Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2025-12-25 @ 8:25 PM
Study NCT ID:
NCT00275769
Status:
COMPLETED
Last Update Posted:
2008-12-11
First Post:
2006-01-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CAPTURE - Complete Automatic Pacing Threshold Utilization Recorded by EnPulse
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D001919', 'term': 'Bradycardia'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'count': 860}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-12', 'completionDateStruct': {'date': '2006-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-12-10', 'studyFirstSubmitDate': '2006-01-11', 'studyFirstSubmitQcDate': '2006-01-11', 'lastUpdatePostDateStruct': {'date': '2008-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The automatic device features Atrial Capture Management and Ventricular Capture Management measure pacing thresholds and is compared to manual pacing thresholds observed at the 6 month follow-up visit'}], 'secondaryOutcomes': [{'measure': 'Observe the variability of multiple pacing thresholds measured with ACM and VCM'}, {'measure': 'Observe visit time differences using automatic measurements versus traditional follow-up'}, {'measure': 'Observe the effects of Post Mode Switch Overdrive Pacing (PMOP) on AT/AF burden.'}]}, 'conditionsModule': {'keywords': ['Arrhythmia', 'Bradycardia', 'Cardiac Pacemaker Artificial'], 'conditions': ['Arrhythmia', 'Bradycardia']}, 'referencesModule': {'references': [{'pmid': '20545869', 'type': 'DERIVED', 'citation': 'Rosenthal LS, Mester S, Rakovec P, Penaranda JB, Sherman JR, Sheldon TJ, Zeng C, Wang P; CAPTURE Trial Investigators. Factors influencing pacemaker generator longevity: results from the complete automatic pacing threshold utilization recorded in the CAPTURE Trial. Pacing Clin Electrophysiol. 2010 Aug;33(8):1020-30. doi: 10.1111/j.1540-8159.2010.02809.x. Epub 2010 Jun 2.'}]}, 'descriptionModule': {'briefSummary': "This study compares the pacemaker's automatic pacing threshold measurements to the manual measurements conducted by a health care provider.", 'detailedDescription': 'The purpose(s) of the study is (are) to evaluate several features available in EnPulse Series pacemaker and report the long term benefit of Atrial Capture Management (ACM) and Ventricular Capture Management (VCM) as demonstrated by accuracy in comparison with manual measurements and variability of ACM and VCM thresholds.\n\nIn addition, an evaluation of the timesaving and qualitative benefits of the device feature known as Quick Look II (the computer interface screen of the device programmer) will be measured through the use of a questionnaire completed by the health care professionals involved in patient follow-up care.\n\nThis is a one-to-one randomized, multicenter, prospective study in which patients receiving new EnPulse pacemaker implants will be randomized to each of three study arms, 1) routine manual follow-up and follow-up using the automatic features; 2) ACM diagnostics detail on or VCM diagnostics detail on; 3) PMOP on / off or PMOP off / on (6 month cycle).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Patients that meet ACC/AHA/NASPE 2002 class I or II dual chamber pacing indications (intended for a Pacing Mode programmed to DDD or DDDR)\n\nExclusion Criteria:\n\n* Patient with mechanical tricuspid heart valves\n* Patients with medical conditions that preclude the testing required by the protocol or limit study participation'}, 'identificationModule': {'nctId': 'NCT00275769', 'briefTitle': 'CAPTURE - Complete Automatic Pacing Threshold Utilization Recorded by EnPulse', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Cardiac Rhythm and Heart Failure'}, 'officialTitle': 'Complete Automatic Pacing Threshold 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