Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-25 @ 7:10 PM
Study NCT ID:
NCT00875732
Status:
COMPLETED
Last Update Posted:
2017-07-11
First Post:
2009-03-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Choosing the Right Pacing Mode in Heart Failure - The CHOICE Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D001919', 'term': 'Bradycardia'}, {'id': 'D054537', 'term': 'Atrioventricular Block'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006327', 'term': 'Heart Block'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-07', 'studyFirstSubmitDate': '2009-03-31', 'studyFirstSubmitQcDate': '2009-03-31', 'lastUpdatePostDateStruct': {'date': '2017-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-04-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '6 minute hall walk test', 'timeFrame': 'Baseline, 3, 6, 9 and 12 months'}], 'secondaryOutcomes': [{'measure': 'Endothelial Function', 'timeFrame': 'Baseline, 3, 6, 9 and 12 months'}, {'measure': 'Cardiac Output', 'timeFrame': 'Baseline, 3, 6, 9 and 12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Resynchronization', 'Device', 'Bradycardia', 'atrioventricular block', 'Cardiac Resynchronization'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': "The aim of the study is to see if biventricular pacemakers offer any advantage over conventional pacemakers in patients with heart failure who require pacemakers. The endpoints will be the 6 minute walking distance along with markers of cardiovascular function.\n\nThe investigators' hypothesis is that biventricular pacing is preferable to conventional pacing in these heart failure patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Left ventricular systolic dysfunction.\n2. Atrio-ventricular node disease.\n3. Anticipated to be more than 40% paced, (including patients in permanent atrial fibrillation).\n4. Ability to walk independently (walking aid permitted).\n\nExclusion Criteria:\n\n1. Patients meeting criteria for CRT by current guidelines will be excluded.\n2. Life expectancy less than12 months.\n3. Inability to walk independently.\n4. Patients not likely to be compliant with follow-up.\n5. Bradyarrhythmia due with sino-atrial disease only.'}, 'identificationModule': {'nctId': 'NCT00875732', 'acronym': 'CHOICE', 'briefTitle': 'Choosing the Right Pacing Mode in Heart Failure - The CHOICE Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Dundee'}, 'officialTitle': 'CHOosing the rIght paCing Mode in Heart failurE : Should Heart Failure Patients With Bradycardia Receive Biventricular Pacemakers Rather Than Conventional Pacemakers?', 'orgStudyIdInfo': {'id': 'ELD001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Biventricular Pacing', 'interventionNames': ['Device: Bi Ventricular Pacing']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Right Ventricular Pacing', 'interventionNames': ['Device: Right Ventricular Pacing']}], 'interventions': [{'name': 'Bi Ventricular Pacing', 'type': 'DEVICE', 'armGroupLabels': ['1']}, {'name': 'Right Ventricular Pacing', 'type': 'DEVICE', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DD1 9SY', 'city': 'Dundee', 'state': 'UK', 'country': 'United Kingdom', 'facility': 'Ninewells Hospital & Medical School', 'geoPoint': {'lat': 56.46913, 'lon': -2.97489}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Dundee', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chest, Heart and Stroke Association Scotland', 'class': 'OTHER'}, {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Anna Maria Choy', 'investigatorFullName': 'AChoy', 'investigatorAffiliation': 'University of Dundee'}}}}