Ignite Creation Date:
2025-12-24 @ 5:01 PM
Ignite Modification Date:
2025-12-28 @ 1:26 PM
Study NCT ID:
NCT00941850
Status:
COMPLETED
Last Update Posted:
2015-12-08
First Post:
2009-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Triple-site Ventricular Pacing in Patients Who Have Not Responded to Conventional Dual Ventricular Site Cardiac Resynchronization Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-07', 'studyFirstSubmitDate': '2009-07-16', 'studyFirstSubmitQcDate': '2009-07-17', 'lastUpdatePostDateStruct': {'date': '2015-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of responders in each group. o Clinical response will be defined according to the Packer score o Echocardiographic response will be defined as a 10% relative reduction in left ventricular end systolic volume at six months', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'NYHA class', 'timeFrame': '3 and 6 months'}, {'measure': 'ECHO parameters (LVEDV/ESV, LVEF, MR severity, dyssynchrony indices: time to peak velocity/strain/deformation/time to minimal volume)', 'timeFrame': '3 and 6 months'}, {'measure': 'MVO2 max', 'timeFrame': '6 months'}]}, 'conditionsModule': {'keywords': ['Cardiac resynchronizton therapy', 'CRT', 'Heart failure', 'Dyssynchrony', 'Echocardiography', 'Pacemakers', 'Nonresponders'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'Patients are randomised to receive ongoing optimised device and medical therapy or triple ventricular site resynchronisation. The hypothesis states that patients receiving triple-site resynchronization will exhibit a better response.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Implanted with a CRT device \\> 6 months previously according to current and conventional CRT indications\n* Device optimization \\> 1 months previously\n* Aged 18yrs or older\n* Able to attend outpatient follow up\n\nExclusion Criteria:\n\n* Recent MI (\\<2 months)\n* Women who are pregnant or planning pregnancy\n* Severe co morbid illness (where patients are not expected to survive duration of follow up period or where repeated outpatient visits may not be in best interest of patients)\n* Upgrade procedure is contraindicated for safety reasons.\n* Class IV inotropic agents\n* Patient unwilling to comply with required follow-up protocol including randomization scheme'}, 'identificationModule': {'nctId': 'NCT00941850', 'acronym': 'TRIVENT', 'briefTitle': 'A Study of Triple-site Ventricular Pacing in Patients Who Have Not Responded to Conventional Dual Ventricular Site Cardiac Resynchronization Therapy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospitals, Leicester'}, 'officialTitle': 'TRIple-site VENTricular Pacing in Non-responders to Conventional Dual Ventricular Site Cardiac Resynchronization Therapy', 'orgStudyIdInfo': {'id': 'UHL10707'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Triple site CRT', 'description': 'These patients will continue to receive CRT via existing device but will have a change in the mode of delivery of therapy (by placing a second pacing lead to reach a different part of the left ventricle from the part originally paced', 'interventionNames': ['Procedure: Upgrade to triple ventricular site CRT']}, {'type': 'NO_INTERVENTION', 'label': 'Optimised medical and device therapy', 'description': 'These patients will receive optimised medical and device therapy.'}], 'interventions': [{'name': 'Upgrade to triple ventricular site CRT', 'type': 'PROCEDURE', 'description': 'Patients in this arm will continue to receive CRT via the original unit, but some will have a change in the mode of delivery of therapy (by placing a second pacing lead to reach a different part of the left ventricle from the part originally paced).', 'armGroupLabels': ['Triple site CRT']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'LE3 9QP', 'city': 'Leicester', 'state': 'England', 'country': 'United Kingdom', 'facility': 'University of Leicester HNS trust', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}], 'overallOfficials': [{'name': 'GAndre Ng, MB ChB, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Leicester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospitals, Leicester', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}