Pressure-Volume Loop Assessment in Valvular Heart Disease
Invasive Hemodynamic Study of Structural Heart Diseases: A Monocentric, Non-Randomized Approach
Nantes University Hospital
70 participants
Sep 4, 2025
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- Adult patients (≥ 18 years old);
- Patients with severe structural heart disease (meeting at least one of the following three criteria):
- Heart failure with moderate-to-severe or severe secondary mitral regurgitation
- At least severe tricuspid regurgitation
- Significant pulmonary valve stenosis and/or regurgitation
Exclusion Criteria7
- 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:
- Known proximal venous occlusion of the superior or inferior vena cava territory
- Presence of a mobile mass in the right heart chambers
- Significant tricuspid stenosis
Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07112391