Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2025-12-26 @ 2:23 AM
Study NCT ID:
NCT07179302
Status:
COMPLETED
Last Update Posted:
2025-12-03
First Post:
2025-09-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pre- and Post-TAVI Patient Assessment: Advancing Outcome Precision in Aortic Valve Therapy
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065467', 'term': 'Transcatheter Aortic Valve Replacement'}], 'ancestors': [{'id': 'D019918', 'term': 'Heart Valve Prosthesis Implantation'}, {'id': 'D006348', 'term': 'Cardiac Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-25', 'studyFirstSubmitDate': '2025-09-10', 'studyFirstSubmitQcDate': '2025-09-11', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Repeated hospitalization in one year', 'timeFrame': 'one year', 'description': 'number of patients need rehospitalization'}, {'measure': 'Need for permanent pacemaker', 'timeFrame': '6 months', 'description': 'number of patients need for permanent pacemaker'}, {'measure': 'Myocardial infarction within one year', 'timeFrame': 'one year', 'description': 'incidence of MI in patients'}, {'measure': 'Stroke in one year', 'timeFrame': 'one year', 'description': 'incidence of stroke in patients'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aortic Valve Stenosis']}, 'referencesModule': {'references': [{'pmid': '37409583', 'type': 'BACKGROUND', 'citation': 'Wu HW, Fortuni F, Butcher SC, van der Kley F, de Weger A, Delgado V, Jukema JW, Bax JJ, Ajmone Marsan N. Prognostic value of left ventricular myocardial work indices in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement. Eur Heart J Cardiovasc Imaging. 2023 Nov 23;24(12):1682-1689. doi: 10.1093/ehjci/jead157.'}, {'pmid': '37085029', 'type': 'BACKGROUND', 'citation': 'Takeuchi K, Yamauchi Y, Shiraki H, Sumimoto K, Shono A, Suzuki M, Yamashita K, Toba T, Kawamori H, Otake H, Hirata KI, Tanaka H. Association of acute improvement in left ventricular longitudinal function after transcatheter aortic valve implantation with outcomes for severe aortic stenosis and preserved ejection fraction. J Cardiol. 2023 Oct;82(4):234-239. doi: 10.1016/j.jjcc.2023.04.008. Epub 2023 Apr 19.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the combined utility of the left atrial coupling index (LACI) and left ventricular speckle tracking echocardiography (LVSTE) in improving risk stratification and outcome prediction for patients undergoing Transcatheter Aortic Valve Implantation (TAVI). This study seeks to identify novel prognostic markers that enhance the prediction of mortality, heart failure, and functional recovery, ultimately enabling more personalized clinical decision-making and optimized patient outcomes by integrating the advanced echocardiographic parameters into pre-procedural assessments,.', 'detailedDescription': 'Transcatheter Aortic Valve Implantation (TAVI) has emerged as a transformative procedure for patients with severe aortic stenosis, particularly those at high surgical risk. However, accurately predicting patient outcomes remains a significant challenge, necessitating improved risk stratification tools. This study aims to evaluate the role of the left atrial coupling index (LACI) and left ventricular speckle tracking echocardiography (LVSTE) in enhancing outcome prediction in patients undergoing TAVI.\n\nBy integrating advanced echocardiographic parameters, such as LACI, which reflects left atrial function and ventricular-atrial interaction, and LVSTE, a sensitive measure of myocardial deformation, this research seeks to uncover novel prognostic markers. A prospective cohort of TAVI patients will be studied to assess the association between these indices and post-procedural outcomes, including Repeated hospitalization, heart failure, stroke and myocardial infarction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '102 Years', 'minimumAge': '50 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with severe aortic stenosis and scheduled for TAVI will be recruited from Madina Cardiac Center over a period of 12 months Data Collection\n\n* Baseline Clinical Data: Demographic information, comorbidities, and clinical risk scores\n* Echocardiographic Assessment:\n\nPre procedural transthoracic echocardiography (TTE) will be performed to measure: Left Atrial Coupling Index (LACI):\n\nLeft Ventricular Speckle Tracking Echocardiography (LVSTE): Global longitudinal strain (GLS) will be measured to quantify myocardial deformation.\n\nAll echocardiographic measurements will be performed by experienced operators blinded to clinical outcomes.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with severe aortic stenosis and scheduled for TAVI.\n\nExclusion Criteria:\n\n* Patients with significant mitral or tricuspid valve disease requiring intervention.\n* History of atrial fibrillation or other arrhythmias that preclude accurate LACI measurement.\n* Poor echocardiographic window preventing reliable imaging.'}, 'identificationModule': {'nctId': 'NCT07179302', 'briefTitle': 'Pre- and Post-TAVI Patient Assessment: Advancing Outcome Precision in Aortic Valve Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Damanhour University'}, 'officialTitle': 'Comparative Evaluation of LACI and LV Speckle Tracking for Pre- and Post-TAVI Patient Assessment: Advancing Outcome Precision in Aortic Valve Therapy', 'orgStudyIdInfo': {'id': 'Aortic Valve Therapy'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'TAVI group', 'description': 'Patients undergoing Transcatheter Aortic Valve Implantation.', 'interventionNames': ['Procedure: Transcatheter Aortic Valve Implantation (TAVI)']}], 'interventions': [{'name': 'Transcatheter Aortic Valve Implantation (TAVI)', 'type': 'PROCEDURE', 'otherNames': ['TAVI'], 'description': 'evaluate the role of the left atrial coupling index (LACI) and left ventricular speckle tracking echocardiography (LVSTE) in enhancing outcome prediction in patients undergoing TAVI.', 'armGroupLabels': ['TAVI group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31527', 'city': 'Tanta', 'state': 'Gharbia Governorate', 'country': 'Egypt', 'facility': 'Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}, {'city': 'Madinah', 'country': 'Saudi Arabia', 'facility': 'Medina Medical Center', 'geoPoint': {'lat': 24.46861, 'lon': 39.61417}}], 'overallOfficials': [{'name': 'Eman Elshaikh, Ass Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Madina Cardiac Center, KSA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Damanhour University', 'class': 'OTHER'}, 'collaborators': [{'name': 'medina medical center', 'class': 'OTHER'}, {'name': 'Tanta University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Rehab Werida', 'investigatorAffiliation': 'Damanhour University'}}}}