Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2025-12-25 @ 4:36 PM
Study NCT ID:
NCT04379557
Status:
UNKNOWN
Last Update Posted:
2020-05-07
First Post:
2020-03-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ablation Index Guided High Power Ablation for Pulmonary Vein Isolation in Patients With Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017115', 'term': 'Catheter Ablation'}], 'ancestors': [{'id': 'D000078703', 'term': 'Radiofrequency Ablation'}, {'id': 'D000078702', 'term': 'Radiofrequency Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2020-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-04', 'studyFirstSubmitDate': '2020-03-17', 'studyFirstSubmitQcDate': '2020-05-04', 'lastUpdatePostDateStruct': {'date': '2020-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ablation time', 'timeFrame': 'during procedure', 'description': 'To compare ablation time of ablation index guided high power ablation for pulmonary vein isolation in patients with atrial fibrillation'}], 'secondaryOutcomes': [{'measure': 'residual potential after first pass pulmonary vein encirclement', 'timeFrame': 'during procedure', 'description': 'segment which observed residual potential after first pass pulmonary vein encirclement during procedure (based on predefined pulmonary vein segments)'}, {'measure': 'acute pulmonary vein reconnection', 'timeFrame': '1 year', 'description': 'segment which observed early re-connection during procedure (based on predefined pulmonary vein segments) time frame: during procedure (20-30 minutes after pulmonary vein isolation)'}, {'measure': 'any atrial fibrillation/atrial tachycardia recurrence', 'timeFrame': '1-year after index procedure', 'description': 'detected by 12-lead electrocardiogram or 24-hour holter monitoring'}, {'measure': 'Total time', 'timeFrame': 'during procedure', 'description': 'Total ablation time, fluoroscopic time, and procedure time'}, {'measure': 'Rate of Complication', 'timeFrame': '1 year', 'description': 'Complications associated with procedure.(bleeding, cardiac tamponade, etc.)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '34621423', 'type': 'DERIVED', 'citation': 'Lee SR, Park HS, Choi EK, Lee E, Oh S. Acute and long-term efficacy of ablation index-guided higher power shorter duration ablation in patients with atrial fibrillation: A prospective registry. J Arrhythm. 2021 Jul 21;37(5):1250-1259. doi: 10.1002/joa3.12605. eCollection 2021 Oct.'}]}, 'descriptionModule': {'briefSummary': 'The investigators will compare the ablation time during pulmonary vein isolation of Ablation Index-guided high power ablation with those with conventional ablation.\n\nAblation time of conventional group will be used from OPTIMUM study. For secondary outcomes, acute outcomes of pulmonary vein isolation using two different strategies will be compared. During 1 year of follow-up in both groups, atrial fibrillation recurrence will be evaluated. The atrial fibrillation recurrence rate at 1 year after pulmonary vein isolation will be compared between the two groups. In addition, fluoroscopic time, procedure time, and complication rates for the high power ablation group will be compared with those with conventional power.', 'detailedDescription': 'Ablation Index guided high power ablation will be performed in 70 patients with atrial fibrillation with prospectively and consecutively. A contact force-sensing catheter will be used. Ablation will be performed with point-by-point technique using Visitag automated annotation criteria as below;\n\nAblation Index(AI) target:\n\n* Anterior/roof : 450 AI\n* Anterior near carina area : 500 AI\n* Posterior/inferior/carina : 350 AI\n* Posterior near carina area : 400 AI\n* Area near esophagus :25W, 15sec or 300 AI (no further ablation if esophageal temperature increase more than 39°C)\n* Interlesion distance ≤ 4.5mm\n\nVISITAGTM settings\n\n* 2.5mm stability range\n* 7 sec stability time\n* FOT 25%, 3g force\n* Tag size 2mm\n\nAblation parameters are preset as below;\n\n* RF power range: 40W at anterior/roof, 30W at posterior/inferior, 25W at near esophagus area (decrease power 5W by operator decision)\n* Target contact force range: 10-20 g\n* Flow rate:\n* 8 ml/min for STSF \\< 30W\n* 15 ml/min for STSF ≥ 30W\n\nAcute reconnection will be analysed according to predefined segments.\n\nSubgroup analysis will be performed according to type of AF. Data of patients with paroxysmal atrial fibrillation and persistent atrial fibrillation will be analysed separately, and investigate whether this new ablation strategy is effective in both group of patients. To compare outcomes with OPITMUM phase 2 study, the proportion of patients with paroxysmal and persistent atrial fibrillation would be 75% and 25%. Therefore, 53 patients with paroxysmal atrial fibrillation and 17 patients with persistent atrial fibrillation will be enrolled in this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with symptomatic paroxysmal or persistent AF who failed anti-arrhythmic agents\n\nExclusion Criteria:\n\n* Patients who had previous ablation for AF\n* Patients with left atrial diameter more than 50 mm\n* Inability or unwillingness to receive oral anticoagulation with a vitamin K antagonist (VKA) or non-VKA (NOAC) agent\n* Known severe left ventricular systolic dysfunction (ejection fraction \\<35%)\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT04379557', 'briefTitle': 'Ablation Index Guided High Power Ablation for Pulmonary Vein Isolation in Patients With Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Ablation Index Guided High Power Ablation for Pulmonary Vein Isolation in Patients With Atrial Fibrillation', 'orgStudyIdInfo': {'id': 'LESS AF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High power ablation', 'description': 'Ablation Index guided high power ablation (radio frequency energy: Left atrium anterior segment and roof: 40W, Left atrium inferior/posterior: 30W, near esophagus: 25W)', 'interventionNames': ['Procedure: Catheter Ablation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional ablation', 'description': 'Conventional ablation applying 30-35W strategy for Left atrium anterior segments.', 'interventionNames': ['Procedure: Catheter Ablation']}], 'interventions': [{'name': 'Catheter Ablation', 'type': 'PROCEDURE', 'description': 'Catheter Ablation is a procedure used to remove or terminate a faulty electrical pathway from sections of the hearts of those who are prone to developing cardiac arrhythmias', 'armGroupLabels': ['Conventional ablation', 'High power ablation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'state': 'Jongno-gu', 'country': 'South Korea', 'facility': 'Seoul National university Hostpital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Euekeun Choi, M.D. Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}