Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2026-01-01 @ 6:07 AM
Study NCT ID:
NCT05758805
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2023-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Esophageal Injury of a Tip CF Sensing Ablation Catheter for HP-SD of Paroxysmal and Persistent AF (ESO-SAFE-HP-RF)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D004939', 'term': 'Esophageal Perforation'}, {'id': 'D004937', 'term': 'Esophageal Fistula'}], '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'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D016154', 'term': 'Digestive System Fistula'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Pilot, about the safety, prospective, monocentric'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 51}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-07', 'studyFirstSubmitDate': '2023-02-21', 'studyFirstSubmitQcDate': '2023-03-06', 'lastUpdatePostDateStruct': {'date': '2024-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of the acute esophageal thermal injury (ETI)', 'timeFrame': '1-3 days after AF ablation procedure', 'description': 'Evaluate the acute proportion of the esophageal thermal injury (ETI)'}], 'secondaryOutcomes': [{'measure': 'Factors influencing RF procedure on ETI development', 'timeFrame': '1-3 days after AF ablation procedure', 'description': 'Contribution of the factors influencing RF procedure (contact force, impedance, RF power, RF time) on ETI development'}, {'measure': 'Esophageal temperature by an esophageal continuous monitoring device', 'timeFrame': 'during AF ablation procedure', 'description': 'Celsius degree.'}, {'measure': 'ETI monitoring', 'timeFrame': '12 months after AF ablation procedure', 'description': 'Chronic (every 3 months until healing) evaluation of discovered ETI.'}, {'measure': 'AF ablation procedure times', 'timeFrame': '1 day', 'description': 'minutes'}, {'measure': 'AF recurrences', 'timeFrame': '12 months after AF ablation procedure', 'description': 'AF recurrences until 12 months after the ablation procedure'}, {'measure': 'Serious and no serious adverse events', 'timeFrame': '12 months after AF ablation procedure', 'description': 'Serious and no serious adverse events after the ablation procedure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['esophageal thermal injury (ETI)', 'AF ablation', 'high-power, short-duration (HP-SD)', 'mini-invasive esophagoscopy'], 'conditions': ['Atrial Fibrillation', 'Esophageal Perforation', 'Esophageal Fistula']}, 'descriptionModule': {'briefSummary': 'This pilot, prospective, interventional, monocentric, independent, and no-profit clinical trial aims to investigate and evaluate the proportion, acute and chronic characteristics, and outcomes of esophageal thermal injury (ETI) in AF ablation using a high-power, short-duration (HP-SD) setting with contact force (CF) sensing tip ablation catheter in standard clinical practice. The main questions it aims to answer are:\n\n* Evaluate the acute proportion of the ETI assessed by the mini-invasive esophagoscopy pre and post-procedure. In addition, clinical evaluations at 3, 6, and 12 months from the procedure are foreseen.\n* Evaluate the contribution of the factors influencing RF procedure (contact force, impedance, RF power, RF time) on ETI development.\n* Describe the relationship between the esophageal temperature (continuous monitoring) and ETI development.', 'detailedDescription': 'This study aims to estimate the proportion of esophageal thermal injury (ETI) as a result of the AF ablation using a high-power, short-duration (HP-SD) setting with contact force (CF) sensing tip ablation catheter immediately after and at 3, 6, and 12 months from the procedure, as well as describe their characteristics.\n\nTo be more sensitive and specific in detecting the presence of potentially chronic and progressing ETIs in esophageal ulcers and atrium-esophageal fistula, a minimally invasive esophagogastroscope will be used before (1-7 days) and after (1-3 days) the ablation procedure, with an internal comparison of the lesions observed. In addition, various clinical characteristics of the patients and descriptors of the ablation procedure (such as contact force, impedance, RF power, RF time, esophageal temperature, procedure times, etc.) will be collected and related to the presence of ETI.\n\nThe principal Medical Devices that will be used:\n\n1. Cardiac Mapping system Ensite X (Abbott Medical),\n2. Tip CF sensing catheter TactiFlex (Abbott Medical),\n3. High mapping density catheter (HD GRID/Advisor FL, Abbott Medical),\n4. Continuous temperature monitoring devices (Esotest Multi/Esotherm 7 poles, FIAB),\n5. Video-endoscope EXERA III HDTV dual focus GIF-HQ190 (Olympus).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Atrial fibrillation and, according to current guidelines, indication for radiofrequency ablation guided by electro-anatomical mapping with high-density mapping catheter and radiofrequency ablation by contact force ablation catheter.\n2. Able to sign the consent form.\n\nExclusion Criteria:\n\n1. LVEF \\< 45%\n2. Presence of thrombus in the left atrium\n3. NYHA III/IV Class\n4. Atrial diameter \\> 50mm\n5. Moderate or severe valve dysfunction\n6. Implanted ICD/CRT-D\n7. Life expectancy \\< 1 year\n8. Uncontrolled Hyperthyroidism\n9. Hypertrophic or dilatative cardiomyopathy\n10. Kidney failure (eGFR \\< 30)\n11. Body Mass Index (BMI)\\> or = 35\n12. Participation in another clinical trial in the past 3 months\n13. Inability to express informed consent for the study\n14. Patients with esophageal pathologies and a history of gastritis\n15. Pregnancy (ascertained by performing the HCG test), breastfeeding, pregnancy planned during the study, or fertile female subjects who refused to use a highly effective contraceptive measure.'}, 'identificationModule': {'nctId': 'NCT05758805', 'acronym': 'ESO-SAFE-HP-RF', 'briefTitle': 'Esophageal Injury of a Tip CF Sensing Ablation Catheter for HP-SD of Paroxysmal and Persistent AF (ESO-SAFE-HP-RF)', 'organization': {'class': 'OTHER', 'fullName': 'Quovadis Associazione'}, 'officialTitle': 'Esophageal Injury of a Tip CF Sensing Ablation Catheter for HP-SD of Paroxysmal and Persistent AF', 'orgStudyIdInfo': {'id': 'ESO-SAFE-HP-RF Study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Unique Arm', 'description': 'patients with atrial fibrillation and indication for radiofrequency ablation guided by electro-anatomical mapping with high-density mapping catheter and radiofrequency ablation by contact force ablation catheter, according to current guidelines', 'interventionNames': ['Device: mini-invasive esophagoscopy', 'Device: HP-SD AF ablation by a CF sensing catheter']}], 'interventions': [{'name': 'mini-invasive esophagoscopy', 'type': 'DEVICE', 'description': 'mini-invasive esophagoscopy assessment of esophageal thermal injury (ETI) after an AF ablation session in an HP-SD setting, and with a tip CF sensing ablation catheter', 'armGroupLabels': ['Unique Arm']}, {'name': 'HP-SD AF ablation by a CF sensing catheter', 'type': 'DEVICE', 'description': 'AF ablation session in an HP-SD setting and with a tip CF sensing ablation catheter', 'armGroupLabels': ['Unique Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60126', 'city': 'Ancona', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Antonio Dello Russo, MD', 'role': 'CONTACT', 'email': 'antonio.dellorusso@ospedaliriuniti.marche.it', 'phone': '071 5965799'}], 'facility': 'SOD di Cardiologia e Aritmologia', 'geoPoint': {'lat': 43.60717, 'lon': 13.5103}}], 'centralContacts': [{'name': 'Antonio Dello Russo, MD', 'role': 'CONTACT', 'email': 'antonio.dellorusso@ospedaliriuniti.marche.it', 'phone': '+39 \u202d0715965798\u202c'}, {'name': 'Franco Noventa, MD', 'role': 'CONTACT', 'email': 'franco.noventa@quovadis-ass.it', 'phone': '+39 049715373'}], 'overallOfficials': [{'name': 'Antonio Dello Russo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiology and Arrhythmology Dept., Azienda Ospedaliero Universitaria delle Marche, Ancona (Italy)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'no IPD share planned'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Quovadis Associazione', 'class': 'OTHER'}, 'collaborators': [{'name': 'Abbott', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}