Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2026-02-20 @ 6:46 PM
Study NCT ID:
NCT01053832
Status:
COMPLETED
Last Update Posted:
2011-10-25
First Post:
2010-01-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ventricular Pace Suppression Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-24', 'studyFirstSubmitDate': '2010-01-19', 'studyFirstSubmitQcDate': '2010-01-20', 'lastUpdatePostDateStruct': {'date': '2011-10-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of right ventricular pacing with the help of the VpS algorithm in the EVIA/ ENTOVIS pacemakers.', 'timeFrame': '6-8 months'}], 'secondaryOutcomes': [{'measure': 'A Complication free rate >95%, with respect to the VpS feature of the implanted pacemaker.', 'timeFrame': '6-8 months'}]}, 'conditionsModule': {'keywords': ['ventricular pace suppression', 'pacemaker', 'efficacy', 'safety', 'support of intrinsic heart rhythm'], 'conditions': ['Pacemaker Indication']}, 'descriptionModule': {'briefSummary': 'Investigation of the efficacy and safety of the Ventricular Pace Suppression (VpS) algorithm.', 'detailedDescription': 'The aim of this study is to investigate the percentage of reduction of ventricular pacing using the VpS feature of the EVIA/ENTOVIS pacemaker in a controlled clinical investigation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Paroxysmal AV block and/or Sinus Node Dysfunction\n* DDD(R)-ADI(R)-Mode (VpS Algorithm) applicability\n\nExclusion Criteria:\n\n* Permanent AV block III°\n* Permanent Atrial Fibrillation/ Flutter\n* Require mode other than DDD(R)-ADI(R) or DDD(R)\n* Have a life expectancy of less than six months\n* Expected to receive heart surgery within six months\n* Enrolled in another cardiac investigation'}, 'identificationModule': {'nctId': 'NCT01053832', 'acronym': 'VpS', 'briefTitle': 'Ventricular Pace Suppression Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biotronik SE & Co. KG'}, 'officialTitle': 'Ventricular Pace Suppression Study With the EVIA/ENTOVIS DR-T/DR Pacemaker', 'orgStudyIdInfo': {'id': '45'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Ventricular Pace Suppression- ON', 'interventionNames': ['Device: VpS algorithm in EVIA and ENTOVIS pacemakers']}, {'type': 'OTHER', 'label': 'Ventricular Pace Suppression- OFF', 'interventionNames': ['Device: VpS algorithm in EVIA and ENTOVIS pacemakers']}], 'interventions': [{'name': 'VpS algorithm in EVIA and ENTOVIS pacemakers', 'type': 'DEVICE', 'description': 'For one group of patients, the VpS algorithm will be activated and for the other group, the VpS algorithm will be deactivated until the cross-over, where these conditions will be switched.', 'armGroupLabels': ['Ventricular Pace Suppression- OFF', 'Ventricular Pace Suppression- ON']}]}, 'contactsLocationsModule': {'locations': [{'zip': '96450', 'city': 'Coburg', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Klinikum Coburg gGmbH', 'geoPoint': {'lat': 50.25937, 'lon': 10.96384}}, {'zip': '24105', 'city': 'Kiel', 'state': 'Schleswig-Holstein', 'country': 'Germany', 'facility': 'Abteilung für Elektrophysiologie, Klinik für Kardiologie und Angiologie, UNIVERSITÄTSKLINIKUM Schleswig-Holstein', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}], 'overallOfficials': [{'name': 'Hendrik Bonnemeier, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinik für Kardiologie und Angiologie, UNIVERSITÄTSKLINIKUM Schleswig-Holstein, Campus Kiel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biotronik SE & Co. KG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}