Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2026-02-28 @ 3:48 AM
Study NCT ID:
NCT07125469
Status:
RECRUITING
Last Update Posted:
2025-08-15
First Post:
2025-08-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Measurements of the Aortic Valve Taken During Surgery With Those Obtained Before Surgery Using Computed Tomography Scans, in Patients Undergoing Surgical Aortic Valve Replacement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019736', 'term': 'Prostheses and Implants'}], 'ancestors': [{'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 82}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-12', 'studyFirstSubmitDate': '2025-08-05', 'studyFirstSubmitQcDate': '2025-08-12', 'lastUpdatePostDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Aortic Valve Annular sizing in Surgical Aortic Valve Replacement', 'timeFrame': 'pre-operative', 'description': 'All patients with severe aortic stenosis (narrowing of the aortic valve) scheduled for Surgical Aortic Valve Replacement (SAVR), which is open-heart surgery to replace the valve with a bioprosthetic (tissue) valve, will have a pre-operative Computed Tomography (CT) scan. This CT scan follows the pre-Transcatheter Aortic Valve Replacement (pre-TAVR) protocol and focuses on the aortic root (the base of the aorta). It uses retrospective electrocardiogram (ECG) gating, a technique that times image capture with the heartbeat to get clear pictures of the heart.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['valve size, Surgical Aortic Valve Replacement'], 'conditions': ['Valvular Heart Disease']}, 'descriptionModule': {'briefSummary': 'This study aims to understand why there may be differences between the measurements of the aortic valve taken before and during surgery. Specifically, it will compare the valve size suggested by a CT scan (Computed Tomography) with the size measured during the operation using surgical tools. This will help determine which method is more accurate for selecting the right valve size in patients undergoing SAVR (Surgical Aortic Valve Replacement ).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatient age 18 years or older\n\nAll patients with isolated severe Aortic Stenosis (AS) considered eligible for Surgical Aortic Valve Replacement (SAVR) according to the current 2023 European Society of Cardiology/European Association for Cardio-Thoracic Surgery (ESC/EACTS) guidelines for management of Valvular Heart Disease (reference 8) will be enrolled.\n\nPatient is willing to comply with study procedures and is available to return to the center for follow-up visits.\n\nInformed consent documentation signed and dated confirming that the patient has been adequately informed of all aspects related to his/her participation in the clinical study and is willing to participate.\n\nExclusion Criteria:\n\nBicuspid aortic valve anatomy Moderate to severe aortic valve regurgitation Multivalvular disease Redo Surgical Aortic Valve Replacement Ascending aorta aneurysm Aortic root enlargement Chronic Kidney Disease with estimated Glomerular Filtration Rate less than 30 milliliters per minute Body Mass Index greater than 30 kilograms per square meter Inadequate Multidetector Computed Tomography images'}, 'identificationModule': {'nctId': 'NCT07125469', 'acronym': 'SAVR-CT-AVA', 'briefTitle': 'Comparing Measurements of the Aortic Valve Taken During Surgery With Those Obtained Before Surgery Using Computed Tomography Scans, in Patients Undergoing Surgical Aortic Valve Replacement', 'organization': {'class': 'OTHER', 'fullName': 'Maria Cecilia Hospital'}, 'officialTitle': 'Intraoperative Assessment Versus Preoperative Multidetector Computed Tomography (MDCT) for Aortic Valve Annular Sizing in Surgical Aortic Valve Replacement (SAVR)"', 'orgStudyIdInfo': {'id': 'SAVR-CT-AVA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Patients with severe AS and indication to SAVR with bioprosthetic valve', 'interventionNames': ['Other: The measurements taken from the CT scan will be used to determine the appropriate size for two types of theoretical Transcatheter Aortic Valve Replacement (TAVR) prostheses']}], 'interventions': [{'name': 'The measurements taken from the CT scan will be used to determine the appropriate size for two types of theoretical Transcatheter Aortic Valve Replacement (TAVR) prostheses', 'type': 'OTHER', 'description': 'All patients with severe aortic stenosis (AS) who are scheduled for Surgical Aortic Valve Replacement (SAVR) with a bioprosthetic valve will undergo a pre-operative Computed Tomography (CT) scan. This CT scan will follow the pre-Transcatheter Aortic Valve Replacement (pre-TAVR) protocol and will focus only on imaging the aortic root, using a method called retrospective electrocardiogram (ECG) gating to capture detailed heart motion.\n\nThe measurements taken from the CT scan will be used to determine the appropriate size for two types of theoretical Transcatheter Aortic Valve Replacement (TAVR) prostheses:', 'armGroupLabels': ['Patients with severe AS and indication to SAVR with bioprosthetic valve']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48033', 'city': 'Cotignola', 'state': 'Ravenna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Elena Tenti', 'role': 'CONTACT', 'email': 'etenti@gvmnet.it', 'phone': '+390545217031'}], 'facility': 'Maria Cecilia Hospital', 'geoPoint': {'lat': 44.38572, 'lon': 11.93852}}], 'centralContacts': [{'name': 'Elena Tenti', 'role': 'CONTACT', 'email': 'etenti@gvmnet.it', 'phone': '+39 0545217031'}], 'overallOfficials': [{'name': 'Fausto Castriota', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maria Cecilia Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Individual participant data (IPD) will not be publicly shared. However, de-identified data may be made available to qualified researchers upon reasonable request to the study center and the Principal Investigator. All data will be processed in compliance with the General Data Protection Regulation (GDPR - EU Regulation 2016/679), ensuring the confidentiality, integrity, and protection of participants' personal information."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maria Cecilia Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}