Ignite Creation Date:
2025-12-24 @ 3:27 PM
Ignite Modification Date:
2025-12-27 @ 9:23 PM
Study NCT ID:
NCT04734392
Status:
COMPLETED
Last Update Posted:
2023-11-29
First Post:
2021-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reducing Pacemaker Implantation After TAVR With Modified Implantation Technique
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-28', 'studyFirstSubmitDate': '2021-01-26', 'studyFirstSubmitQcDate': '2021-01-27', 'lastUpdatePostDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pacemaker implantation rate', 'timeFrame': 'Day 5 after TAVR', 'description': 'Primary endpoint'}], 'secondaryOutcomes': [{'measure': 'Extent of paravalvular leak', 'timeFrame': 'Day 5 after TAVR', 'description': 'Secondary endpoint'}, {'measure': 'Number of patients alive', 'timeFrame': '30 days', 'description': 'Secondary endpoint'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['PM Implantation After TAVR']}, 'descriptionModule': {'briefSummary': 'Hypothesis of the study is that a modified and improved implantation protocol (regarding membranous septum length and implantation depth) will decrease the need for permanent pacemaker stimulation follow TAVR-procedures.', 'detailedDescription': 'Project objectives or hypothesis Hypothesis of the study is that a modified and improved implantation protocol (regarding membranous septum length and implantation depth) will decrease the need for permanent pacemaker stimulation following TAVR-procedures.\n\nPatient profile and sample size The study cohort will comprise of patients referred to transcatheter aortic valve replacement. Patients will be prospectively and consecutively screened and enrolled at a tertiary high-volume center in Germany. TAVR will be performed according to a modified implantation technique regarding membranous septum length. Pacemaker rates will be analyzed and compared to a historical control. Taking into account a contemporary pacemaker rate of 15%, a reduction to 7% will require a sample size of 239 patients per group to achieve statistically significance (Chi-squared test, alpha 0.05, beta 0.80).\n\nRegarding the prospective cohort, interims analysis will be performed after each 10 TAVR procedures. In case a signal towards worse outcomes with the modified implantation technique will be observed, the institutional safety and endpoint adjudication committee will stop further execution of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study cohort will comprise of patients referred to transcatheter aortic valve replacement. Patients will be prospectively and consecutively screened and enrolled at a tertiary high-volume center in Germany.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients referred to TAVR procedure due to severe aortic stenosis\n\nExclusion Criteria:\n\n* PM-implantation before TAVR\n* Valve-in-valve procedures'}, 'identificationModule': {'nctId': 'NCT04734392', 'acronym': 'MIDAS - ULM', 'briefTitle': 'Reducing Pacemaker Implantation After TAVR With Modified Implantation Technique', 'organization': {'class': 'OTHER', 'fullName': 'University of Ulm'}, 'officialTitle': 'Reducing Pacemaker Implantation After TAVR With Modified Implantation Technique', 'orgStudyIdInfo': {'id': '01/2021'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort A', 'description': 'Historical cohort 2019 + 2020'}, {'label': 'Cohort B', 'description': 'Prospective study cohort 2020 + 2021 (TAVR implantation according new IFU)', 'interventionNames': ['Procedure: TAVR']}], 'interventions': [{'name': 'TAVR', 'type': 'PROCEDURE', 'description': 'TAVR implantation in cusp overlay technique', 'armGroupLabels': ['Cohort B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89081', 'city': 'Ulm', 'country': 'Germany', 'facility': 'Ulm University', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Ulm', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PD Dr. Dominik Buckert, MD', 'investigatorFullName': 'Dr. Dominik Buckert', 'investigatorAffiliation': 'University of Ulm'}}}}