Ignite Creation Date:
2025-12-24 @ 12:17 PM
Ignite Modification Date:
2025-12-28 @ 4:52 PM
Study NCT ID:
NCT04055961
Status:
UNKNOWN
Last Update Posted:
2023-02-28
First Post:
2019-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Atrial Fibrillation Ablation Registry
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': 'OTHER', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2025-05-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-27', 'studyFirstSubmitDate': '2019-08-08', 'studyFirstSubmitQcDate': '2019-08-12', 'lastUpdatePostDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Unsuccessful treatment rate', 'timeFrame': '1 year', 'description': 'measured by the number of repeated procedure'}], 'secondaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': '1 year', 'description': 'Number of participants with adverse events that are related to treatment (i.e. cardiac tamponade, periprocedural stroke, pulmonary vein stenosis, esophageal damage, etc)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'The Atrial Fibrillation Ablation Registry (AFib Ablation Registry™) is designed to assess the prevalence, demographics, management, and outcomes of patients undergoing percutaneous catheter ablation procedures to treat atrial fibrillation (AF).', 'detailedDescription': "The Atrial Fibrillation Ablation Registry (AFib Ablation Registry™) is designed to assess the prevalence, demographics, management, and outcomes of patients undergoing percutaneous catheter ablation procedures to treat atrial fibrillation (AF). Patient-level data will be submitted by participating hospitals on a quarterly basis to the American College of Cardiology Foundation's National Cardiovascular Data Registry (NCDR™). The primary aims of the AFib Ablation Registry are to optimize the outcomes and management of patients through the implementation of evidence-based guideline recommendations in clinical practice, facilitate efforts to improve the quality and safety for patients undergoing percutaneous catheter ablation procedures, investigate novel quality improvement methods and provide risk-adjusted assessment of patients for comparison with nationwide NCDR data. The secondary purpose of the AFib Ablation Registry is to serve as a rich source of clinical data to support assessments of short- and long-term safety, comparative and cost effectiveness research, and as a scalable data infrastructure for post market studies."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients, 18 years and older, undergoing percutaneous catheter ablation procedures to treat atrial fibrillation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult patients\n2. 18 years and older\n3. Undergoing percutaneous catheter ablation procedures to treat atrial fibrillation\n\nExclusion Criteria:\n\n1\\. none'}, 'identificationModule': {'nctId': 'NCT04055961', 'acronym': 'AFib', 'briefTitle': 'Atrial Fibrillation Ablation Registry', 'organization': {'class': 'OTHER', 'fullName': 'Hoag Memorial Hospital Presbyterian'}, 'officialTitle': 'Atrial Fibrillation Ablation Registry Protocol Number: 3122-2016', 'orgStudyIdInfo': {'id': '171-19-CV'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Atrial Fibrillation Ablation', 'type': 'DEVICE', 'description': 'A procedure used to treat an irregular heart rhythm (arrhythmia)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Colleen Balius, BSN, RN', 'role': 'CONTACT', 'email': 'colleen.balius@hoag.org', 'phone': '949-764-1497'}, {'name': 'Colleen Balius, BSN, RN', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hoah Memorial Hospital Presbyterian', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}], 'centralContacts': [{'name': 'Colleen Balius', 'role': 'CONTACT', 'email': 'colleen.balius@hoag.org', 'phone': '9497641497'}], 'overallOfficials': [{'name': 'Leila Andres', 'role': 'STUDY_CHAIR', 'affiliation': 'Hoag Memorial Hospital Presbyterian'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoag Memorial Hospital Presbyterian', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Data Coordinator', 'investigatorFullName': 'Colleen Balius', 'investigatorAffiliation': 'Hoag Memorial Hospital Presbyterian'}}}}