Ignite Creation Date:
2025-12-24 @ 6:32 PM
Ignite Modification Date:
2025-12-24 @ 6:32 PM
Study NCT ID:
NCT04293757
Status:
COMPLETED
Last Update Posted:
2023-11-21
First Post:
2020-02-24
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Rotational Angiography in Cryoballoon Ablation
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-20', 'studyFirstSubmitDate': '2020-02-24', 'studyFirstSubmitQcDate': '2020-03-01', 'lastUpdatePostDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ablation success rates', 'timeFrame': '1 year', 'description': 'comparison of freedom from atrial fibrillation after ablation procedure'}], 'secondaryOutcomes': [{'measure': 'procedure duration', 'timeFrame': '1 year', 'description': 'comparison of time required to finish the ablation procedure'}, {'measure': 'radiation exposure', 'timeFrame': '1 year', 'description': 'comparison of radiation exposure measured in fluoroscopy time (minutes) and X ray dosage measured in mGy and mcGy/m2.'}, {'measure': 'contrast expenditure', 'timeFrame': '1 year', 'description': 'comparison of contrast expenditure (milliliters of contrast used) between 2 groups'}, {'measure': 'complication rates', 'timeFrame': '1 year', 'description': 'comparison of complication rates between 2 groups'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['preprocedural imaging', 'Atrial Fibrillation', 'Rotational angiography'], 'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'There is still unresolved question weather preprocedural imaging of left atrium and pulmonary veins is needed before the pulmonary vein isolation procedure for the treatment of atrial fibrillation. The investigators are conducting a randomized study to determine if 3D rotational angiography (as a mode of preprocedural imaging) performed before the cryoballoon ablation, facilitates the procedure and has positive impact on procedure characteristics and outcomes.', 'detailedDescription': 'Around 50% of cardiac electrophysiology (EP) centers are using some kind of imaging to define left atrium and pulmonary vein anatomy before the pulmonary vein isolation (PVI) procedure. Most commonly, CT or MR are performed few days/weeks before the procedure. Three dimensional rotational angiography is least commonly used. However it has the advantage that it can be performed in the EP room just before the ablation procedure. There is still no consensus if any kind of imaging is really needed to perform safe and effective PVI.\n\nThe investigators want to determine if 3D rotational angiography (as a mode of preprocedural imaging) has positive impact on procedure safety and efficacy. Also the investigators want to compare the immediate procedure characteristics. The investigators are conducting a randomized study with 1:1 randomization and planning to enroll around 100 participants with 1 year follow up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* paroxysmal atrial fibrillation\n* persistent atrial fibrillation\n* scheduled for cryoballoon ablation\n\nExclusion Criteria:\n\n* longstanding persistent atrial fibrillation\n* renal failure\n* contrast allergy'}, 'identificationModule': {'nctId': 'NCT04293757', 'briefTitle': 'Rotational Angiography in Cryoballoon Ablation', 'organization': {'class': 'OTHER', 'fullName': 'University of Zagreb'}, 'officialTitle': 'Preprocedural Imaging by Rotational Angiography in Cryoballoon Ablation for Atrial Fibrillation', 'orgStudyIdInfo': {'id': 'RA001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rotational angio', 'description': 'Patients that will undergo 3D rotational angiography before cryoballoon ablation', 'interventionNames': ['Procedure: Rotational angiography']}, {'type': 'NO_INTERVENTION', 'label': 'No rotational angio', 'description': 'Patients that will receive no preprocedural imaging before cryoballoon ablation'}], 'interventions': [{'name': 'Rotational angiography', 'type': 'PROCEDURE', 'description': 'Preprocedural imaging before ablation', 'armGroupLabels': ['Rotational angio']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10000', 'city': 'Zagreb', 'country': 'Croatia', 'facility': 'KBC Zagreb', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}], 'overallOfficials': [{'name': 'Vedran Velagić, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Hospital Centre Zagreb'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zagreb', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor, MD, PhD', 'investigatorFullName': 'Vedran Velagic', 'investigatorAffiliation': 'University of Zagreb'}}}}