Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT05914051
Status:
UNKNOWN
Last Update Posted:
2023-06-22
First Post:
2023-03-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PRELOAD-TAVI Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-12', 'studyFirstSubmitDate': '2023-03-23', 'studyFirstSubmitQcDate': '2023-06-12', 'lastUpdatePostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Need of inotropes', 'timeFrame': '"1 year"', 'description': 'Yes/no'}, {'measure': 'HR after TAVI', 'timeFrame': '"1 year"', 'description': 'rpm'}], 'primaryOutcomes': [{'measure': 'Cardiac output after valve implant', 'timeFrame': '"1 year"', 'description': 'Cardiac output (l/min) after TAVI'}], 'secondaryOutcomes': [{'measure': 'Stroke volume after valve implant', 'timeFrame': '"1 year"', 'description': 'SV (ml) after TAVI'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['TAVI']}, 'descriptionModule': {'briefSummary': 'The aim is to assess the response of cardiac output and stroke volume to volume preload optimization in patients with severe aortic stenosis treated with aortic prosthesis implantation.', 'detailedDescription': 'Patients with severe aortic stenosis present a maintained overload pressure of the left ventricle that can lead to a progressive hypertrophy. This results in elevated left-sided filling pressures and impaired diastolic function.In this context, paradoxical changes in left ventricular function after aortic valve replacement have been described, with acute decrease of the afterload condition that can result in the development of a dynamic intraventricular gradient, especially in the presence of small ventricles with severe hypertrophy, resulting in hemodynamic collapse.\n\nIn this setting, it is particularly important to ensure accurate left ventricular preload to optimize myocardial contractility and guarantee an adequate hemodynamic response to valve implantation.\n\nPatients with severe aortic stenosis submitted for transfemoral TAVI on spontaneous breathing will be randomly assigned 1:1 to standard care vs volume preload optimization. Non-invasive continuous monitoring (Clear Sight System, Edwards Lifesciences) will be used to evaluate the cardiac output and the stroke volume in both groups, comparing the hemodynamics before and after valve implant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '110 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aortic valve stenosis with echocardiographic derived criteria: mean gradient \\>40 mmHg or jet velocity greater than 4.0 m/s or an initial aortic valve area of \\< 0.8 cm2\n\nExclusion Criteria:\n\n* Cardiogenic shock.\n* Life expectancy \\< 1 year.\n* Need of mechanic ventilation.'}, 'identificationModule': {'nctId': 'NCT05914051', 'acronym': 'PRELOAD-TAVI', 'briefTitle': 'PRELOAD-TAVI Trial', 'organization': {'class': 'OTHER', 'fullName': 'Fundación de investigación HM'}, 'officialTitle': 'PRELOAD TAVI Trial: Prospective Randomized Trial of Volume Preload Optimization in Patients With Severe Aortic Stenosis Treated on Spontaneous Breathing With Transfemoral TAVI', 'orgStudyIdInfo': {'id': 'PRELOAD-TAVI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Volume preload optimization.', 'description': 'Volume overload with 250 cc saline solution will be performed in the intervention arm, verifying the response of the cardiac output and stroke volume with non invasive continue monitoring.', 'interventionNames': ['Other: Colloid preload']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Standard care without volume preload.'}], 'interventions': [{'name': 'Colloid preload', 'type': 'OTHER', 'description': '250 cc of colloid preload solution will be infused in the intervention group', 'armGroupLabels': ['Volume preload optimization.']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Leire Unzue, PhD', 'role': 'CONTACT', 'email': 'leireunzue@yahoo.es', 'phone': '0034917089900'}, {'name': 'Miguel Rodríguez del Río, MD', 'role': 'CONTACT', 'email': 'mrrio1980@gmail.com', 'phone': '0034917089900'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'timeFrame': 'At recruitment and after study conclusion', 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación de investigación HM', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PRELOAD-TAVI Trial', 'investigatorFullName': 'Leire Unzue Vallejo', 'investigatorAffiliation': 'Fundación de investigación HM'}}}}