Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2026-02-25 @ 8:49 PM
Study NCT ID:
NCT01520532
Status:
COMPLETED
Last Update Posted:
2018-10-16
First Post:
2012-01-25
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of the Incidence of Cerebral Lesions Post Pulmonary Vein Ablation Catheter (PVAC)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jay.l.kelley@medtronic.com', 'phone': '+1.760.827.0076', 'title': 'Jay Kelley, Director of Clinical Research', 'organization': 'Medtronic AF Solutions'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Ablation', 'otherNumAtRisk': 60, 'otherNumAffected': 11, 'seriousNumAtRisk': 60, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Groin Bleed', 'notes': 'Mild groin bleed at location of sheath insertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Bleeding', 'notes': 'Groin bleed requiring intervention (thrombin administration)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "New Asymptomatic Cerebral Embolic Lesions, Visualized as 'Bright Spots' on Post-ablation MRI.", 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ablation'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 1-3 days post ablation', 'description': 'An acute embolic lesion is defined as a focal hyper-intense area detected on the diffusion-weighted (DW) sequence, corresponding to a hyper-intense signal intensity in the fluid-attenuated inversion recovery (FLAIR) sequence, and also confirmed by apparent diffusion coefficient (ADC) mapping to rule out a shine-through artifact.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subject who underwent an ablation and post-procedure MRI.'}, {'type': 'SECONDARY', 'title': 'Acute Safety Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ablation'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'Assess the number of procedure or device-related serious adverse events when applying best practices with PVAC.', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who underwent an ablation and post-procedure MRI'}, {'type': 'SECONDARY', 'title': 'Acute Efficacy, as Determined by Complete Pulmonary Vein Isolation (PVI) Per Subject.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ablation'}], 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 (End of Procedure)', 'description': 'The number of subjects with pulmonary vein isolation (PVI) at the end of ablation procedure. This will characterize if use of best practices during PVAC ablation negatively affects acute efficacy.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who underwent ablation and post-procedure MRI.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ablation', 'description': 'Single-arm study, all subjects received a radio-frequency (RF) ablation with the goal of achieving Pulmonary Vein Isolation (PVI).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Subjects who underwent an ablation and had post-procedure MRI', 'groupId': 'FG000', 'numSubjects': '60'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Ablation'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60', 'spread': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '41', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-17', 'studyFirstSubmitDate': '2012-01-25', 'resultsFirstSubmitDate': '2012-12-10', 'studyFirstSubmitQcDate': '2012-01-27', 'lastUpdatePostDateStruct': {'date': '2018-10-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-02-12', 'studyFirstPostDateStruct': {'date': '2012-01-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-03-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "New Asymptomatic Cerebral Embolic Lesions, Visualized as 'Bright Spots' on Post-ablation MRI.", 'timeFrame': 'Within 1-3 days post ablation', 'description': 'An acute embolic lesion is defined as a focal hyper-intense area detected on the diffusion-weighted (DW) sequence, corresponding to a hyper-intense signal intensity in the fluid-attenuated inversion recovery (FLAIR) sequence, and also confirmed by apparent diffusion coefficient (ADC) mapping to rule out a shine-through artifact.'}], 'secondaryOutcomes': [{'measure': 'Acute Safety Events', 'timeFrame': '30 days', 'description': 'Assess the number of procedure or device-related serious adverse events when applying best practices with PVAC.'}, {'measure': 'Acute Efficacy, as Determined by Complete Pulmonary Vein Isolation (PVI) Per Subject.', 'timeFrame': 'Day 1 (End of Procedure)', 'description': 'The number of subjects with pulmonary vein isolation (PVI) at the end of ablation procedure. This will characterize if use of best practices during PVAC ablation negatively affects acute efficacy.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '23983245', 'type': 'RESULT', 'citation': 'Verma A, Debruyne P, Nardi S, Deneke T, DeGreef Y, Spitzer S, Balzer JO, Boersma L; ERACE Investigators. Evaluation and reduction of asymptomatic cerebral embolism in ablation of atrial fibrillation, but high prevalence of chronic silent infarction: results of the evaluation of reduction of asymptomatic cerebral embolism trial. Circ Arrhythm Electrophysiol. 2013 Oct;6(5):835-42. doi: 10.1161/CIRCEP.113.000612. Epub 2013 Aug 27.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine the rate of diffusion weighted (DW)-MRI cerebral lesions following a Pulmonary Vein Ablation Catheter (PVAC) ablation procedure performed using best practices, including optimized procedural techniques and anti-coagulation therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject is at least 18 years old\n* Subject has been diagnosed with atrial fibrillation (AF)\n* Subject is indicated for a pulmonary vein ablation using PVAC\n* Subject (or subject's legally authorized representative) is able and and willing to give informed consent.\n\nExclusion Criteria:\n\n* Subject has permanent AF\n* Subject has a left atrial thrombus detected on TEE\n* Subject has had a prior left atrial ablation\n* Subject has a intracardiac thrombus\n* Subject is contraindicated for Warfarin (Coumadin)\n* Subject has a cardiac valve prosthesis\n* Subject has a significant congenital heart defect corrected or not including atrial septal defects or pulmonary vein abnormalities but not including minor PFO)\n* Subject has presence of any pulmonary vein stents\n* Subject has presence of any pre-existing pulmonary vein stenosis\n* Subject has had a cerebral ischemic event (strokes or transient ischemic attacks \\[TIA\\]) which occurred during the 6 month interval preceding the Consent Date\n* Subject is a woman known to be pregnant\n* Subject is unwilling or unable to comply fully with study procedures and follow-up"}, 'identificationModule': {'nctId': 'NCT01520532', 'acronym': 'ERACE', 'briefTitle': 'Evaluation of the Incidence of Cerebral Lesions Post Pulmonary Vein Ablation Catheter (PVAC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Cardiac Rhythm and Heart Failure'}, 'officialTitle': 'Evaluate Reduction in Asymptomatic Cerebral Embolism', 'orgStudyIdInfo': {'id': 'MDT-AFS-ERACE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Ablation', 'interventionNames': ['Other: Magnetic Resonance Imaging (MRI)']}], 'interventions': [{'name': 'Magnetic Resonance Imaging (MRI)', 'type': 'OTHER', 'description': "MRI's will be performed on all subjects at Enrollment and Pre-Discharge (Post Ablation). Subjects with a positive MRI (cerebral lesion) at the Pre-Discharge will undergo an MRI at the 1 month follow-up visit.", 'armGroupLabels': ['Ablation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Antwerp', 'country': 'Belgium', 'facility': 'AZ Middelheim', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'city': 'Bonheiden', 'country': 'Belgium', 'facility': 'Imelda Ziekenhuis', 'geoPoint': {'lat': 51.02261, 'lon': 4.54714}}, {'zip': 'L3Y 2P9', 'city': 'Newmarket', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Southlake Regional Health Center', 'geoPoint': {'lat': 44.05011, 'lon': -79.46631}}, {'city': 'Bad Neustadt/Saale', 'country': 'Germany', 'facility': 'Herz- und Gefäß-Klinik'}, {'city': 'Dresden', 'country': 'Germany', 'facility': 'Praxisklinik - Herz- und Gefässe', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'city': 'Castel Volturno', 'country': 'Italy', 'facility': 'Clinica Pineta Grande', 'geoPoint': {'lat': 41.03288, 'lon': 13.94354}}, {'city': 'Nieuwegein', 'country': 'Netherlands', 'facility': 'AZ Sint Antonius Ziekenhuis', 'geoPoint': {'lat': 52.02917, 'lon': 5.08056}}], 'overallOfficials': [{'name': 'Yves De Greef, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AZ Middelheim'}, {'name': 'Lucas Boersma, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AZ Sint Antonius Ziekenhuis'}, {'name': 'Thomas Deneke, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Krankenhaus Porz am Rheim'}, {'name': 'Stefano Nardi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pineta Grande Hospital'}, {'name': 'Atul Verma, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Southlake Regional health Center'}, {'name': 'Stefan G Spitzer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Praxisklinik Herz- und Gefässe'}, {'name': 'Philippe Debruyne, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imelda Hospital, Bonheiden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Cardiac Rhythm and Heart Failure', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}