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| Name | Class |
|---|---|
| Fédération Française de Cardiologie | OTHER |
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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.
This study aims to improve the assessment of right ventricular (RV) function in patients with valvular heart disease (VHD), by validating non-invasive imaging parameters of right ventricular to pulmonary artery (RV-PA) coupling against invasive measurements using conductance catheters-the gold standard for evaluating RV hemodynamics.
Currently available non-invasive tools do not always provide reliable evaluation of RV-PA coupling. This study seeks to identify accurate imaging surrogates to support clinical decision-making, particularly in conditions such as secondary mitral regurgitation, tricuspid regurgitation, and right-sided structural heart disease.
By correlating non-invasive indices-such as tricuspid annular plane systolic excursion to pulmonary artery systolic pressure ratio (TAPSE/PASP) and RV strain-with invasive data, the study may enhance diagnostic strategies, improve patient care, and support future prognostic and therapeutic investigations. Data may also contribute to post hoc analyses in existing registries and help refine our understanding of RV adaptation in structural heart disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Severe valvular heart disease | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational Invasive Hemodynamic Assessment | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation with non-invasive echocardiographic parameters | Assessment of diagnostic performances of TAPSE/PAPS, RVFWLS/PAPS and FAC/PAPS ratios compared to Ees/Ea ratio. | During right heart catheterization (Day 1) |
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Inclusion Criteria:
Adult patients (≥ 18 years old);
Patients with severe structural heart disease (meeting at least one of the following three criteria):
Exclusion Criteria:
Patients under legal guardianship or protection (e.g., guardianship, trusteeship, or any other legal protection measure);
Pregnant or breastfeeding women;
Vulnerable individuals (e.g., persons deprived of liberty, adults under legal protection);
Contraindication to right heart catheterization, including:
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The study population will include patients referred to Nantes University Hospital for the treatment of significant VHD.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robin LE RUZ, MD, PhD | Contact | 02. 53.48.28.36 | robin.leruz@chu-nantes.fr |
| Name | Affiliation | Role |
|---|---|---|
| Robin LE RUZ, MD, PhD | Hospital of Nantes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU of NANTES | Recruiting | Nantes | Loire Atlantique | 44000 | France |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D006328 | Cardiac Catheterization |
| ID | Term |
|---|---|
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| D002404 | Catheterization |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |