Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-26 @ 3:39 PM
Study NCT ID:
NCT01897558
Status:
COMPLETED
Last Update Posted:
2023-03-20
First Post:
2013-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Myocardial Micro-damage in Relation to Active and Passive Fixation Pacemaker Electrodes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001919', 'term': 'Bradycardia'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 290}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-17', 'studyFirstSubmitDate': '2013-05-02', 'studyFirstSubmitQcDate': '2013-07-11', 'lastUpdatePostDateStruct': {'date': '2023-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'high-sensitive Troponin T', 'timeFrame': '1 day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Bradyarrhythmia']}, 'referencesModule': {'references': [{'pmid': '29559697', 'type': 'RESULT', 'citation': 'Blazek P, Ferri-Certic J, Vrazic H, Lennerz C, Grebmer C, Kaitani K, Karch M, Starcevic B, Semmler V, Kolb C. Pacemaker Implantation Associated Myocardial Micro-Damage: A Randomised Comparison between Active and Passive Fixation Leads. Sci Rep. 2018 Mar 20;8(1):4870. doi: 10.1038/s41598-018-23209-5.'}]}, 'descriptionModule': {'briefSummary': 'Pacemaker electrodes are either equipped with tines (passive fixation) or with a screw (active fixation) for initial fixation in the patient´s heart. Both types of electrodes provide similar results in a long-term follow-up and the use of one or the other electrode type in many instances is mainly based on the implanter´s preference. The PACMAN-trial investigates whether the two lead types are associated with different amounts of myocardial micro-damage during implantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* de-novo implantation of a pacemaker system\n\nExclusion Criteria:\n\n* AAI pacing or cardiac resynchronization therapy\n* ICD indication\n* temporary pacing\n* lead revision\n* right ventricular pacing aimed from alternative pacing sites (other than the apex)\n* lead revision\n* severe tricuspid valve regurgitation\n* previous myocardial infarction, coronary intervention, stroke, cardioversion or ablation in the presence of elevated troponin levels\n* dialysis'}, 'identificationModule': {'nctId': 'NCT01897558', 'acronym': 'PACMAN', 'briefTitle': 'Myocardial Micro-damage in Relation to Active and Passive Fixation Pacemaker Electrodes', 'organization': {'class': 'OTHER', 'fullName': 'Deutsches Herzzentrum Muenchen'}, 'officialTitle': 'Effect of Passive Versus Active Fixation Leads on the Magnitude of Troponin Release After Pacemaker Implantation (PACMAN Trial)', 'orgStudyIdInfo': {'id': 'GER-EP-012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ventricular pacemaker electrode', 'description': 'receives an active fixation ventricular pacemaker electrode', 'interventionNames': ['Device: Pacemaker implantation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Passive fixation ventricular pacemaker electrode', 'description': 'receives a passive fixation ventricular pacemaker electrode', 'interventionNames': ['Device: Pacemaker implantation']}], 'interventions': [{'name': 'Pacemaker implantation', 'type': 'DEVICE', 'armGroupLabels': ['Passive fixation ventricular pacemaker electrode', 'Ventricular pacemaker electrode']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10000', 'city': 'Zagreb', 'country': 'Croatia', 'facility': 'University Hospital Dubrava', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'city': 'Kempten', 'country': 'Germany', 'facility': 'Klinikum Kempten', 'geoPoint': {'lat': 49.96729, 'lon': 7.93702}}, {'city': 'Landhut', 'country': 'Germany', 'facility': 'Krankenhaus Landshut-Achdorf'}, {'zip': '80636', 'city': 'München', 'country': 'Germany', 'facility': 'Deutsches Herzzentrum München', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'city': 'Mishima', 'country': 'Japan', 'facility': 'Kenri Hospital', 'geoPoint': {'lat': 35.11667, 'lon': 138.91667}}], 'overallOfficials': [{'name': 'Christof Kolb, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Deutsches Herzzentrum München'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Deutsches Herzzentrum Muenchen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}