Ignite Creation Date:
2025-12-24 @ 12:20 PM
Ignite Modification Date:
2025-12-24 @ 12:20 PM
Study NCT ID:
NCT05086861
Status:
COMPLETED
Last Update Posted:
2021-10-21
First Post:
2019-08-29
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Oesophageal Pacing to Check Left Atrial Posterior Wall Isolation
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-07', 'studyFirstSubmitDate': '2019-08-29', 'studyFirstSubmitQcDate': '2021-10-07', 'lastUpdatePostDateStruct': {'date': '2021-10-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Left atrial posterior wall isolation', 'timeFrame': 'Through study completion, an average of 4 years', 'description': 'Measured via invasive left atrial mapping'}], 'secondaryOutcomes': [{'measure': 'Complication rate', 'timeFrame': 'Through study completion, an average of 4 years', 'description': 'Documentation of the number of complications caused by the oesophageal pacing procedure'}, {'measure': 'Feasibility of using device', 'timeFrame': 'Through study completion, an average of 4 years', 'description': 'The success rate of left atrial posterior wall isolation.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Oesophageal Pacing', 'Hybrid Ablation', 'Persistent Atrial Fibrillation'], 'conditions': ['Persistent Atrial Fibrillation', 'Atrial Fibrillation Ablation']}, 'descriptionModule': {'briefSummary': 'Patients undergoing hybrid AF ablation second stage catheter ablation have the posterior left atrium mapped to see it if is electrically isolated. This is done via a standard electrophysiogical study in accordance with routine clinical practice.\n\nInvestigators propose to check left atrium posterior wall isolation via oesophageal pacing and compare this to findings from invasive study', 'detailedDescription': 'Oesophageal temporary pacing of the heart is an established treatment in heart block and several catheters are licenced for this purpose with minimal procedural risks. Due to the position of the oesophagus, pacing from the oesophagus could sense and pace the posterior left atrium. If the posterior wall could be demonstrated to be electrically isolated with oesophageal pacing then invasive electrophysiological study such as the second stage of a hybrid AF ablation would be unnecessary.\n\nThis would save patients from undergoing invasive left atrial mapping and exposure to the consequent risks of the procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria: • subjects capable of giving informed consent,\n\n* Male or female\n* Aged between 18 and 80 years\n* Undergoing ablation under general anaesthetic with planned isolation of the left atrial posterior wall or who have previously undergone either catheter or surgical ablation for AF with LA posterior wall isolation\n\nExclusion Criteria:\n\n* Unable or willing to give fully informed written consent\n* Turned down for general anaesthetic\n* Pregnancy\n* Terminal illness\n* Any other significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate."}, 'identificationModule': {'nctId': 'NCT05086861', 'briefTitle': 'Oesophageal Pacing to Check Left Atrial Posterior Wall Isolation', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Plymouth NHS Trust'}, 'officialTitle': 'Oesophageal Pacing to Check Left Atrial Posterior Wall Isolation: A Pilot Study', 'orgStudyIdInfo': {'id': '15/P/094'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oesophageal Pacing Arm', 'description': 'Patients undergoing atrial fibrillation ablation to isolate the left atrial posterior wall via catheter or staged hybrid ablation.', 'interventionNames': ['Device: Oesophageal pacing after left atrial posterior wall isolation']}], 'interventions': [{'name': 'Oesophageal pacing after left atrial posterior wall isolation', 'type': 'DEVICE', 'description': 'Following AF ablation with the aim of isolating the left atrial posterior wall oesophageal pacing and sensing is performed to check for left atrial posterior wall. entrance and exit block.', 'armGroupLabels': ['Oesophageal Pacing Arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Plymouth', 'country': 'United Kingdom', 'facility': 'Derriford Hospital', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}], 'overallOfficials': [{'name': 'Guy Haywood, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Plymouth NHS Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Plymouth NHS Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}