Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:20 AM
Study NCT ID:
NCT07483203
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-19
First Post:
2026-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Of Clinical Implications Of Pulmonary Vascular Disease In Valvular Heart Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004452', 'term': 'Echocardiography'}], 'ancestors': [{'id': 'D057791', 'term': 'Cardiac Imaging Techniques'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2028-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-16', 'studyFirstSubmitDate': '2026-03-16', 'studyFirstSubmitQcDate': '2026-03-16', 'lastUpdatePostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tricuspid Regurgitation (TR) reduction', 'timeFrame': 'Baseline, 12 months', 'description': 'Tricuspid Regurgitation (TR) reduction will be defined as ≥1 grade reduction'}, {'measure': 'Right Ventricular function improvement', 'timeFrame': 'Baseline, 12 months', 'description': 'Right Ventricular function improvement will be defined as ≥5% in Right Ventricular free wall longitudinal strain'}], 'secondaryOutcomes': [{'measure': 'Number of Hospitalizations', 'timeFrame': '12 months', 'description': 'Number of Hospitalizations will be determined by the number of patients admitted to the hospital post procedure'}, {'measure': 'Number of Deaths', 'timeFrame': '12 months', 'description': 'Number of Death will be determined by the number of patients that pass away post procedure due to any cause'}, {'measure': 'Kansas City Cardiomyopathy Questionnaire (KCCQ)', 'timeFrame': 'Baseline, 6 months, and 12 months', 'description': "KCCQ is a 12-item questionnaires that measure the participant's perception of their health status, including their heart failure (HF) symptoms, impact on physical and social function and how their HF impacts the quality of life. Scores were generated for each domain and scaled from 0 to 70, with 0 (worst) and 70 (the best possible status), where the higher score reflected better health status."}, {'measure': 'Right atrial area change', 'timeFrame': 'Baseline', 'description': 'Right atrial area change is used to assess right vascular function. It will measure the area of change within the right ventricle between diastole and systole as a percentage.'}, {'measure': 'Tricuspid annular plane systolic excursion (TAPSE)', 'timeFrame': 'Baseline', 'description': 'Tricuspid annular plane systolic excursion will be used to measure right ventricular function and measured in mm (millimeters)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary Vascular Disease', 'Valvular Heart Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to characterize pulmonary hemodynamic profiles, with a focus on PVR subtypes, in patients with left-sided valvular heart disease undergoing aortic or mitral valve intervention, and to identify patterns predicting reversibility of TR and RV dysfunction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will consist of patients scheduled to undergo transcatheter aortic, mitral, or tricuspid valve interventions at Mayo Clinic Rochester.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥18 years old; AND\n* Scheduled for valve procedures\n\nExclusion Criteria:\n\n* Congenital heart disease (except for bicuspid aortic valve), OR\n* Carcinoid heart disease, OR\n* Valvular mass, OR\n* Endocarditis, OR\n* Any other condition that, in the opinion of the investigator, would impair their ability to complete the study'}, 'identificationModule': {'nctId': 'NCT07483203', 'briefTitle': 'A Study Of Clinical Implications Of Pulmonary Vascular Disease In Valvular Heart Disease', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Clinical Implications of Pulmonary Vascular Disease in Valvular Heart Disease', 'orgStudyIdInfo': {'id': '26-000174'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Aortic Intervention', 'interventionNames': ['Diagnostic Test: Echocardiogram']}, {'label': 'Mitral Intervention', 'interventionNames': ['Diagnostic Test: Echocardiogram']}, {'label': 'Tricuspid intervention', 'interventionNames': ['Diagnostic Test: Echocardiogram']}], 'interventions': [{'name': 'Echocardiogram', 'type': 'DIAGNOSTIC_TEST', 'description': "An echocardiogram will be performed during the patient's routinely scheduled right heart catheterization.", 'armGroupLabels': ['Aortic Intervention', 'Mitral Intervention', 'Tricuspid intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'centralContacts': [{'name': 'Annabelle Fuenffinger', 'role': 'CONTACT', 'email': 'fuenffinger.annabelle@mayo.edu', 'phone': '507-422-3801'}], 'overallOfficials': [{'name': 'Barry Borlaug, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Barry Borlaug', 'investigatorAffiliation': 'Mayo Clinic'}}}}