Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:17 PM
Study NCT ID:
NCT05709756
Status:
COMPLETED
Last Update Posted:
2023-10-02
First Post:
2023-01-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevalence and Predictors of Esophageal Thermal Lesions in High-power-Short-duration Ablation of Atrial Fibrillation
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': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 263}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-29', 'studyFirstSubmitDate': '2023-01-24', 'studyFirstSubmitQcDate': '2023-01-24', 'lastUpdatePostDateStruct': {'date': '2023-10-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of ablation-related esophageal thermal lesions', 'timeFrame': 'One day after Catheter ablation', 'description': 'It will be assessed by means of Esophagoscopy'}], 'secondaryOutcomes': [{'measure': 'Size of ablation-related esophageal thermal lesions', 'timeFrame': 'One day after Catheter ablation', 'description': 'It will be assessed by means of Esophagoscopy'}, {'measure': 'Severity of ablation-related esophageal thermal lesions', 'timeFrame': 'One day after Catheter ablation', 'description': 'It will be assessed by means of Esophagoscopy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Atrial Fibrillation', 'Esophagus Injury', 'Pulmonary vein isolation', 'Esophagoscopy'], 'conditions': ['Esophagus Injury', 'Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '38646922', 'type': 'DERIVED', 'citation': 'Wolff C, Langenhan K, Wolff M, Efimova E, Zachaus M, Darma A, Dinov B, Seewoster T, Nedios S, Bertagnolli L, Wolff J, Paetsch I, Jahnke C, Bollmann A, Hindricks G, Bode K, Halm U, Arya A. Incidence and predictors of thermal oesophageal and vagus nerve injuries in Ablation Index-guided high-power-short-duration ablation of atrial fibrillation: a prospective study. Europace. 2024 May 2;26(5):euae107. doi: 10.1093/europace/euae107.'}]}, 'descriptionModule': {'briefSummary': 'Patients with documented atrial fibrillation who were referred to our clinic for catheter ablation will undergo standard HPSD ablation and subsequent esophagoscopy.\n\nAfter esophagoscopy patients will be followed up for one month in the form of a telephone follow-up.\n\nThe primary endpoint of the study assessed by esophagoscopy performed on the day after the index catheter ablaton is the incidence of esophageal thermal lesions.\n\nSecondary endpoints include:\n\n1. The size of the esophageal thermal lesions.\n2. The severity of esophageal thermal lesions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with documented atrial fibrillation who were referred to our clinic for pulomary vein isolation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Atrial fibrillation documented in the 12-lead ECG\n* Indication for catheter ablation in accordance with currentn ESC guidelines\n\nExclusion Criteria:\n\n* Pregnancy\n* Women of childbearing potential without a negative pregnancy test within 48 hours prior to ablation procedure\n* Known intracardiac or other thrombi\n* Contraindication to anticoagulation\n* Contraindication to esophagoscopy: diseases and deformities of the cervical spine, esophageal varices'}, 'identificationModule': {'nctId': 'NCT05709756', 'acronym': 'VISUAL-AF', 'briefTitle': 'Prevalence and Predictors of Esophageal Thermal Lesions in High-power-Short-duration Ablation of Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'Helios Health Institute GmbH'}, 'officialTitle': 'Prevalence and Predictors of Esophageal Thermal Lesions in High-Power-Short-Duration Ablation of Atrial Fibrillation', 'orgStudyIdInfo': {'id': '549/20-ek'}}, 'contactsLocationsModule': {'locations': [{'zip': '04289', 'city': 'Leipzig', 'state': 'Saxony', 'country': 'Germany', 'facility': 'Arash Arya', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '04289', 'city': 'Leipzig', 'state': 'Saxony', 'country': 'Germany', 'facility': 'Department of Electrophysiology, Leipzig Heart Center at University of Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}], 'overallOfficials': [{'name': 'Gerhard Hindricks, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Leipzig Heart Center at University of Leipzig'}, {'name': 'Arash Arya, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Leipzig Heart Center at University of Leipzig'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helios Health Institute GmbH', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}