Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-02-26 @ 12:41 AM
Study NCT ID:
NCT02485093
Status:
COMPLETED
Last Update Posted:
2019-02-04
First Post:
2013-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Pace or Not to Pace in Sinus Node Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012804', 'term': 'Sick Sinus Syndrome'}], 'ancestors': [{'id': 'D001146', 'term': 'Arrhythmia, Sinus'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006327', 'term': 'Heart Block'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 215}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-01', 'studyFirstSubmitDate': '2013-07-26', 'studyFirstSubmitQcDate': '2015-06-29', 'lastUpdatePostDateStruct': {'date': '2019-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Left Ventricular Endsystolic Diameter (LVED)', 'timeFrame': '18 months'}], 'secondaryOutcomes': [{'measure': 'AF incidence', 'timeFrame': '18 months'}, {'measure': 'Hospitalizations', 'timeFrame': '18 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Sinus Node Disease']}, 'descriptionModule': {'briefSummary': 'Optimal pacing strategy for patients with SND is still unknown, although several publications in the past years demonstrated a deleterious effect of ventricular pacing. However, pacing has always been apical in these trials, and to which extent this absence of pacing is beneficial for patients with very long PR intervals is still to be found.\n\nThe aim of this study is to compare ventricular septal pacing to no pacing in patients with SND.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with sinus node disease\n\nExclusion Criteria:\n\n* Complete or high degree AV block\n* Permanent atrial fibrillation'}, 'identificationModule': {'nctId': 'NCT02485093', 'acronym': 'OPTIMIST', 'briefTitle': 'To Pace or Not to Pace in Sinus Node Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'Comparison of Ventricular Septal Pacing With Optimized Atrioventricular (AV) Delay to no Pacing in Sinus Node Disease (SND) Patients.', 'orgStudyIdInfo': {'id': '2008-A01266-49'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'No pacing', 'description': 'Ventricular intrinsic conduction enhanced', 'interventionNames': ['Device: VIP']}, {'type': 'EXPERIMENTAL', 'label': 'Pacing', 'description': 'Septal ventricular pacing with optimized AV delay', 'interventionNames': ['Device: Septal ventricular pacing']}], 'interventions': [{'name': 'Septal ventricular pacing', 'type': 'DEVICE', 'description': 'Ventricular pacing must be at least 90%, from the septum and with optimized AV delay', 'armGroupLabels': ['Pacing']}, {'name': 'VIP', 'type': 'DEVICE', 'description': 'Ventricular pacing must be less than 10%.', 'armGroupLabels': ['No pacing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35000', 'city': 'Rennes', 'country': 'France', 'facility': 'CHU Pontchaillou - CCP', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}