Ignite Creation Date:
2025-12-24 @ 12:06 PM
Ignite Modification Date:
2025-12-27 @ 10:06 PM
Study NCT ID:
NCT04063761
Status:
COMPLETED
Last Update Posted:
2025-06-17
First Post:
2019-08-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluating Active Esophageal Cooling During Cardiac Ablation Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-08-16', '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': 'info@attune-medical.com', 'phone': '888.534.4873', 'title': 'Clinical Research Coordinator', 'organization': 'Attune Medical'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '24 hours', 'eventGroups': [{'id': 'EG000', 'title': 'Esophageal Cooling', 'description': 'Single arm study: Patients receive the Attune Medical Esophageal Heat Transfer Device\n\nesophageal cooling device (Attune Medical, Chicago, IL): Prospective, single center pilot study', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Time of Active Ablation Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Esophageal Cooling', 'description': 'Single arm study: Patients receive the Attune Medical Esophageal Heat Transfer Device\n\nesophageal cooling device (Attune Medical, Chicago, IL): Prospective, single center pilot study'}], 'classes': [{'categories': [{'measurements': [{'value': '3.26', 'spread': '0.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Study Day 1 for all patients enrolled, during left atrial ablation procedures using radiofrequency energy, up to 5 hours', 'description': 'Study Day 1 for all patients enrolled, during left atrial ablation procedures using radiofrequency energy, up to 5 hours. Measured as total procedure time as documented by clinician recorder and research coordinator.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Procedure Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Esophageal Cooling', 'description': 'Single arm study: Patients receive the Attune Medical Esophageal Heat Transfer Device\n\nesophageal cooling device (Attune Medical, Chicago, IL): Prospective, single center pilot study'}], 'classes': [{'categories': [{'measurements': [{'value': '5.11', 'spread': '0.59', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Study Day 1 for all patients enrolled from patient entry to Electrophysiology (EP) lab until post procedure discharge to Post-Anesthesia Care Unit (PACU)', 'description': 'Study Day 1 for all patients enrolled, during left atrial ablation procedures using radiofrequency energy, up to 5 hours after procedure. Measured as total procedure time to discharge to PACU as documented by clinician recorder and research coordinator.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Procedural Pauses During Left Atrial Instrumentation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Esophageal Cooling', 'description': 'Single arm study: Patients receive the Attune Medical Esophageal Heat Transfer Device\n\nesophageal cooling device (Attune Medical, Chicago, IL): Prospective, single center pilot study'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '.168'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Study Day 1 for all patients enrolled, during left atrial ablation procedures using radiofrequency energy, up to 5 hours', 'description': 'Number of procedural pauses during left atrial instrumentation measured from trans-septal puncture to achievement of Pulmonary Vein Isolation (PVI)', 'unitOfMeasure': 'Procedural pauses', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Esophageal Cooling', 'description': 'Single arm study: Patients receive the Attune Medical Esophageal Heat Transfer Device\n\nesophageal cooling device (Attune Medical, Chicago, IL): Prospective, single center pilot study'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Esophageal Cooling', 'description': 'Single arm study: Patients receive the Attune Medical Esophageal Heat Transfer Device\n\nesophageal cooling device (Attune Medical, Chicago, IL): Prospective, single center pilot study'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '66', 'spread': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], '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': '20', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-03-30', 'size': 615577, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-07-20T13:22', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2021-02-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-12', 'studyFirstSubmitDate': '2019-08-19', 'resultsFirstSubmitDate': '2022-07-20', 'studyFirstSubmitQcDate': '2019-08-20', 'lastUpdatePostDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-08-15', 'studyFirstPostDateStruct': {'date': '2019-08-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Time of Active Ablation Procedure', 'timeFrame': 'Study Day 1 for all patients enrolled, during left atrial ablation procedures using radiofrequency energy, up to 5 hours', 'description': 'Study Day 1 for all patients enrolled, during left atrial ablation procedures using radiofrequency energy, up to 5 hours. Measured as total procedure time as documented by clinician recorder and research coordinator.'}], 'secondaryOutcomes': [{'measure': 'Total Procedure Time', 'timeFrame': 'Study Day 1 for all patients enrolled from patient entry to Electrophysiology (EP) lab until post procedure discharge to Post-Anesthesia Care Unit (PACU)', 'description': 'Study Day 1 for all patients enrolled, during left atrial ablation procedures using radiofrequency energy, up to 5 hours after procedure. Measured as total procedure time to discharge to PACU as documented by clinician recorder and research coordinator.'}, {'measure': 'Number of Procedural Pauses During Left Atrial Instrumentation', 'timeFrame': 'Study Day 1 for all patients enrolled, during left atrial ablation procedures using radiofrequency energy, up to 5 hours', 'description': 'Number of procedural pauses during left atrial instrumentation measured from trans-septal puncture to achievement of Pulmonary Vein Isolation (PVI)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'Left atrial catheter ablation including pulmonary vein isolation is a standard therapy in the management of symptomatic atrial fibrillation; however thermal esophageal injury is a known potential consequence of this procedure. Delivery of radiofrequency (RF) energy necessary to perform left atrial ablation has the potential to cause injury to the nearby esophagus including ulceration, hematoma, spasm, esophageal motility disorders, and, in the most extreme case, atrial-esophageal fistula (AEF). Esophageal mucosal lesions are the likely precursor to AEF, and esophageal mucosal lesions have been detected on post-ablation endoscopy after pulmonary vein isolation with an incidence ranging from 3% to 60%.\n\nActive esophageal cooling during RF ablation as a means of esophageal injury prevention has been investigated through mathematical models, pre-clinical studies, and in clinical trials. Existing data support the efficacy of this approach, but the practice has not been widely adopted due to lack of a commercially available device.\n\nThe aim or purpose of this study is to evaluate the impact on procedural efficiency of ablation procedures performed using esophageal heat transfer to cool the esophagus during left atrial RF ablation.', 'detailedDescription': 'This study is a prospective, pilot study using the Attune Medical esophageal heat transfer device to actively cool the esophagus during RF ablation procedures. This design is appropriate to gather the data needed regarding overall procedural time, compare this to historical controls, and estimate a sample size for a larger study powered for statistical significance.\n\nThe subjects will undergo preparation and anesthesia procedures following standard practice. Once the patient is intubated, the esophageal heat transfer device will be placed into the esophagus according to the Instructions for Use (IFU). The device will remain in place until the ablation procedure is completed and will be removed before extubation. Posterior left atrial wall ablation using standard parameters will only be performed when the esophageal heat transfer device has reached a temperature of 4-6 degrees C for at least 2 minutes. The device will be set to neutral or warming temperature (37-42 degrees C) during other aspects of the procedure (such as mapping and anterior wall ablations).\n\nAll patients will be followed up in total for 6 weeks (Long Term Follow-up visit) after the procedure to document any clinical complication related to thermal esophageal injuries if applicable.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (age over 18 years)\n* Undergoing first left atrial ablation for the treatment of atrial fibrillation (AF) including pulmonary vein isolation\n* Undergoing catheter-based ablation procedure using radiofrequency energy\n* Patients must be able to understand and critically review the informed consent form.\n* Subjects must understand and agree to study requirements and sign a written informed consent.\n\nExclusion Criteria:\n\n* Patients who are unable to provide informed consent.\n* History of prior atrial fibrillation (AF) ablation procedures.\n* Significant co-morbidities that preclude standard ablation procedure.\n* Patients with \\<40 kg of body mass\n* Patients with relevant esophageal pathology (e.g. esophageal cancer)'}, 'identificationModule': {'nctId': 'NCT04063761', 'briefTitle': 'Evaluating Active Esophageal Cooling During Cardiac Ablation Procedures', 'organization': {'class': 'INDUSTRY', 'fullName': 'Advanced Cooling Therapy LLC, d/b/a Attune Medical'}, 'officialTitle': 'Evaluating Active Esophageal Cooling During Cardiac Ablation Procedures', 'orgStudyIdInfo': {'id': 'AMEVAB2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Esophageal Cooling', 'description': 'Single arm study: Patients receive the Attune Medical Esophageal Heat Transfer Device', 'interventionNames': ['Device: esophageal cooling device (Attune Medical, Chicago, IL)']}], 'interventions': [{'name': 'esophageal cooling device (Attune Medical, Chicago, IL)', 'type': 'DEVICE', 'description': 'Prospective, single center pilot study', 'armGroupLabels': ['Esophageal Cooling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}], 'overallOfficials': [{'name': 'Alexander Mazur, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Iowa'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Advanced Cooling Therapy, Inc., d/b/a Attune Medical', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Iowa', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}