An observational study in Heart Failure, Structural Heart Disease and Interventional Cardiology, sponsored by Nantes University Hospital. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-16.
Sponsored by Nantes University Hospital · 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.
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's planned enrollment of 70 is below the median of 200 across 1,679 observational studies indexed under Heart Failure.
Browse Heart Failure studies →Nantes University Hospital is the lead sponsor of 825 studies on the registry; 195 are open to participants now.
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The study population will include patients referred to Nantes University Hospital for the treatment of significant VHD.
Patients with severe structural heart disease (meeting at least one of the following three criteria):
Exclusion Criteria:
Contraindication to right heart catheterization, including:
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.
Other: 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.
Also known as: Cardiac Catheterization, Hemodynamic Procedure
Correlation with non-invasive echocardiographic parameters
Assessment of diagnostic performances of TAPSE/PAPS, RVFWLS/PAPS and FAC/PAPS ratios compared to Ees/Ea ratio.
Time frame: During right heart catheterization (Day 1)
Plan to share: Undecided
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