Ignite Creation Date:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2026-02-24 @ 10:46 AM
Study NCT ID:
NCT01546168
Status:
TERMINATED
Last Update Posted:
2018-01-23
First Post:
2012-02-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Deviating the Esophagus in Atrial Fibrillation Ablation
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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'vivek.reddy@mountsinai.org', 'phone': '212-241-7114', 'title': 'Dr. Vivek Y Reddy', 'organization': 'Icahn School of Medicine at Mount Sinai'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'description': '17 roll-in patients and two pre-procedure withdrawals are removed from the analysis.', 'eventGroups': [{'id': 'EG000', 'title': 'Esophageal Deviation', 'description': 'esophageal deviation with IDE device during AF ablation', 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 7, 'seriousNumAtRisk': 36, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Temperature Monitoring', 'description': 'luminal esophageal standing temperature monitoring alone', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 4, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Atrial Flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Groin Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Nausea with abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Venous Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Acute Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Pericardial Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 2}], 'organSystem': 'Cardiac disorders'}, {'term': 'Asthma Exacerbation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Presence of Esophageal Injury', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esophageal Deviation', 'description': 'esophageal deviation with IDE device during AF ablation'}, {'id': 'OG001', 'title': 'Temperature Monitoring', 'description': 'luminal esophageal standing temperature monitoring alone'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'within 1 week of AF ablation procedure', 'description': 'The presence of esophageal injury as assessed by upper gastrointestinal endoscopy that is performed within 1 week of the procedure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '17 roll-in patients and two pre-procedure withdrawals are removed from the analysis.'}, {'type': 'SECONDARY', 'title': 'Procedure Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esophageal Deviation', 'description': 'esophageal deviation with IDE device during AF ablation'}, {'id': 'OG001', 'title': 'Temperature Monitoring', 'description': 'luminal esophageal standing temperature monitoring alone'}], 'classes': [{'title': 'Fluoroscopy time', 'categories': [{'measurements': [{'value': '21.1', 'spread': '9.9', 'groupId': 'OG000'}, {'value': '20.9', 'spread': '18.3', 'groupId': 'OG001'}]}]}, {'title': 'Procedure duration', 'categories': [{'measurements': [{'value': '3.39', 'spread': '1.00', 'groupId': 'OG000'}, {'value': '4.11', 'spread': '1.07', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 1, duration ofAF ablation procedure', 'description': 'Procedure time and fluoroscopic imaging with barium contrast time', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '17 roll-in patients and two pre-procedure withdrawals are removed from the analysis.'}, {'type': 'SECONDARY', 'title': 'Temperature', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esophageal Deviation', 'description': 'esophageal deviation with IDE device during AF ablation'}, {'id': 'OG001', 'title': 'Temperature Monitoring', 'description': 'luminal esophageal standing temperature monitoring alone'}], 'classes': [{'categories': [{'measurements': [{'value': '0.26', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '0.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'during AF ablation procedure (intraoperative)', 'description': 'Extent of temperature rise on the temperature monitoring probe', 'unitOfMeasure': 'Celsius', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '17 roll-in patients and two pre-procedure withdrawals are removed from the analysis.'}, {'type': 'SECONDARY', 'title': 'Swallowing Impairment Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esophageal Deviation', 'description': 'esophageal deviation with IDE device during AF ablation'}, {'id': 'OG001', 'title': 'Temperature Monitoring', 'description': 'luminal esophageal standing temperature monitoring alone'}], 'classes': [{'categories': [{'measurements': [{'value': '0.67', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '0.27', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'during AF ablation procedure (intraoperative)', 'description': 'Swallowing impairment during procedure - Scale from 0 (no impairment) to 4 (severe impairment).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '17 roll-in patients and two pre-procedure withdrawals are removed from the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Esophageal Deviation', 'description': 'esophageal deviation with IDE device during AF ablation'}, {'id': 'FG001', 'title': 'Temperature Monitoring', 'description': 'luminal esophageal standing temperature monitoring alone'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'ineligible after signing consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment began in November 2011, with enrollment beginning February 2012', 'preAssignmentDetails': '88 participants were consented, but 2 withdrew prior to randomization'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Esophageal Deviation', 'description': 'esophageal deviation with IDE device during AF ablation'}, {'id': 'BG001', 'title': 'Temperature Monitoring', 'description': 'luminal esophageal standing temperature monitoring alone'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.8', 'spread': '8.3', 'groupId': 'BG000'}, {'value': '62.6', 'spread': '8.6', 'groupId': 'BG001'}, {'value': '61.7', 'spread': '8.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Persistent AF', 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Paroxysmal AF', 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'CHADS Score', 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'spread': '0.8', 'groupId': 'BG000'}, {'value': '1', 'spread': '0.9', 'groupId': 'BG001'}, {'value': '0.83', 'spread': '0.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'CHADS score for Stroke Risk Assessment in Atrial Fibrillation CHADS is a mnemonic for Congestive Heart Failure, Hypertension, Age over 75 years, Diabetes Mellitus, and Stroke or TIA history CHADS Score \\>2 (CVA risk \\>5% per year) CHADS Score 1 (CVA risk \\>4% per year) CHADS Score 0 (low risk)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'History of GERD', 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': '17 roll-in patients and two pre-procedure withdrawals are removed from the analysis'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'whyStopped': 'Interim analysis: no statistically significant difference in the 2 study arms.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-19', 'studyFirstSubmitDate': '2012-02-13', 'resultsFirstSubmitDate': '2017-04-17', 'studyFirstSubmitQcDate': '2012-03-01', 'lastUpdatePostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-01-19', 'studyFirstPostDateStruct': {'date': '2012-03-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Presence of Esophageal Injury', 'timeFrame': 'within 1 week of AF ablation procedure', 'description': 'The presence of esophageal injury as assessed by upper gastrointestinal endoscopy that is performed within 1 week of the procedure.'}], 'secondaryOutcomes': [{'measure': 'Procedure Time', 'timeFrame': 'day 1, duration ofAF ablation procedure', 'description': 'Procedure time and fluoroscopic imaging with barium contrast time'}, {'measure': 'Temperature', 'timeFrame': 'during AF ablation procedure (intraoperative)', 'description': 'Extent of temperature rise on the temperature monitoring probe'}, {'measure': 'Swallowing Impairment Score', 'timeFrame': 'during AF ablation procedure (intraoperative)', 'description': 'Swallowing impairment during procedure - Scale from 0 (no impairment) to 4 (severe impairment).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Atrial Fibrillation ablation', 'Esophageal Deviation', 'AF'], 'conditions': ['Esophageal Deviation', 'Atrial Fibrillation', 'Ablation']}, 'descriptionModule': {'briefSummary': 'In this randomized double-blind study, the investigators would like to compare standard practice (i.e., use of luminal esophageal temperature monitoring) to that of esophageal deviation during AF ablation. The investigators hypothesize that the strategy of esophageal deviation will result in safer ablation strategy with a reduction in the incidence of esophageal injury as assessed by endoscopy.', 'detailedDescription': 'Catheter ablation is a commonly performed strategy employed for the treatment of atrial fibrillation. However ablation in the posterior wall of the left atrium can cause thermal injury to the esophagus. When significant thermal injury to the esophagus occurs, two significant complications can occur: 1) the formation of an atrio-esophageal fistula, and 2) gastrointestinal dysmotility. While the former is rate, it is an important complication since it can be fatal. The frequency of the latter complication is less well appreciated, but probably occurs in the range of 1:100 to 1:500. Currently luminal esophageal temperature monitoring is the most commonly employed modality to prevent such injury. However, there are limitations to its use, and atrio-esophageal fistulas have been reported even when using esophageal temperature monitoring. Esophageal deviation using either a TEE or EGD probe has been described in the literature, but the effectiveness and practicality of these techniques are suboptimal, and have therefore precluded their use in routine clinical practice. Recently, we have demonstrated that esophageal deviation is indeed possible using off-the-shelf equipment (a soft thoracic tube and endotracheal stylet) in patients undergoing AF ablation. In this randomized double-blind study, we will compare standard practice (i.e., use of luminal esophageal temperature monitoring) to esophageal deviation during AF ablation. We hypothesize that the strategy of esophageal deviation will result in safer ablation strategy with a reduction in the incidence of esophageal injury as assessed by endoscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18 - Age \\< 80 yr\n* Documentation of atrial fibrillation (AF)\n* Referred for a first ever ablation procedure for AF (prior ablation of right-sided Typical flutter, or "limited" left-sided of an accessory pathway are permitted)\n* General anesthesia\n* All patients must understand and adhere to the requirements of the study and be willing to comply with the post study follow-up requirements.\n\nExclusion Criteria:\n\n* Any reversible cause of AF (post-surgery, thyroid disorder, etc.)\n* INR \\> 4.0 at the time of the procedure\n* H/o of severe esophageal ulcers, strictures, esophagitis or GERD\n* H/o Esophageal Surgery\n* Prior surgical or catheter ablation procedure for AF (except right atrial flutter ablation)\n* Any evidence of esophageal diverticulum or other structural abnormalities of the esophagus seen during baseline barium esophagogram\n* Significant abnormality on Swallowing Impairment Score\n* Mental impairment precluding signing consent or completing follow up\n* Patients with any other significant uncontrolled or unstable medical condition\n* Women who are known to be pregnant or have had a positive β-HCG test 7 days prior to procedure'}, 'identificationModule': {'nctId': 'NCT01546168', 'briefTitle': 'Deviating the Esophagus in Atrial Fibrillation Ablation', 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'Esophageal Deviation in Atrial Fibrillation Ablation: A Randomized Control Trial', 'orgStudyIdInfo': {'id': 'GCO 11-0909'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'esophageal deviation', 'description': 'esophageal deviation with IDE device during AF ablation', 'interventionNames': ['Device: esophageal deviation with IDE device']}, {'type': 'NO_INTERVENTION', 'label': 'temperature monitoring', 'description': 'luminal esophageal temperature monitoring, standard temperature monitoring alone'}], 'interventions': [{'name': 'esophageal deviation with IDE device', 'type': 'DEVICE', 'description': 'esophageal deviation during AF ablation', 'armGroupLabels': ['esophageal deviation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Hospital', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '78075', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Cardiac Arrhythmia Institute', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'Vivek Reddy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vivek Reddy', 'class': 'OTHER'}, 'collaborators': [{'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director Cardiac Arrhythmia Service, Professor of Medicine', 'investigatorFullName': 'Vivek Reddy', 'investigatorAffiliation': 'Icahn School of Medicine at Mount Sinai'}}}}