Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-31 @ 5:40 PM
Study NCT ID:
NCT04859933
Status:
COMPLETED
Last Update Posted:
2022-08-09
First Post:
2021-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AV Node Isolation in Atrial Fibrillation vs. Modulation by "Pace and Ablate" Strategy
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-08', 'studyFirstSubmitDate': '2021-04-22', 'studyFirstSubmitQcDate': '2021-04-22', 'lastUpdatePostDateStruct': {'date': '2022-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AV-node escape rhythm', 'timeFrame': 'intraoperative, follow-up after 1 to 3 month'}, {'measure': 'bundle branch blocks', 'timeFrame': 'intraoperative, follow-up after 1 to 3 month'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation', 'AV Node Ablation', 'Escape; Rhythm']}, 'descriptionModule': {'briefSummary': 'AV-node ablation (AVNA) is a common therapy option for rate control strategy of permanent atrial fibrillation with numerous side effects. The investigators hypothesised that an isolation of the AV node is concomitant with less occurrence of new bundle brunch blocks, more frequent preservation and higher rate of escape rhythm compared to AVNA. This retrospective study includes 20 patients being treated with AV-node isolation (AVNI) and 40 historical AVNA-controls. Among others these two methods were compared regarding escape rhythm, delta QRS, procedure time, ablation points, fluoroscopy time and total dose area product (DAP).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to Heart- and Diabetes Centre NRW for AV-node ablation/isolation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* paroxysmal, persistend or permanent atrial fibrillation; indication for AVNA\n\nExclusion Criteria:\n\n* other indications for AVNA than atrial fibrillation as AVNRT, atrial flutter, atrial tachycardia'}, 'identificationModule': {'nctId': 'NCT04859933', 'briefTitle': 'AV Node Isolation in Atrial Fibrillation vs. Modulation by "Pace and Ablate" Strategy', 'organization': {'class': 'OTHER', 'fullName': 'Heart and Diabetes Center North-Rhine Westfalia'}, 'officialTitle': 'AV Node Isolation in Atrial Fibrillation vs. Modulation by "Pace and Ablate" Strategy', 'orgStudyIdInfo': {'id': 'HDZ_ER_003_GI'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'AVNA group', 'description': 'Group of historical controls beeing treated with AV-node ablation', 'interventionNames': ['Procedure: AV-node ablation']}, {'label': 'AVNI group', 'description': 'Inculudes all patients beeing treated with AV-node isolation', 'interventionNames': ['Procedure: AV-node isolation']}], 'interventions': [{'name': 'AV-node isolation', 'type': 'PROCEDURE', 'otherNames': ['AVNI'], 'description': 'Abaltion performed in the right atrium isolating the AV-node from the atrium', 'armGroupLabels': ['AVNI group']}, {'name': 'AV-node ablation', 'type': 'PROCEDURE', 'otherNames': ['AVNA'], 'description': 'Right sided ablation of the AV-node', 'armGroupLabels': ['AVNA group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32545', 'city': 'Bad Oeynhausen', 'country': 'Germany', 'facility': 'Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum', 'geoPoint': {'lat': 52.20699, 'lon': 8.80365}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heart and Diabetes Center North-Rhine Westfalia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}