrhagic stroke'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ablation', 'atrial fibrillation', 'stroke'], 'conditions': ['Permanent Pacemaker Implantation']}, 'descriptionModule': {'briefSummary': 'This study is prospective randomized study which was performed in multicenter (General Hospital) in Korea. Inclusion criteria is patients who developed atrial fibrillation/flutter/tachycardia after pacemaker implantation among AF-pacemaker study (ClinicalTrials.gov Identifier: NCT03303872). The purpose is to investigate the recurrence rate of AF/AFL/AT in both groups after randomization for 60 months (5 years) in patients post pacemaker implantation and assess long term clinical results.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who developed atrial fibrillation/flutter/tachycardia after pacemaker implantation among AF-pacemaker study (ClinicalTrials.gov Identifier: NCT03303872).\n* Age: 18-80 years\n* Patients eligible for the indications for permanent pacemaker implantation in accordance with 2016 revised Korean indication guideline on cardiac pacemaker implantation\n* Estimated percentage of atrial pacing \\>40% under sinus rhythm (LR≥60bpm, close hysteresis and rest rate)\n* Estimated percentage of ventricular pacing \\>40% under sinus rhythm (LR≥40bpm, DDD pacing, close hysteresis and rest rate)\n* Patients who are willing to sign the informed consent.\n* Patients who are willing to receive the implantation and post-operative follow-up.\n\nExclusion Criteria:\n\n* Persistent or permanent AF\n* Severe hepatic and renal insufficiency (AST or ALT ≥ three times of normal upper limit; SCr \\> 3.5 mg/dl or Ccr \\< 30ml/min)\n* Thyroid gland dysfunction\n* Pregnancy\n* Malignant tumor\n* Severe organic heart disease (such as moderate to severe mitral regurgitation, severe valvular regurgitation and stenosis, dilated cardiomyopathy, hypertrophic cardiomyopathy, severe heart valve disease)\n* Life expectancy \\< 12 months\n* Patients unable or unwilling to cooperate in the study procedures.'}, 'identificationModule': {'nctId': 'NCT03401593', 'briefTitle': 'Long Term Evaluation and Management of Atrial Fibrillation in Pacemaker Patients', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Long Term Evaluation and Management of Atrial Fibrillation in Pacemaker Patients (AF-pacemaker Tx Study)', 'orgStudyIdInfo': {'id': '4-2017-1028'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ablation', 'description': 'Patients in this group are treated with radio-frequency catheter ablation.', 'interventionNames': ['Drug: midazolam with fentanyl']}, {'type': 'NO_INTERVENTION', 'label': 'non-ablation', 'description': 'Patients in this group are treated with rate control medications (e.g., beta blocker, calcium channel blocker, and digitalis) and anti-arrhythmic drugs. They also can be treated with DC cardio-version.'}], 'interventions': [{'name': 'midazolam with fentanyl', 'type': 'DRUG', 'description': 'Radio-frequency catheter ablation is performed in the post-absorptive state after sedation with midazolam and fentanyl. Multipolar catheters were positioned in the coronary sinus, His, and the right atrium. The three-dimensional LA geometry was reconstructed using a CARTO or NavX electroanatomical mapping system. Circumferential pulmonary vein isolation was performed in all patients using a irrigated-tip catheter. A circular mapping catheter was used to confirm the isolation of the pulmonary veins. Successful ablation was defined by the elimination of all the pulmonary vein potentials along the antrum or inside the veins. If the AF was not terminated after elimination of all the pulmonary vein potentials, linear ablation and complex fragmented atrial electrogram ablation were performed.', 'armGroupLabels': ['ablation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03722', 'city': 'Seoul', 'country': 'South Korea', 'contacts': [{'name': 'Boyoung Joung, MD, Ph.D', 'role': 'CONTACT', 'email': 'cby6908@yuhs.ac', 'phone': '82-2-2228-8460'}], 'facility': 'Division of Cardiology, Yonsei University Health System, Yonsei University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}