Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2026-01-04 @ 8:33 AM
Study NCT ID:
NCT02211456
Status:
COMPLETED
Last Update Posted:
2021-03-04
First Post:
2014-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Assessment of Dual Site Left Ventricular Endocardial Pacing
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D017180', 'term': 'Tachycardia, Ventricular'}, {'id': 'D006333', 'term': 'Heart Failure'}], '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': 'D013610', 'term': 'Tachycardia'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'james.gamble@ouh.nhs.uk', 'phone': '00441865221012', 'title': 'Dr James Gamble', 'organization': 'Oxford University Hospitals NHS FT'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Participants', 'description': 'Having an ablation procedure with access to the left side of the heart\n\nAtrial Fibrillation/flutter (AF) or Ventricular Tachycardia (VT) ablation with multi-site pacing protocol: Pacing at several endocardial sites in isolation and individually will be performed, with response to this assessed by LV dp/dt max', 'otherNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Stroke', 'notes': 'One patient developed neurological symptoms shortly after waking up from anesthesia after his ventricular tachycardia ablation and was found to have had a left sided stroke.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Acute Haemodynamic Response to Dual Left Ventricular Pacing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants', 'description': 'Having an ablation procedure with access to the left side of the heart\n\nAtrial Fibrillation/flutter (AF) or Ventricular Tachycardia (VT) ablation with multi-site pacing protocol: Pacing at several endocardial sites in isolation and individually will be performed, with response to this assessed by LV dp/dt max'}], 'classes': [{'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '6.3'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.7', 'ciLowerLimit': '1', 'ciUpperLimit': '6.3', 'groupDescription': 'The data derived from this study was complex multi-level data with errors due to patient-level and intra-patient repeat factors. Accordingly, we used generalized multi-level modelling (GLMM) with random effects.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Mean of multiple recordings in each patient as detailed above', 'description': 'Acute haemodynamic response to pacing (change in Left Ventricular dP/dt max) between dual site Left Ventricular pacing and biventricular pacing Pacing protocols were performed with a baseline of 30 seconds of right ventricular pacing followed by two 30-second test configurations, and then a further baseline. The pacing configurations were tested, in a randomized order, 3 times each.\n\nElectrophysiology catheters were positioned at the right ventricular mid septum for baseline pacing, and at the left ventricular septum and at the left ventricular lateral wall, at the site of latest electrical activation i identified from a left ventricular electrical activation map This provided two single-site left ventricular pacing configurations, which could be combined to allow right ventricular and left ventricular lateral (Biventricular pacing) and left ventricular septal and left ventricular lateral (dual left ventricular pacing)', 'unitOfMeasure': '% difference', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Participants', 'description': 'Having an ablation procedure with access to the left side of the heart\n\nAtrial Fibrillation/flutter (AF) or Ventricular Tachycardia (VT) ablation with multi-site pacing protocol: Pacing at several endocardial sites in isolation and individually will be performed, with response to this assessed by LV dp/dt max\n\nAll patients underwent the pacing protocol'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Participants', 'description': 'Having an ablation procedure with access to the left side of the heart\n\nAtrial Fibrillation/flutter (AF) or Ventricular Tachycardia (VT) ablation with multi-site pacing protocol: Pacing at several endocardial sites in isolation and individually will be performed, with response to this assessed by LV dp/dt max'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68', 'spread': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Ischaemic aetiology of left ventricular dysfunction', 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Left ventricular ejection fraction', 'classes': [{'categories': [{'measurements': [{'value': '27', 'spread': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '%', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-11', 'studyFirstSubmitDate': '2014-08-01', 'resultsFirstSubmitDate': '2020-05-19', 'studyFirstSubmitQcDate': '2014-08-05', 'lastUpdatePostDateStruct': {'date': '2021-03-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-02-11', 'studyFirstPostDateStruct': {'date': '2014-08-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute Haemodynamic Response to Dual Left Ventricular Pacing', 'timeFrame': 'Mean of multiple recordings in each patient as detailed above', 'description': 'Acute haemodynamic response to pacing (change in Left Ventricular dP/dt max) between dual site Left Ventricular pacing and biventricular pacing Pacing protocols were performed with a baseline of 30 seconds of right ventricular pacing followed by two 30-second test configurations, and then a further baseline. The pacing configurations were tested, in a randomized order, 3 times each.\n\nElectrophysiology catheters were positioned at the right ventricular mid septum for baseline pacing, and at the left ventricular septum and at the left ventricular lateral wall, at the site of latest electrical activation i identified from a left ventricular electrical activation map This provided two single-site left ventricular pacing configurations, which could be combined to allow right ventricular and left ventricular lateral (Biventricular pacing) and left ventricular septal and left ventricular lateral (dual left ventricular pacing)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Endocardial pacing', 'Multi site pacing'], 'conditions': ['Atrial Fibrillation', 'Ventricular Tachycardia', 'Heart Failure']}, 'referencesModule': {'references': [{'pmid': '20797486', 'type': 'BACKGROUND', 'citation': 'Bordachar P, Derval N, Ploux S, Garrigue S, Ritter P, Haissaguerre M, Jais P. Left ventricular endocardial stimulation for severe heart failure. J Am Coll Cardiol. 2010 Aug 31;56(10):747-53. doi: 10.1016/j.jacc.2010.04.038.'}, {'pmid': '24525553', 'type': 'BACKGROUND', 'citation': 'Shetty AK, Sohal M, Chen Z, Ginks MR, Bostock J, Amraoui S, Ryu K, Rosenberg SP, Niederer SA, Gill J, Carr-White G, Razavi R, Rinaldi CA. A comparison of left ventricular endocardial, multisite, and multipolar epicardial cardiac resynchronization: an acute haemodynamic and electroanatomical study. Europace. 2014 Jun;16(6):873-9. doi: 10.1093/europace/eut420. Epub 2014 Feb 12.'}, {'pmid': '22312038', 'type': 'BACKGROUND', 'citation': 'Rogers DP, Lambiase PD, Lowe MD, Chow AW. A randomized double-blind crossover trial of triventricular versus biventricular pacing in heart failure. Eur J Heart Fail. 2012 May;14(5):495-505. doi: 10.1093/eurjhf/hfs004. Epub 2012 Feb 6.'}, {'pmid': '24425419', 'type': 'BACKGROUND', 'citation': 'Betts TR, Gamble JH, Khiani R, Bashir Y, Rajappan K. Development of a technique for left ventricular endocardial pacing via puncture of the interventricular septum. Circ Arrhythm Electrophysiol. 2014 Feb;7(1):17-22. doi: 10.1161/CIRCEP.113.001110. Epub 2014 Jan 14.'}]}, 'descriptionModule': {'briefSummary': 'We are investigating ways to help patients with heart failure, which is caused by damaged hearts which function less well, and cause symptoms of breathlessness, fatigue, lack of energy and swelling.\n\nCardiac Resynchronisation Therapy (CRT) pacemakers are used to improve the pumping function of the main heart chamber in certain suitable people with heart failure. CRT requires a pacemaker with 2 wires, one placed inside the right heart chamber and one normally placed on the outside of the left heart chamber. These two wires act together to re-time the coordination of the heartbeat, which is known to improve heart function.\n\nThe investigators are assessing whether they might be able to improve heart function even more by placing two wires on the inside of the left heart chamber, rather than one around the outside.\n\nThe investigators wish to assess whether:\n\n1. Using two wires within the left side of the heart gives a greater increase in heart function than one.\n2. It is possible to choose the best spot inside of the heart by measuring the pattern of the heart beat.\n3. Is it possible to use a different type of heart monitor placed outside the body instead of a monitor wire inside the heart to assess improvement in heart function? They are investigating this in people with hearts that beat less effectively than normal.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant is willing and able to give informed consent for participation in the study.\n* Male or Female, aged 60 years or above.\n* Having a suitable Atrial Fibrillation/flutter or Ventricular Tachycardia ablation procedure\n* Evidence of abnormal Left Ventricular structure and function, as shown by Left Ventricular ejection fraction of less than 40%\n\nExclusion Criteria:\n\n* Severe peripheral vascular disease (that would make arterial access more risky)\n* Haemodynamic instability (such that a longer procedure is inadvisable)'}, 'identificationModule': {'nctId': 'NCT02211456', 'acronym': 'DOUBLE-CRT', 'briefTitle': 'An Assessment of Dual Site Left Ventricular Endocardial Pacing', 'organization': {'class': 'OTHER', 'fullName': 'Oxford University Hospitals NHS Trust'}, 'officialTitle': 'Dual Site Left Endocardial Pacing for Cardiac Resynchronisation Therapy', 'orgStudyIdInfo': {'id': 'DOUBLE-CRT_72014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Participants', 'description': 'Having an ablation procedure with access to the left side of the heart', 'interventionNames': ['Procedure: Atrial Fibrillation/flutter (AF) or Ventricular Tachycardia (VT) ablation with multi-site pacing protocol']}], 'interventions': [{'name': 'Atrial Fibrillation/flutter (AF) or Ventricular Tachycardia (VT) ablation with multi-site pacing protocol', 'type': 'PROCEDURE', 'description': 'Pacing at several endocardial sites in isolation and individually will be performed, with response to this assessed by LV dp/dt max', 'armGroupLabels': ['Participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'OX3 7AT', 'city': 'Oxford', 'state': 'Oxfordshire', 'country': 'United Kingdom', 'facility': 'Oxford University Hospitals NHS Trust', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}], 'overallOfficials': [{'name': 'Tim R Betts, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oxford University Hospitals NHS Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oxford University Hospitals NHS Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Fellow', 'investigatorFullName': 'Dr James Gamble', 'investigatorAffiliation': 'Oxford University Hospitals NHS Trust'}}}}