Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2026-01-01 @ 7:13 PM
Study NCT ID:
NCT00366158
Status:
COMPLETED
Last Update Posted:
2019-02-04
First Post:
2006-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EVITA: Evaluation of VIP Feature in Pacemaker Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}], '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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 461}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-01', 'studyFirstSubmitDate': '2006-08-18', 'studyFirstSubmitQcDate': '2006-08-18', 'lastUpdatePostDateStruct': {'date': '2019-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-08-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of ventricular pacing', 'timeFrame': '6 and 12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Patients with intact AV conduction'], 'conditions': ['Arrhythmia']}, 'referencesModule': {'references': [{'pmid': '26315154', 'type': 'DERIVED', 'citation': 'Bauer A, Vermeulen J, Toivonen L, Voitk J, Barr C, Peytchev P. Minimizing right ventricular pacing in pacemaker patients with intact and compromised atrioventricular conduction : Results from the EVITA Trial. Herzschrittmacherther Elektrophysiol. 2015 Dec;26(4):359-66. doi: 10.1007/s00399-015-0394-2. Epub 2015 Aug 28.'}]}, 'descriptionModule': {'briefSummary': 'The primary efficacy objective of this clinical investigation is to demonstrate that the Ventricular Intrinsic Preference (VIP™) feature allows to reduce the medium- and long-term incidence of unnecessary ventricular pacing in patients with intact AV conduction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has an indication for implantation of a dual-chamber pacemaker;\n* Patient is implanted or scheduled to be implanted with a St Jude Medical Victory pacemaker, or newer device with the same study relevant feature.\n\nExclusion Criteria:\n\n* Patient has persistent or permanent AF/AFl;\n* Patient has permanent AV Block;\n* Patient has a pacemaker replacement;\n* Patient is in NYHA class IV;\n* Patient is unable to attend the follow-up visits;\n* Patient is pregnant;\n* Patient is less than 18 years of age'}, 'identificationModule': {'nctId': 'NCT00366158', 'briefTitle': 'EVITA: Evaluation of VIP Feature in Pacemaker Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'EVITA: Evaluation of VIP Feature in Pacemaker Patients', 'orgStudyIdInfo': {'id': 'CR06001LV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Ventricular Instrinsic Preference (VIP) turned ON', 'interventionNames': ['Device: Device: St. Jude Medical Victory dual-chamber pacemaker', 'Device: Ventricular Intrinsic Preference']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Ventricular Instrinsic Preference (VIP) turned OFF', 'interventionNames': ['Device: Device: St. Jude Medical Victory dual-chamber pacemaker', 'Device: Ventricular Intrinsic Preference']}], 'interventions': [{'name': 'Device: St. Jude Medical Victory dual-chamber pacemaker', 'type': 'DEVICE', 'description': 'Pacemaker implant', 'armGroupLabels': ['1', '2']}, {'name': 'Ventricular Intrinsic Preference', 'type': 'DEVICE', 'description': 'Programming of pacemaker', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69115', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Universitätskliniken Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '413 45', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Sahlgrenska University Hospital', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}], 'overallOfficials': [{'name': 'Alexander Bauer, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Universitätskliniken Heidelberg, Heidelberg, 69115, Germany'}, {'name': 'Charles Kennergren, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sahlgrenska University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Christophe Bailleul', 'oldOrganization': 'St. Jude Medical'}}}}