Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-01-20 @ 11:33 PM
Study NCT ID:
NCT03859167
Status:
TERMINATED
Last Update Posted:
2023-04-14
First Post:
2019-02-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Loss of AV Synchrony at Maximum Exercise
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005080', 'term': 'Exercise Test'}], 'ancestors': [{'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D016552', 'term': 'Ergometry'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'No Enrollments after COVID', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-09-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-04-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-11', 'studyFirstSubmitDate': '2019-02-27', 'studyFirstSubmitQcDate': '2019-02-27', 'lastUpdatePostDateStruct': {'date': '2023-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of participants with Loss of AV synchrony at maximum exercise', 'timeFrame': 'Baseline to end of stress test approximately 60 minutes.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Exercise', 'Pacemaker', 'Blood Pressure']}, 'descriptionModule': {'briefSummary': 'Investigators will identify a group of patients with complete heart block and a dual chamber pacemaker who will be expected to be able to exercise on a treadmill. Investigators will utilize symptom logs, cuff and continuous blood pressure monitoring. It is planned to study the symptomatic impact of loss of AV synchrony at significant levels of exercise.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients from cardiology clinic', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Complete AV Block\n* Age less than 60\n* Easily programmable dual chamber pacemaker\n\nExclusion Criteria:\n\n* Age \\> 60\n* Significant Heart Failure\n* Significant angina\n* History of claudication\n* Significant orthopedic issues\n* Evidence of sinus node dysfunction\n* Taking beta blockers or non-dihydropyridine calcium channel blockers'}, 'identificationModule': {'nctId': 'NCT03859167', 'acronym': 'SLAVSME', 'briefTitle': 'Study of the Loss of AV Synchrony at Maximum Exercise', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'SLAVSME - Study of the Loss of AV Synchrony at Maximum Exercise', 'orgStudyIdInfo': {'id': '190470'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants with AV block with pacemaker', 'description': 'Participants will have a stress test, and results will be collected and recorded.', 'interventionNames': ['Other: Stress Test']}], 'interventions': [{'name': 'Stress Test', 'type': 'OTHER', 'description': 'Participants will reach maximum exercise on a treadmill and results will be collected and recorded.', 'armGroupLabels': ['Participants with AV block with pacemaker']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Jay A. Montgomery, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medtronic', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Jay Montgomery', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}