Ignite Creation Date:
2025-12-24 @ 5:07 PM
Ignite Modification Date:
2026-02-06 @ 4:23 PM
Study NCT ID:
NCT02830750
Status:
COMPLETED
Last Update Posted:
2018-04-26
First Post:
2016-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low Fluoroscopy Afib 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': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-24', 'studyFirstSubmitDate': '2016-06-28', 'studyFirstSubmitQcDate': '2016-07-12', 'lastUpdatePostDateStruct': {'date': '2018-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Atrial Fibrillation', 'timeFrame': '12 months', 'description': 'Determine Atrial Fibrillation burden at 12 month visit by reviewing monitoring systems that capture this data'}], 'secondaryOutcomes': [{'measure': 'Fluoroscopic Usage', 'timeFrame': 'post operative', 'description': 'To determine total amount of radiation used at each procedure by estimation of mGy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'Prospective data collection of patients undergoing Atrial Fibrillation Ablation.', 'detailedDescription': 'Clinicians who have experience using low dose fluoroscopy including use of Carto Mapping system will consent patients to allow data collection and a 12 month f/up visit to track adverse events. Clinicians will follow a protocol which will be similar to their standard of care for ablations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have persistant or paroxysmal atrial fibrillation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient meets accepted AHA/ACC/HRS guideline indications for catheter ablation of paroxysmal or persistent AF\n* First or subsequent ablation procedures may be included\n* Age 18-75\n\nExclusion Criteria:\n\n* Known venous malformations or implanted instrumentation (IVC filter)\n* Known PV stenosis\n* Unable to provide consent\n* H/O mechanical mitral valve replacement (unable to rely on EA mapping only)\n* Documented left atrial thrombus\n* Prior ASD repair Pregnancy\n* NYHA \\>=3\n* EF less than 35%\n* CHF within 90 daysRecent MI or coronary revascularization within 90 days\n* NOTE: H/O implanted pacemaker or ICD with transvenous leads will NOT be an exclusion criteria, but we will track patients treated with pre-existing transvenous leads with the hypothesis that although fluoroscopy use will be higher in these patients compared to those without leads, but still lower than conventionally treated patients.\n* Patients who are undergoing non- standard of care ablations ie, Cyro or FIRM ablations'}, 'identificationModule': {'nctId': 'NCT02830750', 'briefTitle': 'Low Fluoroscopy Afib Ablation Registry', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'A Multi Center Registry of Low- Fluoroscopy Atrial Fibrillation Ablation Using Electroanatomic Mapping Carto', 'orgStudyIdInfo': {'id': '35821'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ablation', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '46601', 'city': 'South Bend', 'state': 'Indiana', 'country': 'United States', 'facility': 'Beacon Medical Group', 'geoPoint': {'lat': 41.68338, 'lon': -86.25001}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham's Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Chad Brodt, MD PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beacon Medical Group', 'class': 'UNKNOWN'}, {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, {'name': 'Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Direcetor of Clinical Resarch. CV Med', 'investigatorFullName': "Gerri O'Riordan", 'investigatorAffiliation': 'Stanford University'}}}}