[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601584":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":32,"responsibleParty":51,"collaborators":53,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":10,"enrollmentInfo":66,"targetDuration":10,"studyType":69,"phases":10,"briefSummary":70,"conditions":71,"keywords":75,"overallStatus":35,"whyStopped":10,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Nantes University Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Severe valvular heart disease",null,"Patients with severe Valvular Heart Disease (VHD) will undergo a RV volumetric assessment (MRI, CT, 3D-echocardiography) followed within 72h by an invasive assessment of RV-PA coupling using conductance catheters, either as a preoperative evaluation or at the time of transcatheter valvular intervention. Echocardiographic images will be acquired during right heart catheterization (RHC) in order to be compared to the gold-standard.",[13],"Other: Observational Invasive Hemodynamic Assessment",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"Observational Invasive Hemodynamic Assessment","Collection and analysis of invasive hemodynamic data obtained through routine cardiac catheterization performed as part of standard care. No intervention is mandated by the study protocol.",[9],[20,21],"Cardiac Catheterization","Hemodynamic Procedure",[23],{"name":24,"affiliation":25,"role":26},"Robin LE RUZ, MD, PhD","Hospital of Nantes","PRINCIPAL_INVESTIGATOR",[28],{"name":24,"role":29,"phone":30,"phoneExt":10,"email":31},"CONTACT","02. 53.48.28.36","robin.leruz@chu-nantes.fr",[33],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"CHU of NANTES","RECRUITING","Nantes","Loire Atlantique","44000","France","FR",{"type":42,"coordinates":43},"Point",[44,45],-1.55336,47.21725,{"lat":45,"lon":44},[48],{"name":49,"role":29,"phone":50,"phoneExt":10,"email":31},"ROBIN LE RUZ, cardiologist, MD","02 53 48 28 35",{"type":52,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[54],{"name":55,"class":6},"Fédération Française de Cardiologie","100601584","pressure-volume-loop-assessment-in-valvular-heart-disease-100601584",false,"NCT07112391","Pressure-Volume Loop Assessment in Valvular Heart Disease","Invasive Hemodynamic Study of Structural Heart Diseases: A Monocentric, Non-Randomized Approach","VHD-PV-loop","Inclusion Criteria:\n\n* Adult patients (≥ 18 years old);\n* Patients with severe structural heart disease (meeting at least one of the following three criteria):\n\n  * Heart failure with moderate-to-severe or severe secondary mitral regurgitation\n  * At least severe tricuspid regurgitation\n  * Significant pulmonary valve stenosis and\u002For regurgitation\n\nExclusion Criteria:\n\n* Patients under legal guardianship or protection (e.g., guardianship, trusteeship, or any other legal protection measure);\n* Pregnant or breastfeeding women;\n* Vulnerable individuals (e.g., persons deprived of liberty, adults under legal protection);\n* Contraindication to right heart catheterization, including:\n\n  * Known proximal venous occlusion of the superior or inferior vena cava territory\n  * Presence of a mobile mass in the right heart chambers\n  * Significant tricuspid stenosis","ALL","18 Years",{"count":67,"type":68},70,"ESTIMATED","OBSERVATIONAL","The VHD PV loop study intends to assess invasive right ventricular to pulmonary artery (RV-PA) coupling in patients with valvular heart disease (VHD). Invasive RV-PA coupling is measured by using conductance catheters, the gold standard assessment for ventricular physiology. Several non-invasive parameters have been reported as surrogates for this complex physiological entity, but none of them has been tested against the gold-standard in this population. Based on this, our main objective is to assess the correlation of imaging derived RV-PA coupling in comparison to the invasive measurement.",[72,73,74],"Heart Failure","Structural Heart Disease","Interventional Cardiology",[76,77,78,79],"Chronic heart failure","Structural heart disease","Interventional cardiology","Multimodality imaging","2025-09-09",{"date":82,"type":83},"2025-09-16","ACTUAL",{"date":85,"type":83},"2025-09-04",{"date":87,"type":68},"2027-09-04",{"name":5,"class":6},1]