Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2025-12-26 @ 3:53 AM
Study NCT ID:
NCT06018818
Status:
COMPLETED
Last Update Posted:
2025-08-24
First Post:
2023-07-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Post Market Clinical Follow-up Study for the Amvia/Solvia Pacemaker Family
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001919', 'term': 'Bradycardia'}, {'id': 'D006333', 'term': 'Heart Failure'}], '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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 129}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-07-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-22', 'studyFirstSubmitDate': '2023-07-17', 'studyFirstSubmitQcDate': '2023-08-29', 'lastUpdatePostDateStruct': {'date': '2025-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SADE-free rate at 6 months', 'timeFrame': '6 months', 'description': 'Kaplan-Meier estimate of Amvia-related SADE-free rate at 6 months'}], 'secondaryOutcomes': [{'measure': 'SADE-free rate at 12 months', 'timeFrame': '12 months', 'description': 'Kaplan-Meier estimate of Amvia-related SADE-free rate at 12 months'}, {'measure': 'CRT AutoAdapt performance', 'timeFrame': '12 months', 'description': 'CRT AutoAdapt: different pacing percentages'}, {'measure': 'CRT AutoAdapt AV delay', 'timeFrame': '12 months', 'description': 'Mean adapted AV delay after pace/sense'}, {'measure': 'Assessment of the CRT AutoAdapt feature (CRT-devices only) by the investigator', 'timeFrame': '12 months', 'description': 'Investigator appraisal of the overall handling of the feature (score: very good/good/ adequate/poor/very poor)'}, {'measure': 'Auto LV VectorOpt', 'timeFrame': '12 months', 'description': 'Time needed for threshold measurement'}, {'measure': 'Assessment of the Automatic LV VectorOpt test (CRT-devices only) by the investigator', 'timeFrame': '2 months', 'description': 'Investigator appraisal of the overall handling of the feature (score: very good/good/ adequate/poor/very poor)'}, {'measure': 'aATP-related ADEs and SADEs', 'timeFrame': '12 months', 'description': 'aATP-related ADEs and SADEs'}, {'measure': 'Sensing performance of device-based measurements', 'timeFrame': '12 months', 'description': 'The appropriateness of sensing performance will be assessed by calculating the percentage of appropriate sensing for all leads.'}, {'measure': 'Pacing performance of device-based measurements', 'timeFrame': '12 months', 'description': 'The appropriateness of pacing performance will be assessed by calculating the percentage of appropriate pacing for all leads.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bradycardia', 'Heart Failure']}, 'descriptionModule': {'briefSummary': 'The study is designed as an open-label, prospective, international, multicenter, non-randomized study to determine safety and product performance of the CE-marked Amvia/Solvia pacemaker family, including the aATP, CRT AutoAdapt and Early Check features in the setting of a post-market clinical follow-up study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Standard indication for de novo, upgrade or replacement pacemaker or cardiac resynchronization therapy pacemaker (CRT-P) implantation\n* Ability to understand the nature of the study\n* Willingness to provide written informed consent\n* Ability and willingness to perform all follow-up visits at the study site\n* Ability and willingness to use the CardioMessenger and acceptance of the BIOTRONIK Home Monitoring® concept\n\nExclusion Criteria:\n\n* Planned for conduction system pacing\n* Planned cardiac surgical procedures or interventional measures other than the study procedure within the next 12 months\n* Known pregnancy or breast feeding\n* Age less than 18 years\n* Participation in another interventional clinical investigation\n* Life-expectancy less than 12 months'}, 'identificationModule': {'nctId': 'NCT06018818', 'briefTitle': 'Post Market Clinical Follow-up Study for the Amvia/Solvia Pacemaker Family', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biotronik SE & Co. KG'}, 'officialTitle': 'BIO|MASTER.Amvia: Post Market Clinical Follow-up Study for the Amvia/Solvia Pacemaker Family', 'orgStudyIdInfo': {'id': 'BA114'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Amvia pacemaker or CRT-P implantation', 'interventionNames': ['Device: Amvia/Solvia pacemaker family']}], 'interventions': [{'name': 'Amvia/Solvia pacemaker family', 'type': 'DEVICE', 'description': 'Implantation of a pacemaker or CRT-P devices', 'armGroupLabels': ['Amvia pacemaker or CRT-P implantation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Linz', 'country': 'Austria', 'facility': 'Kepler Universitätsklinikum', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'city': 'Essen', 'country': 'Germany', 'facility': 'Elisabeth-Krankenhaus Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'city': 'Mönchengladbach', 'country': 'Germany', 'facility': 'Kliniken Maria Hilf GmbH', 'geoPoint': {'lat': 51.18539, 'lon': 6.44172}}], 'overallOfficials': [{'name': 'Istvan Szendey, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kliniken Maria Hilf GmbH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biotronik SE & Co. KG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}