Ignite Creation Date:
2025-12-24 @ 4:13 PM
Ignite Modification Date:
2026-02-24 @ 2:31 PM
Study NCT ID:
NCT06508866
Status:
RECRUITING
Last Update Posted:
2024-07-22
First Post:
2024-07-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Timing And Typology of ConducTIon disturbanCes During TAVI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 490}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-19', 'studyFirstSubmitDate': '2024-07-15', 'studyFirstSubmitQcDate': '2024-07-15', 'lastUpdatePostDateStruct': {'date': '2024-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prediction of new requirement for permanent pacemaker after TAVI', 'timeFrame': '0-24 months', 'description': 'The primary focus of the registry is evaluating which patient characteristics and conduction disturbances may help to predict the new requirement for permanent pacemaker after TAVI.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['TAVI', 'Pacemaker', 'aortic stenosis'], 'conditions': ['Aortic Stenosis, Severe']}, 'descriptionModule': {'briefSummary': 'The TACTIC-TAVI registry aims to collect information about a consecutive cohort of patients undergoing transcatheter aortic valve insertion. The registry is international, multi-centre and observational. The registry is planned to continue until the calculated sample size is achieved.', 'detailedDescription': 'All patients since February 2023 treated successfully with TAVI until the study endpoint will be deemed suitable for inclusion in the registry. The registry will:\n\n1. collect the baseline clinical features of the study population.\n2. evaluate the electrocardiogram (ECG) and contrast tomography (CT) scan parameters.\n3. collect procedural characteristics including type and timing of any conduction disturbance\n4. collect follow-up data including post-procedural ECG, echocardiographic and clinical outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study is a retrospective and prospective registry aiming to observe intra-procedural conduction disturbances in patients undergoing TAVI for severe aortic stenosis. Patients will have no alteration to standard post-procedural management and will their have usual follow-up. There are four key time points: 1) pre-procedure 2) intra-procedure 3) post-procedure 4) discharge. The electrocardiogram will be assessed at timepoints 1-3 and requirement for permanent pacemaker insertion by timepoint 4.', 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients successfully undergoing transcatheter aortic valve implantation for native severe aortic stenosis.\n\n\\-\n\nExclusion Criteria:\n\n1. Presence of previously implanted permanent cardiac pacemaker.\n2. Valve-in-valve procedures.\n3. No pre-procedural electrocardiogram is available.\n4. No pre-procedural contrast CT TAVI is available.\n5. Enrollment in another clinical trial.\n6. Patients aged less than 18 years old.\n7. Patients who do not consent for their data to be included in the registry.\n8. Failed transcatheter aortic valve deployment. -'}, 'identificationModule': {'nctId': 'NCT06508866', 'acronym': 'TACTIC-TAVI', 'briefTitle': 'Timing And Typology of ConducTIon disturbanCes During TAVI', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Clinico Humanitas'}, 'officialTitle': 'Timing And Typology of ConducTIon disturbanCes During TAVI: the TACTIC-TAVI Registry', 'orgStudyIdInfo': {'id': '3328'}}, 'contactsLocationsModule': {'locations': [{'zip': '20089', 'city': 'Rozzano', 'state': 'Milano', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Antonio Mangieri, MD', 'role': 'CONTACT', 'email': 'antonio.mangieri@humanitas.it', 'phone': '0282247085'}, {'name': 'Alessandra Cataldo, PhD', 'role': 'CONTACT', 'email': 'alessandra.cataldo@humanitas.it', 'phone': '0282247085'}], 'facility': 'IRCCS Istituo Clinico Humanitas', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}], 'centralContacts': [{'name': 'Antonio Mangieri, MD', 'role': 'CONTACT', 'email': 'antonio.mangieri@humanitas.it', 'phone': '0282243084'}, {'name': 'Ottavia Cozzi, MD', 'role': 'CONTACT', 'email': 'ottavia.cozzi@humanitas.it', 'phone': '0282247070'}], 'overallOfficials': [{'name': 'Antonio Mangieri, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Humanitas Research Horspital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Clinico Humanitas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}