Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2026-01-04 @ 2:24 PM
Study NCT ID:
NCT00180557
Status:
COMPLETED
Last Update Posted:
2015-03-17
First Post:
2005-09-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Austria Study - Analysis of Difference Between Active and Passive Fixation Leads
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001919', 'term': 'Bradycardia'}, {'id': 'D006327', 'term': 'Heart Block'}, {'id': 'D012804', 'term': 'Sick Sinus Syndrome'}], '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'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D001146', 'term': 'Arrhythmia, Sinus'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-10', 'studyFirstSubmitDate': '2005-09-15', 'studyFirstSubmitQcDate': '2005-09-15', 'lastUpdatePostDateStruct': {'date': '2015-03-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'QRS width'}, {'measure': 'Ejection fraction'}, {'measure': 'NYHA class'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Bradycardia', 'Heart Block', 'Sick Sinus Syndrome']}, 'descriptionModule': {'briefSummary': 'In this study the difference between screw in leads actively fixed in the septum and tined leads passively fixed in the apex concerning electrical parameters and implantation time will be evaluated. In addition the influence of the stimulation location by type of lead on QRS width, ejection fraction and NYHA class will be evaluated using and electrocardiogram and echocardiogram.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge \\< 18 years, indication for pacemaker implantation according to current guidelines, written consent of the patient\n\nExclusion Criteria:\n\nLive expectancy \\< 6 months, pregnancy or women without contraception in birth bearing age, inability or refusal to sign consent form, simultaneous participation in another clinical trial, contraindication for any procedure required during pacemaker implantation, patients who need other pacemaker systems including pacing leads than those required by the protocol, heart failure (LVEF \\<35%, QRS-Width\\>150ms), functional (rate dependent) bundle branch bloc'}, 'identificationModule': {'nctId': 'NCT00180557', 'briefTitle': 'Austria Study - Analysis of Difference Between Active and Passive Fixation Leads', 'organization': {'class': 'INDUSTRY', 'fullName': 'Guidant Corporation'}, 'officialTitle': 'Analyse Der Unterschiede Zwischen Aktiv-fixierenden Und Passiv-fixierenden Stimulations-Elektroden Hinsichtlich Implantationsdauer Und Elektrischer Parameter', 'orgStudyIdInfo': {'id': 'Austria Study v. 1.2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active fixation lead', 'description': 'Active fixation lead was implanted', 'interventionNames': ['Device: Flextend II, Fineline 2, Fineline Atrial J, Selute Picotip']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Passive fixation lead', 'description': 'Passive fixation lead was implanted', 'interventionNames': ['Device: Flextend II, Fineline 2, Fineline Atrial J, Selute Picotip']}], 'interventions': [{'name': 'Flextend II, Fineline 2, Fineline Atrial J, Selute Picotip', 'type': 'DEVICE', 'armGroupLabels': ['Active fixation lead', 'Passive fixation lead']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ried im Innkreis', 'country': 'Austria', 'facility': 'Krankenhaus der barmherzigen Schwestern', 'geoPoint': {'lat': 48.21123, 'lon': 13.48855}}], 'overallOfficials': [{'name': 'C Nimeth, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Krankenhaus der barmherzigen Schwestern Ried im Innkreis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guidant Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Rainer Habeler', 'oldOrganization': 'Guidant Austria'}}}}