Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-27 @ 4:58 AM
Study NCT ID:
NCT04079634
Status:
COMPLETED
Last Update Posted:
2023-05-16
First Post:
2019-09-03
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Esophageal Temperature Management During Cryo AF Ablation (EnsoETM)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-03-22', 'type': 'ACTUAL'}}}}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nishant.verma@nm.org', 'phone': '3129262148', 'title': 'Nishant Verma, MD', 'organization': 'Northwestern University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '3 months', 'description': 'Information on all adverse events will be recorded immediately in the source document, and also in the appropriate adverse event case report form (CRF). All clearly related signs, symptoms, and clinically significant abnormal diagnostic procedures results should be recorded in the source document. All adverse events occurring during the study period (consent through 3 month follow up) will be recorded.', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment', 'description': 'Placement of study device (EnsoETM) for temperature management\n\nEsophageal warming: Use of EnsoETM for esophageal warming to limit injury during atrial fibrillation ablation procedure', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Placement of standard temperature probe\n\nControl: Standard temperature probe monitoring', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Esophageal Thermal Injury', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Placement of study device (EnsoETM) for temperature management\n\nEsophageal warming: Use of EnsoETM for esophageal warming to limit injury during atrial fibrillation ablation procedure'}, {'id': 'OG001', 'title': 'Control', 'description': 'Placement of standard temperature probe\n\nControl: Standard temperature probe monitoring'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Post-Procedure Day 1', 'description': 'Endoscopic evidence of thermal injury', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment', 'description': 'Placement of study device (EnsoETM) for temperature management\n\nEsophageal warming: Use of EnsoETM for esophageal warming to limit injury during atrial fibrillation ablation procedure'}, {'id': 'FG001', 'title': 'Control', 'description': 'Placement of standard temperature probe\n\nControl: Standard temperature probe monitoring'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment', 'description': 'Placement of study device (EnsoETM) for temperature management\n\nEsophageal warming: Use of EnsoETM for esophageal warming to limit injury during atrial fibrillation ablation procedure'}, {'id': 'BG001', 'title': 'Control', 'description': 'Placement of standard temperature probe\n\nControl: Standard temperature probe monitoring'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '64.7', 'spread': '11.0', 'groupId': 'BG000'}, {'value': '66.6', 'spread': '8.4', 'groupId': 'BG001'}, {'value': '65.6', 'spread': '9.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Hypertension (HTN)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Diabetes', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Coronary Artery Disease (CAD)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Cerebrovascular Accident (CVA)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Paroxysmal Atrial Fibrillation (AF)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Persistent Atrial Fibrillation (AF)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-06-24', 'size': 342438, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-04-11T13:12', 'hasProtocol': True}, {'date': '2020-06-25', 'size': 225257, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-02-23T14:52', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participant will not be informed if they were randomized to control or treatment until Month 2 follow-up visit.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-24', 'studyFirstSubmitDate': '2019-09-03', 'resultsFirstSubmitDate': '2023-02-23', 'studyFirstSubmitQcDate': '2019-09-03', 'lastUpdatePostDateStruct': {'date': '2023-05-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-04-24', 'studyFirstPostDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Esophageal Thermal Injury', 'timeFrame': 'Post-Procedure Day 1', 'description': 'Endoscopic evidence of thermal injury'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'The purpose of this pilot study is to determine if esophageal warming using the Attune Medical Esophageal Heat Transfer Device (EnsoETM) limits the frequency or severity of thermal injury during cryoballoon ablation of atrial fibrillation.', 'detailedDescription': 'Catheter ablation of atrial fibrillation (AF) has become a common ablation procedure performed worldwide. The cornerstone of this procedure is pulmonary vein isolation (PVI). PVI can be achieved by multiple methods, the two most common being radiofrequency (RF) and cryoablation. Energy delivery may extend beyond the atrial myocardium and result in damage to adjacent structures, including the esophagus. Atrio-esophageal fistula (AEF) is a rare, but a well-recognized complication of percutaneous AF ablation. The occurrence rate of esophageal injury has varied depending on the reporting center, timing of endoscopy, and the ablation technique utilized. Esophageal ulceration is likely the initial injury that leads to AEF formation and is probably present within hours to days of the ablation procedure.\n\nThe Attune Medical Esophageal Heat Transfer Device (EnsoETM) is a non-sterile, multi-lumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while simultaneously allowing gastric decompression and drainage. For this study, the EnsoETM tube will be used during cardiac ablation procedures for the intended indication of patient temperature management using approved settings/parameters as detailed in the product instructions for use document. EnsoETM is an FDA approved device.\n\nThis prospective, randomized study will include 40 patients with symptomatic AF undergoing index PVI under general anesthesia at Northwestern Memorial Hospital. Patients will be randomized in a 1:1 fashion with 20 patients (Group A) randomized to undergo the ablation procedure with esophageal warming and the other 20 patients (Group B) will serve as the control group and will not have the EnsoETM device used. All patients will undergo esophagogastroduodenoscopy (EGD) 1-2 days following the ablation procedure to evaluate for esophageal injury.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients above the age of 18 years old.\n2. Patients with the diagnosis of atrial fibrillation undergoing clinically indicated de-novo AF ablation procedure.\n3. Patients must be willing to provide informed consent.\n\nExclusion Criteria:\n\n1. Patients with contraindication to EGD.\n2. History of prior AF ablation procedures.\n3. Significant co-morbidities that preclude standard ablation procedure.\n4. Patient is ineligible for EnsoETM placement due to:\n\n * Known esophageal deformity or evidence of esophageal trauma (for example history of esophagectomy, previous swallowing disorders, achalasia).\n * Known ingestion of acidic or caustic poisons within the prior 24 hours.\n * Patients with \\<40 kg of body mass.'}, 'identificationModule': {'nctId': 'NCT04079634', 'acronym': 'EnsoETM', 'briefTitle': 'Esophageal Temperature Management During Cryo AF Ablation (EnsoETM)', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Esophageal Temperature Management During Cryo AF Ablation', 'orgStudyIdInfo': {'id': 'STU00209610'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Placement of study device (EnsoETM) for temperature management', 'interventionNames': ['Device: Esophageal warming']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Placement of standard temperature probe', 'interventionNames': ['Device: Control']}], 'interventions': [{'name': 'Esophageal warming', 'type': 'DEVICE', 'description': 'Use of EnsoETM for esophageal warming to limit injury during atrial fibrillation ablation procedure', 'armGroupLabels': ['Treatment']}, {'name': 'Control', 'type': 'DEVICE', 'description': 'Standard temperature probe monitoring', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Nishant Verma, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['ICF'], 'timeFrame': 'Within one year of enrollment closure', 'ipdSharing': 'YES', 'accessCriteria': 'Consent will be posted to ClinicalTrials.Gov'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Attune Medical', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine', 'investigatorFullName': 'Nishant Verma', 'investigatorAffiliation': 'Northwestern University'}}}}